Higher versus lower sodium intake for preterm infants.

BACKGROUND: Infants born preterm are at increased risk of early hypernatraemia (above-normal blood sodium levels) and late hyponatraemia (below-normal blood sodium levels). There are concerns that imbalances of sodium intake may impact neonatal morbidities, growth and developmental outcomes. OBJECTIVES: To determine the effects of higher versus lower sodium supplementation in preterm infants. SEARCH METHODS: We searched CENTRAL in February 2023; and MEDLINE, Embase and trials registries in March and April 2022. We checked reference lists of included studies and systematic reviews where subject matter related to the intervention or population examined in this review. We compared early (< 7 days following birth), late (≥ 7 days following birth), and early and late sodium supplementation, separately. SELECTION CRITERIA: We included randomised, quasi-randomised or cluster-randomised controlled trials that compared nutritional supplementation that included higher versus lower sodium supplementation in parenteral or enteral intake, or both. Eligible participants were preterm infants born before 37 weeks' gestational age or with a birth weight less than 2500 grams, or both. We excluded studies that had prespecified differential water intakes between groups. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed eligibility and risk of bias, and extracted data. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS: We included nine studies in total. However, we were unable to extract data from one study (20 infants); some studies contributed to more than one comparison. Eight studies (241 infants) were available for quantitative meta-analysis. Four studies (103 infants) compared early higher versus lower sodium intake, and four studies (138 infants) compared late higher versus lower sodium intake. Two studies (103 infants) compared intermediate sodium supplementation (≥ 3 mmol/kg/day to < 5 mmol/kg/day) versus no supplementation, and two studies (52 infants) compared higher sodium supplementation (≥ 5 mmol/kg/day) versus no supplementation. We assessed only two studies (63 infants) as low risk of bias. Early (less than seven days following birth) higher versus lower sodium intake Early higher versus lower sodium intake may not affect mortality (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.38 to 2.72; I2 = 0%; 3 studies, 83 infants; low-certainty evidence). Neurodevelopmental follow-up was not reported. Early higher versus lower sodium intake may lead to a similar incidence of hyponatraemia < 130 mmol/L (RR 0.68, 95% CI 0.40 to 1.13; I2 = 0%; 3 studies, 83 infants; low-certainty evidence) but an increased incidence of hypernatraemia ≥ 150 mmol/L (RR 1.62, 95% CI 1.00 to 2.65; I2 = 0%; 4 studies, 103 infants; risk difference (RD) 0.17, 95% CI 0.01 to 0.34; number needed to treat for an additional harmful outcome 6, 95% CI 3 to 100; low-certainty evidence). Postnatal growth failure was not reported. The evidence is uncertain for an effect on necrotising enterocolitis (RR 4.60, 95% CI 0.23 to 90.84; 1 study, 46 infants; very low-certainty evidence). Chronic lung disease at 36 weeks was not reported. Late (seven days or more following birth) higher versus lower sodium intake Late higher versus lower sodium intake may not affect mortality (RR 0.13, 95% CI 0.01 to 2.20; 1 study, 49 infants; very low-certainty evidence). Neurodevelopmental follow-up was not reported. Late higher versus lower sodium intake may reduce the incidence of hyponatraemia < 130 mmol/L (RR 0.13, 95% CI 0.03 to 0.50; I2 = 0%; 2 studies, 69 infants; RD -0.42, 95% CI -0.59 to -0.24; number needed to treat for an additional beneficial outcome 2, 95% CI 2 to 4; low-certainty evidence). The evidence is uncertain for an effect on hypernatraemia ≥ 150 mmol/L (RR 7.88, 95% CI 0.43 to 144.81; I2 = 0%; 2 studies, 69 infants; very low-certainty evidence). A single small study reported that later higher versus lower sodium intake may reduce the incidence of postnatal growth failure (RR 0.25, 95% CI 0.09 to 0.69; 1 study; 29 infants; low-certainty evidence). The evidence is uncertain for an effect on necrotising enterocolitis (RR 0.07, 95% CI 0.00 to 1.25; 1 study, 49 infants; very low-certainty evidence) and chronic lung disease (RR 2.03, 95% CI 0.80 to 5.20; 1 study, 49 infants; very low-certainty evidence). Early and late (day 1 to 28 after birth) higher versus lower sodium intake for preterm infants Early and late higher versus lower sodium intake may not have an effect on hypernatraemia ≥ 150 mmol/L (RR 2.50, 95% CI 0.63 to 10.00; 1 study, 20 infants; very low-certainty evidence). No other outcomes were reported. AUTHORS' CONCLUSIONS: Early (< 7 days following birth) higher sodium supplementation may result in an increased incidence of hypernatraemia and may result in a similar incidence of hyponatraemia compared to lower supplementation. We are uncertain if there are any effects on mortality or neonatal morbidity. Growth and longer-term development outcomes were largely unreported in trials of early sodium supplementation. Late (≥ 7 days following birth) higher sodium supplementation may reduce the incidence of hyponatraemia. We are uncertain if late higher intake affects the incidence of hypernatraemia compared to lower supplementation. Late higher sodium intake may reduce postnatal growth failure. We are uncertain if late higher sodium intake affects mortality, other neonatal morbidities or longer-term development. We are uncertain if early and late higher versus lower sodium supplementation affects outcomes.

Nasal interfaces for neonatal resuscitation.

BACKGROUND: The Neonatal Task Force of the International Liaison Committee on Resuscitation (ILCOR) makes practice recommendations for the care of newborn infants in the delivery room (DR). ILCOR recommends that all infants who are gasping, apnoeic, or bradycardic (heart rate < 100 per minute) should be given positive pressure ventilation (PPV) with a manual ventilation device (T-piece, self-inflating bag, or flow-inflating bag) via an interface. The most commonly used interface is a face mask that encircles the infant's nose and mouth. However, gas leak and airway obstruction are common during face mask PPV. Nasal interfaces (single and binasal prongs (long or short), or nasal masks) and laryngeal mask airways (LMAs) may also be used to deliver PPV to newborns in the DR, and may be more effective than face masks. OBJECTIVES: To determine whether newborn infants receiving PPV in the delivery room with a nasal interface compared to a face mask, laryngeal mask airway (LMA), or another type of nasal interface have reduced mortality and morbidity. To assess whether safety and efficacy of the nasal interface differs according to gestational age or ventilation device. SEARCH METHODS: Searches were conducted in September 2022 in CENTRAL, MEDLINE, Embase, Epistemonikos, and two trial registries. We searched conference abstracts and checked the reference lists of included trials and related systematic reviews identified through the search. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCT's that compared the use of nasal interfaces to other interfaces (face masks, LMAs, or one nasal interface to another) to deliver PPV to newborn infants in the DR. DATA COLLECTION AND ANALYSIS: Each review author independently evaluated the search results against the selection criteria, screened retrieved records, extracted data, and appraised the risk of bias. If they were study authors, they did not participate in the selection, risk of bias assessment, or data extraction related to the study. In such instances, the study was independently assessed by other review authors. We contacted trial investigators to obtain additional information. We completed data analysis according to the standards of Cochrane Neonatal, using risk ratio (RR) and 95% confidence Intervals (CI) to measure the effect of the different interfaces. We used fixed-effect models and the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included five trials, in which 1406 infants participated. They were conducted in 13 neonatal centres across Europe and Australia. Each of these trials compared a nasal interface to a face mask for the delivery of respiratory support to newborn infants in the DR. Potential sources of bias were a lack of blinding to treatment allocation of the caregivers and investigators in all trials. The evidence suggests that resuscitation with a nasal interface in the DR, compared with a face mask, may have little to no effect on reducing death before discharge (typical risk ratio (RR) 0.72, 95% CI 0.47 to 1.13; 3 studies, 1124 infants; low-certainty evidence). Resuscitation with a nasal interface may reduce the rate of intubation in the DR, but the evidence is very uncertain (RR 0.68, 95% CI 0.54 to 0.85; 5 studies, 1406 infants; very low-certainty evidence). The evidence is very uncertain for the rate of intubation within 24 hours of birth (RR 0.97, 95% CI 0.85 to 1.09; 3 studies, 749 infants; very low-certainty evidence), endotracheal intubation outside the DR during hospitalisation (RR 1.15, 95% CI 0.93 to 1.42; 1 study, 144 infants; very low-certainty evidence) and cranial ultrasound abnormalities (intraventricular haemorrhage (IVH) grade ≥ 3, or periventricular leukomalacia; RR 0.94, 95% CI 0.55 to 1.61; 3 studies, 749 infants; very low-certainty evidence). Resuscitation with a nasal interface in the DR, compared with a face mask, may have little to no effect on the incidence of air leaks (RR 1.09, 95% CI 0.85 to 1.09; 2 studies, 507 infants; low-certainty evidence), or the need for supplemental oxygen at 36 weeks' corrected gestational age (RR 1.06, 95% CI 0.8 to 1.40; 2 studies, 507 infants; low-certainty evidence). We identified one ongoing study, which compares a nasal mask to a face mask to deliver PPV to infants in the DR. We did not identify any completed trials that compared nasal interfaces to LMAs or one nasal interface to another. AUTHORS' CONCLUSIONS: Nasal interfaces were found to offer comparable efficacy to face masks (low- to very low-certainty evidence), supporting resuscitation guidelines that state that nasal interfaces are a comparable alternative to face masks for providing respiratory support in the DR. Resuscitation with a nasal interface may reduce the rate of intubation in the DR when compared with a face mask. However, the evidence is very uncertain. This uncertainty is attributed to the use of a new ventilation system in the nasal interface group in two of the five trials. As such, it is not possible to differentiate separate, specific effects related to the ventilation device or to the interface in these studies.

Cerebral oximetry monitoring versus usual care for extremely preterm infants: a study protocol for the 2-year follow-up of the SafeBoosC-III randomised clinical trial.

BACKGROUND: In the SafeBoosC-III trial, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth did not reduce the incidence of death or severe brain injury in extremely preterm infants at 36 weeks' postmenstrual age, as compared with usual care. Despite an association between severe brain injury diagnosed in the neonatal period and later neurodevelopmental disability, this relationship is not always strong. The objective of the SafeBoosC-III follow-up study is to assess mortality, neurodevelopmental disability, or any harm in trial participants at 2 years of corrected age. One important challenge is the lack of funding for local costs for a trial-specific assessment. METHODS: Of the 1601 infants randomised in the SafeBoosC-III trial, 1276 infants were alive at 36 weeks' postmenstrual age and will potentially be available for the 2-year follow-up. Inclusion criteria will be enrollment in a neonatal intensive care unit taking part in the follow-up study and parental consent if required by local regulations. We aim to collect data from routine follow-up programmes between the ages of 18 and 30 months of corrected age. If no routine follow-up has been conducted, we will collect informal assessments from other health care records from the age of at least 12 months. A local co-investigator blinded to group allocation will classify outcomes based on these records. We will supplement this with parental questionnaires including the Parent Report of Children's Abilities-Revised. There will be two co-primary outcomes: the composite of death or moderate or severe neurodevelopmental disability and mean Bayley-III/IV cognitive score. We will use a 3-tier model for prioritisation, based on the quality of data. This approach has been chosen to minimise loss to follow-up assuming that little data is better than no data at all. DISCUSSION: Follow-up at the age of 2 years is important for intervention trials in the newborn period as only time can show real benefits and harms later in childhood. To decrease the risk of generalisation and data-driven biased conclusions, we present a detailed description of the methodology for the SafeBoosC-III follow-up study. As funding is limited, a pragmatic approach is necessary. TRIAL REGISTRATION: ClinicalTrials.gov NCT05134116 . Registered on 24 November 2021.

Surfactant therapy guided by tests for lung maturity in preterm infants at risk of respiratory distress syndrome.

BACKGROUND: Administration of various exogenous surfactant preparations has been shown to decrease lung injury and pneumothorax and improve survival in very preterm infants with respiratory distress syndrome (RDS). There is no consensus on the threshold for surfactant administration, to allow timely intervention and avoid over-treatment, also considering the invasiveness of the procedure and its cost. Rapid tests for lung maturity, which include the click test, lamellar body counts and stable microbubble test, might guide the identification of those infants needing surfactant administration. OBJECTIVES: To assess the effects of surfactant treatment guided by rapid tests for surfactant deficiency in preterm infants at risk for or having RDS. Comparison 1: In preterm infants at risk for RDS, does surfactant treatment guided by rapid tests for surfactant deficiency compared to prophylactic surfactant administration to all high-risk infants minimize the need for surfactant treatment and prevent bronchopulmonary dysplasia and mortality? Comparison 2: In preterm infants who require early respiratory support, does surfactant treatment guided by rapid tests for surfactant deficiency compared to surfactant therapy provided to infants with RDS diagnosed on clinical and radiologic criteria minimize the need for surfactant treatment and prevent bronchopulmonary dysplasia and mortality? SEARCH METHODS: We searched in October 2022 CENTRAL, PubMed, Embase and three additional trial registries. We also screened the reference lists of included studies and related systematic reviews for studies not identified by the database searches. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and quasi-RCTs evaluating rapid tests after birth for surfactant deficiency in infants at high risk of RDS or requiring respiratory support. We specified two comparisons: 1)surfactant treatment guided by rapid tests for surfactant deficiency versus prophylactic surfactant administration to all high-risk infants in extremely preterm (less than 28 weeks' gestation) and very preterm (28 to 32 weeks' gestation); 2)surfactant treatment guided by rapid tests for surfactant deficiency versus surfactant therapy provided to preterm infants (less than 37 weeks' gestation) with RDS diagnosed on clinical and radiologic criteria. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. We used the fixed-effect model with risk ratio (RR) and risk difference (RD), with their 95% confidence intervals (CIs) for dichotomous data. Our primary outcomes were: neonatal mortality, mortality prior to hospital discharge, bronchopulmonary dysplasia and the composite outcome bronchopulmonary dysplasia or mortality. We used GRADE to assess the certainty of evidence. MAIN RESULTS: We included three RCTs enrolling 562 newborn infants in this review. No studies compared surfactant treatment guided by rapid tests for surfactant deficiency versus prophylactic surfactant administration to all high-risk infants. Comparing surfactant therapy guided by rapid tests for surfactant deficiency versus surfactant therapy provided to infants with RDS diagnosed on clinical and radiologic criteria. No studies reported neonatal mortality. Compared with surfactant therapy provided to infants with RDS diagnosed on clinical and radiologic criteria, the evidence is very uncertain about the effect of surfactant treatment guided by rapid tests for surfactant deficiency on mortality prior to hospital discharge: RR 1.25, 95% CI 0.65 to 2.41, RD 0.01, 95% CI -0.03 to 0.05, 562 participants, 3 studies; I² for RR and RD = 75% and 43%, respectively; very low-certainty evidence. Surfactant treatment guided by rapid tests for surfactant deficiency may result in little to no difference in bronchopulmonary dysplasia: RR 0.90, 95% CI 0.61 to 1.32, RD -0.02, 95% CI -0.08 to 0.04, 562 participants, 3 studies; I² for RR and RD = 0%; low-certainty evidence. No studies reported the composite outcome bronchopulmonary dysplasia or mortality. Surfactant treatment guided by rapid tests for surfactant deficiency may result in little to no difference in surfactant utilization (RR 0.97, 95% CI 0.85 to 1.11, RD -0.02, 95% CI -0.10 to 0.06, 562 participants, 3 studies, I² for RR and RD = 63% and 65%, respectively, low-certainty evidence), and any pneumothorax (RR 0.53, 95% CI 0.15 to 1.92, RD -0.01, 95% CI -0.04 to 0.01, 506 participants, 2 studies, I² for RR and RD = 0%, low-certainty evidence) compared with surfactant therapy provided to infants with RDS diagnosed on clinical and radiologic criteria. No studies reported moderate to severe neurodevelopmental impairment. We identified two large ongoing RCTs. AUTHORS' CONCLUSIONS: No studies compared surfactant treatment guided by rapid tests for surfactant deficiency to prophylactic surfactant administration to all high-risk infants. Low to very low-certainty evidence from three studies is available on surfactant therapy guided by rapid tests for surfactant deficiency versus surfactant therapy provided to infants with RDS diagnosed on clinical and radiologic criteria. No studies reported neonatal mortality, the composite outcome 'bronchopulmonary dysplasia or mortality', or neurodevelopmental outcomes. Compared with surfactant therapy provided to infants with RDS diagnosed on clinical and radiologic criteria, the evidence is very uncertain about the effect of surfactant treatment guided by rapid tests for surfactant deficiency on mortality prior to hospital discharge. Surfactant treatment guided by rapid tests for surfactant deficiency may result in little to no difference in bronchopulmonary dysplasia, surfactant utilization and any pneumothorax. The findings of the two large ongoing trials identified in this review are likely to have an important impact on establishing the effects of surfactant treatment guided by rapid tests for surfactant deficiency in preterm infants.

Interventions to prevent unintended pregnancies among adolescents: a rapid overview of systematic reviews.

Risks associated with unintended pregnancy include unsafe abortions, poor maternal health-seeking behaviour, poor mental health, and potentially, maternal and infant deaths. Adolescent girls with unintended pregnancies are particularly vulnerable as they are at higher risk of eclampsia, premature onset of labour, and increased neonatal morbidity and mortality. Unintended pregnancy, with the right combination of interventions, can be avoided. Evidence-based decision-making and the need for a robust appraisal of the evidence have resulted in many systematic reviews. This review of systematic reviews focuses on adolescent pregnancy prevention and will seek to facilitate evidence-based decision-making. Two review authors independently extracted data and assessed the methodological quality of each review according to the AMSTAR 2 criteria. We identified three systematic reviews from low- and middle-income countries and high-income counties and included all socioeconomic groups. We used vote counting and individual narrative review summaries to present the results. Overall, skill-building, peer-led and abstinence programmes were generally effective. Interventions focused on information only, counselling and interactive sessions provided mixed results.In contrast, exposure to parenting and delaying sexual debut interventions were generally ineffective. Adolescent pregnancy prevention interventions that deploy school-based primary prevention strategies, i.e. strategies that prevent unintended pregnancies in the first place, may effectively reduce teenage pregnancy rates, improve contraceptive use, attitudes and knowledge, and delay sexual debut. However, the included studies have methodological issues, and our ability to generalise the result is limited.

FIGO good practice recommendations: Bundle of care to reduce neonatal mortality and improve outcomes after preterm and term delivery.

An integrated approach is lacking for the management of childbirth and newborn care, even though their codependence is critical for improving maternal and newborn outcomes. FIGO's Prep-for-Labor rapid triage methods for women arriving at a clinical facility are addressed in earlier papers in this Supplement, but do not include newborn care. Immediate postpartum rapid triage using established Apgar score helps determine whether standard of care can be followed on site with available staff/tools. If not, newborn transfer alone or with the mother to a higher-level center as soon as feasible may be required. Updated newborn management tools with special emphasis on pragmatic steps that are applicable for any clinical setting including low- and middle-income countries (LMICs) are presented in this article. Given that more than 80% of newborn care can be managed at the birthing facility, transfer to a higher-level center for care is required only in selected cases. Management steps for healthy newborns are described and the actions needed for those requiring resuscitation are summarized. The simple noninvasive kangaroo mother care approach-universally applicable for both term and preterm newborns-is associated with a significant reduction in morbidity and mortality. Kangaroo mother care involves continuous maternal skin-to skin contact from birth, exclusive breastfeeding, and home support after discharge. Hence, hypothermia, hypoglycemia, and acquired infections are frequently prevented. It is anticipated that implementing simple noninvasive management steps will have a substantial positive impact on improving maternal and newborn outcomes.

Incidence and risk factors of neonatal bacterial infections: a community-based cohort from Madagascar (2018-2021).

BACKGROUND: Few studies on neonatal severe bacterial infection are available in LMICs. Data are needed in these countries to prioritize interventions and decrease neonatal infections which are a primary cause of neonatal mortality. The BIRDY project (Bacterial Infections and Antimicrobial Drug Resistant among Young Children) was initially conducted in Madagascar, Senegal and Cambodia (BIRDY 1, 2012-2018), and continued in Madagascar only (BIRDY 2, 2018-2021). We present here the BIRDY 2 project whose objectives were (1) to estimate the incidence of neonatal severe bacterial infections and compare these findings with those obtained in BIRDY 1, (2) to identify determinants associated with severe bacterial infection and (3) to specify the antibiotic resistance pattern of bacteria in newborns. METHODS: The BIRDY 2 study was a prospective community-based mother and child cohort, both in urban and semi-rural areas. All pregnant women in the study areas were identified and enrolled. Their newborns were actively and passively followed-up from birth to 3 months. Data on clinical symptoms developed by the children and laboratory results of all clinical samples investigated were collected. A Cox proportional hazards model was performed to identify risk factors associated with possible severe bacterial infection. FINDINGS: A total of 53 possible severe bacterial infection and 6 confirmed severe bacterial infection episodes were identified among the 511 neonates followed-up, with more than half occurring in the first 3 days. For the first month period, the incidence of confirmed severe bacterial infection was 11.7 per 1,000 live births indicating a 1.3 -fold decrease compared to BIRDY 1 in Madagascar (p = 0.50) and the incidence of possible severe bacterial infection was 76.3, indicating a 2.6-fold decrease compared to BIRDY 1 in Madagascar (p < 0.001). The 6 severe bacterial infection confirmed by blood culture included 5 Enterobacterales and one Enterococcus faecium. The 5 Enterobacterales were extended-spectrum ß-lactamases (ESBL) producers and were resistant to quinolones and gentamicin. Enterococcus faecium was sensitive to vancomycin but resistant to amoxicillin and to gentamicin. These pathogns were classified as multidrug-resistant bacteria and were resistant to antibiotics recommended in WHO guidelines for neonatal sepsis. However, they remained susceptible to carbapenem. Fetid amniotic fluid, need for resuscitation at birth and low birth weight were associated with early onset possible severe bacterial infection. CONCLUSION: Our results suggest that the incidence of severe bacterial infection is still high in the community of Madagascar, even if it seems lower when compared to BIRDY 1 estimates, and that existing neonatal sepsis treatment guidelines may no longer be appropriate in Madagascar. These results motivate to further strengthen actions for the prevention, early diagnosis and case management during the first 3 days of life.

FIGO good practice recommendations for preterm labor and preterm prelabor rupture of membranes: Prep-for-Labor triage to minimize risks and maximize favorable outcomes.

Preterm labor occurs in around 10% of pregnancies worldwide. Once diagnosed, significant efforts must be made to reduce the likelihood of morbidity and mortality associated with preterm birth. In high-resource settings, access to hospitals with a neonatal intensive care unit (NICU) is readily available, whereas access to NICU care is limited in low- and middle-income countries (LMICs) and many rural settings. Use of FIGO's Prep-for-Labor triage method rapidly identifies low- and high-risk patients with preterm labor to enable clinicians to decide whether the patient can be managed on site or if transfer to a level II-IV facility is needed. The management steps described in this paper aim to minimize the morbidity and mortality associated with preterm labor and in the setting of preterm labor with preterm premature rupture of membranes (PPROM). The methods for accurate diagnosis of PPROM and chorioamnionitis are described. When the risk of preterm birth is high, antenatal corticosteroids should be administered for lung maturation combined with limited tocolysis for 48 hours to permit the corticosteroid course to be completed. Magnesium sulfate is also administered for fetal neuroprotection. Implementation of FIGO's Prep-for-Labor triage method in an LMIC setting will help improve maternal and neonatal outcomes.

T-Piece resuscitator versus self-inflating bag for delivery room resuscitation in preterm neonates: a randomized controlled trial.

The establishment of adequate ventilation is the cornerstone of neonatal resuscitation in the delivery room (DR). This parallel-group, accessor-blinded randomized controlled trial compared the changes in peripheral oxygen saturation (SpO2), heart rate (HR), and cerebral regional oxygen saturation (crSO2) with the use of a T-piece resuscitator (TPR) versus self-inflating bag (SIB) as a mode of providing positive pressure ventilation (PPV) during DR resuscitation in preterm neonates. Seventy-two preterm neonates were randomly allocated to receive PPV with TPR (n = 36) or SIB (n = 36). The primary outcome was SpO2 (%) at 5 min. The secondary outcomes included the time to achieve a SpO2 ≥ 80% and > 85%, HR > 100/min, fractional-inspired oxygen (FiO2) requirement, minute-specific SpO2, HR and FiO2 trends for the first 5 min of life, need for DR-intubation, crSO2, need and duration of respiratory support, and other in-hospital morbidities. Mean SpO2 at 5 min was 74.5 ± 17.8% and 69.4 ± 22.4%, in TPR and SIB groups, respectively [Mean difference, 95% Confidence Interval 5.08 (-4.41, 14.58); p = 0.289]. No difference was observed in the time to achieve a SpO2 ≥ 80% and > 85%, HR > 100/min, the requirement of FiO2, DR-intubation, and the need and duration of respiratory support. There was no significant difference in the minute-specific SpO2, HR, and FiO2 requirements for the first 5 min. CrSO2 (%) at one hour was lower by 5% in the TPR group compared to SIB; p = 0.03. Other complications were comparable. CONCLUSIONS: TPR and SIB resulted in comparable SpO2 at 5 min along with similar minute-specific SpO2, HR, and FiO2 trends. CLINICAL TRIAL REGISTRATION: Clinical trial registry of India, Registration no: CTRI/2021/10/037384, Registered prospectively on: 20/10/2021, https://ctri.icmr.org.in/ . WHAT IS KNOWN: • Compared to self-inflating bags (SIB), T-piece resuscitators (TPR) provide more consistent inflation pressure and tidal volume as shown in animal and bench studies. • There is no strong recommendation for one device over the other in view of low certainty evidence. WHAT IS NEW: • TPR and SIB resulted in comparable peripheral oxygen saturation (SpO2) at 5 min along with similar minute-specific SpO2, heart rate, and fractional-inspired oxygen requirement trends. • Short-term complications and mortality rates were comparable with both devices.

Can Neonatal Pull-through Replace Staged Pull-through for the Management of Anorectal Malformation? A Systematic Review and Meta-analysis.

Anorectal malformations (ARMs) are managed classically in three stages - colostomy at birth, anorectal pull-through after 2-3 months, and stoma closure. Single-stage pull-through has been contemplated in neonatal age aimed to reduce the number of procedures, better long-term continence, the better psycho-social status of the child, and reduced cost of treatment, especially in resource-strained countries. We conducted a systematic review comparing neonatal single-stage pull-through with stage pull-through and did a meta-analysis for the outcome and complications. Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines were followed. PubMed and Scopus databases were searched and RevMan 5.4.1 was used for the meta-analysis. Fourteen comparative studies including one randomized controlled trial were included in the systematic review for meta-analysis. The meta-analysis included 1845 patients including 866 neonates undergoing single-stage pull-through. There was no statistically significant difference for the occurrence of surgical site infection (odds ratio [OR] 0.82, 95% confidence interval [CI]: 0.24-2.83), urinary tract injury (OR 1.82, 95% CI: 0.85-3.89), rectal prolapse (OR 0.98, 95% CI: 0.21-5.04), anal stenosis/stricture, voluntary bowel movements (OR 0.97, 95% CI: 0.25-3.73), constipation (OR 1.01, 95% CI: 0.61-1.67), soiling (OR 0.89, 95% CI: 0.52-1.51), mortality (OR 1.19, 95% CI: 0.04-39.74), or other complications. However, continence was seen to be better among patients undergoing neonatal pull-through (OR 1.63, 95% CI: 1.12-2.38). Thus, we can recommend single-stage pull-through for managing patients with ARMs in the neonatal age.

Hats Off for Full-Term Healthy Newborns: No Benefits for Thermoregulation.

BACKGROUND: Hyperthermia is a known risk for sudden unexpected infant death. The practice of hat placement at birth to prevent transient hypothermia may not be necessary and sets an early standard for clothing infants that may lead to hyperthermia postnatally. OBJECTIVE: To examine the elimination of hats on thermoregulation (eg, hypothermia, <97.6°F) in full-term newborns with no abnormalities within 24 hours of birth. METHODS: In 2018, an institution guideline discontinued the use of hats at birth. Subsequently, newborn body temperatures were respectively extracted from electronic health records and data were compared from 482 infants (>38 weeks' gestation and newborn birth weight >2500 g) prior to ( n = 257) and following ( n = 225) the practice change. Body temperatures prior to and after the practice change to eliminate hats use were compared. RESULTS: No statistically significant difference was observed: (1) in the proportion of infants experiencing hypothermia with or without hat use, respectively, 23.7% compared with 31.1% ( P = .09) and (2) in the odds of an infant experiencing hypothermia when adjusting for relevant covariates (odds ratio = 1.44; 95% confidence interval 0.89-2.32; P = .14). CONCLUSIONS: Our findings demonstrate that the use of hats on infants at birth had no measurable impact on newborn thermoregulation.

Adaptation and implementation of clinical guidelines on maternal and newborn postnatal care in Iran: study protocol.

BACKGROUND: According to World Health Organization (WHO), the postnatal care provision aims to provide care and treatment with the highest quality and the least intervention to obtain the best health and well-being for the family. The present study aims to adapt international guidelines for the clinical recommendations for the postpartum period and implement and determine its effectiveness. METHODS/DESIGN: This study will be done in two phases. In the first phase, international clinical guidelines for mother and newborn postnatal care will be adapted. The second phase is a randomized controlled trial in which the adapted guideline recommendations will be implemented, and maternal and neonatal outcomes will be measured. The ADAPTE method for adaptation of clinical guidelines, is usedg in the first phase. A systematic review was conducted in the databases and clinical guidelines related to postpartum care were extracted according to the inclusion criteria. The quality of clinical guidelines was evaluated using the AGREE-II tool. The WHO clinical guideline obtained the highest evaluation score and was chosen as the main guideline, and the NICE clinical guideline, with a second higher evaluation score, was also used to fill some gaps in the WHO guideline. Based on the pre-determined questions, recommendations will be sent to the relevant experts and stakeholders for their evaluation. After the external evaluation and the finalization of the recommendations, the postpartum clinical guideline will be compiled and used in the second phase of the study. In the second phase, 272 women in the immediate postnatal stage of the maternity and postpartum ward of Taleghani and AL-Zahra Hospitals in Tabriz will be assigned into the intervention (receiving care based on adapted guidline recommendations) and control (receiving routine hospital care) groups uing individual stratified block randomization. At 6 weeks after birth, we will complete the Edinburgh postnatal depression scale, postpartum specific anxiety scale and Barkin index of maternal functioning (to assess the primary outcomes), as well as a maternal health problems checklist, infant care behavior, and violence assessment questionnaires (to asses the seconadary outcomes). Further, the maternal health problems checklist and the Edinburgh postnatal depression scale will be completed in the second week after birth. The data will be analyzed using an independent t-test and ANCOVA. DISCUSSION: It is expected that the implementation of evidence-based clinical guidelines improves maternal and neonatal outcomes and experience of the postpartum period. The positive experience can also help to achieve Iran's population policies and the need to increase childbearing in the country. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N76; Date of registration: 27/1/2023. URL: https://en.irct.ir/user/trial/66874/view ; Date of first registration: 27/3/2023.

The postpartum period, starting immediately after childbirth up to the first six weeks (42 days), is a significant and critical period in the lives of mothers and newborns, spouses, caregivers, and families. Maternal and newborn deaths and complications are high during the postpartum period. Postpartum care with high quality could reduce maternal and newborn deaths and complications, and makes the mother have a positive childbirth experience and a favourable attitude toward her next birth. World Health Organization (WHO) recommend providing medical care and treatment with the highest quality and the least intervention to obtain the best health and well-being conditions for the family. The present study aims to localize and use the international recommendations for the postpartum period in Iran. This study will be done in two phases. In the first phase, the international recommendations for mother and newborn care and postnatal well-being will be adapted according to our country's resources and conditions. In the second phase, the recommendations of adapted guideline will be implemented on 272 mothers and newborn in two groups in the maternity and postpartum ward of Taleghani and AL-zahra Hospitals in Tabriz, and we compare the result of using these recommendations and routine care on mothers' and newborns' well-being. In clinical guideline recommendations group, we will educate mothers, fathers and families and will share with them adapted recommendations, up to 6 weeks after birth and we will support them via the network. During the postpartum period we will assess mental and physical health problems of the mothers; counsel about breastfeeding, baby care, family planning, nutrition, activity, pain killer, bonding and emotional attachment, and prevention of postpartum depression; and any questions will be answered.

Antenatal corticosteroids in specific groups at risk of preterm birth: a systematic review.

OBJECTIVE: This study aimed to synthesise available evidence on the efficacy of antenatal corticosteroid (ACS) therapy among women at risk of imminent preterm birth with pregestational/gestational diabetes, chorioamnionitis or fetal growth restriction (FGR), or planned caesarean section (CS) in the late preterm period. METHODS: A systematic search of MEDLINE, EMBASE, CINAHL, Cochrane Library, Web of Science and Global Index Medicus was conducted for all comparative randomised or non-randomised interventional studies in the four subpopulations on 6 June 2021. Risk of Bias Assessment tool for Non-randomised Studies and the Cochrane Risk of Bias tool were used to assess the risk of bias. Grading of Recommendations Assessment, Development and Evaluations tool assessed the certainty of evidence. RESULTS: Thirty-two studies involving 5018 pregnant women and 10 819 neonates were included. Data on women with diabetes were limited, and evidence on women undergoing planned CS was inconclusive. ACS use was associated with possibly reduced odds of neonatal death (pooled OR: 0.51; 95% CI: 0.31 to 0.85, low certainty), intraventricular haemorrhage (pooled OR: 0.41; 95% CI: 0.23 to 0.72, low certainty) and respiratory distress syndrome (pooled OR: 0.59; 95% CI: 0.45 to 0.77, low certainty) in women with chorioamnionitis. Among women with FGR, the rates of surfactant use (pooled OR: 0.38; 95% CI: 0.23 to 0.62, moderate certainty), mechanical ventilation (pooled OR: 0.42; 95% CI: 0.26 to 0.66, moderate certainty) and oxygen therapy (pooled OR: 0.48; 95% CI: 0.30 to 0.77, moderate certainty) were probably reduced; however, the rate of hypoglycaemia probably increased (pooled OR: 2.06; 95% CI: 1.27 to 3.32, moderate certainty). CONCLUSIONS: There is a paucity of evidence on ACS for women who have diabetes. ACS therapy may have benefits in women with chorioamnionitis and is probably beneficial in FGR. There is limited direct trial evidence on ACS efficacy in women undergoing planned CS in the late preterm period, though the totality of evidence suggests it is probably beneficial. PROSPERO REGISTRATION NUMBER: CRD42021267816.

The Association of Different Proportions of Human Milk of the Total Enteral Intake on Health Outcomes in Preterm Infants: A Systematic Review.

Background: Human milk (HM) is a proven optimal food for preterm infants. However, there is uncertainty regarding the effects of different proportions of HM of the total enteral intake on health outcomes in preterm infants. Therefore, we conducted a systematic review of studies examining the effects of different proportions of HM of the total enteral intake on health outcomes in preterm infants. Methods: We conducted a literature search in the Web of Science, PubMed, and Scopus databases. The methodological quality of the included articles and the certainty of evidence were assessed according to the Newcastle-Ottawa Scale and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool, respectively. Results: Twelve studies were included in the review. Among the clinical findings, the effect of different proportions of HM of the total enteral feeding on health outcomes in preterm infants was divided into six primary outcomes: physical growth, length of stay, morbidity of any disease, all-cause mortality, feeding-related outcomes, and other health outcomes. The studies presented a high risk of bias for most of the domains. The certainty of the evidence was considered low or very low. Conclusions: The findings reiterated that greater proportions of HM positively affect the health outcomes of preterm infants. Overall, when the HM accounts for at least 20% of the total enteral intake, it has an effect on health outcomes in preterm infants. If the proportion of HM reaches 50%, the incidence and severity of necrotizing enterocolitis, as well as the time to reach enteral feeds, will be reduced. Increasing the proportion of HM in enteral feeding should be considered a priority in the feeding strategy for preterm infants in clinical practice.

Neuroprotective effect of magnesium sulfate in premature infants. Analysis after establishing an antenatal administration protocol in a tertiary care hospital.

INTRODUCTION: In 2016, a protocol was developed in our hospital for the antenatal administration of magnesium sulfate in pregnant women at risk of imminent preterm birth as a method to reduce the risk of cerebral palsy (CP). MATERIAL AND METHODS: We conducted a retrospective observational study in a level IIIC hospital with the primary objective of comparing the incidence of CP before and after the implementation of this protocol. Among the secondary outcomes, we ought to highlight the incidence of cognitive deficits and necrotizing enterocolitis and the mortality in both groups. The sample consisted of preterm newborns delivered before 32 weeks of gestation in 2011-2012 (prior to the implementation of the protocol) and in 2016-2018 (after the implementation of the protocol, whose mothers had received magnesium sulfate for neuroprotection). The clinical and epidemiological characteristics of both groups were comparable. RESULTS: We collected data for a total of 523 patients, 263 and 260 in each group. As regards the primary outcome, we did not find statistically significant differences between groups. We observed a statistically significant reduction in mortality and the risk of severe necrotizing enterocolitis in the group of patients born in the 2016-2018 period and between 26+0 and 27+6 weeks of gestation, whose mothers had received magnesium sulfate. CONCLUSIONS: In our study, the administration of magnesium sulfate to mothers at risk of preterm birth did not decrease the risk of developing CP.

Vasopressin versus epinephrine during cardiopulmonary resuscitation of asphyxiated newborns: A study protocol for a prospective, cluster, open label, single-center, randomized controlled phase 2 trial - The VERSE-Trial.

Introduction: Current neonatal resuscitation guidelines recommend the use of epinephrine during neonatal cardiopulmonary resuscitation (CPR). However, newborns receiving epinephrine continue to have high rates of mortality and neurodevelopmental disability. The infrequent need for neonatal CPR, coupled with an inability to consistently anticipate which newborn infants are at risk of requiring CPR, explains the lack of high-quality evidence (i.e., large randomized clinical trials) to better guide healthcare providers in their resuscitative effort. Therefore, we need neonatal data to determine the optimal vasopressor therapy during neonatal CPR. The current pilot trial will examine the efficacy of vasopressin versus epinephrine during CPR of asphyxiated newborn infants. Methods and analysis: The trial will be a prospective, cluster, open label, single-center, randomized controlled trial on two alternative cardiovascular supportive medications. This study will assess the primary outcome of time to return of spontaneous circulation (ROSC) in newborns requiring CPR in the delivery room who were treated with either vasopressin (intervention) or epinephrine (control). Secondary outcomes such as infant mortality and other clinical outcome measures will also be collected. An estimated 20 newborns will be recruited, and comparisons will be made between asphyxiated infants treated with either drugs. Ethics and dissemination: This study has been approved by the Research Ethics Board at the University of Alberta (June 16, 2023). Study findings will be published in peer-reviewed journals, presented at conferences, and communicated to relevant participants and stakeholders.Trial registration: ClinicalTrial.gov Identifier: NCT05738148. Registered February 21, 2023.

[Arterial ischemic stroke in childhood]. / Accidente cerebrovascular isquémico arterial pediátrico.

Despite advances in the identification and recognition of risk factors for pediatric arterial ischemic stroke, little progress has been made in hyperacute treatment. The most frequent risk factors are arteriopathies, cardiopathies, and thrombophilia. Early confirmation with neuroradiological studies is key to consider reperfusion therapies, which have limited evidence in pediatrics but a good safety profile. There is consensus on the use of anticoagulation in cardio-embolic and prothrombotic diseases, and antiplatelet therapy in arteriopathies. The future challenge is to improve coordination between prehospital services and specialized stroke centers to improve therapeutic management in the hyperacute stage and reduce morbidity and mortality.

A pesar de los avances en la identificación y reconocimiento de factores de riesgo del accidente cerebrovascular (ACV) isquémico arterial pediátrico hay escasos avances en el tratamiento hiperagudo. Los factores de riesgo más frecuentes son las arteriopatías, cardiopatías y trombofilias. La confirmación temprana con estudios neurorradiológicos es clave para considerar las terapias de reperfusión, que tienen evidencia limitada en pediatría con buen perfil de seguridad. Existe consenso en la utilización de anticoagulación en patología cardioembólica, enfermedades protrombóticas y antiagregación en arteriopatías. El desafío futuro será lograr una coordinación entre servicios prehospitalarios y centros especializados en ACV, para mejor manejo terapéutico en etapa hiperaguda disminuyendo su morbimortalidad.

Value of brain injury-related indicators based on neural network in the diagnosis of neonatal hypoxic-ischemic encephalopathy.

Neonatal hypoxic ischemic encephalopathy is a common disease, which is caused by fetal hypoxia, asphyxia, and other reasons. It may cause sequelae of the nervous system and even death in children. Computer tomography examination can clarify the scope and location of the disease and provide the basis for clinical treatment and prognosis. Relevant personnel analyzed the symptoms of ischemic hypoxia and found that ischemia and hypoxia were the main causes of encephalopathy. Neonatal ischemia and hypoxia are easy to cause serious damage. At present, with the development of medicine, the function of the human brain is the most important issue in natural science. The law of neural activity and the role of molecular cells, organs, and systems have fundamental construction significance for the prevention and treatment of nerve and mental diseases. By analyzing the value of the diagnosis of neonatal hypoxic-ischemic encephalopathy in the analysis of experimental data, by setting the newborns in the controlled group and the trial group as experimental subjects, this paper analyzed the situation of newborns in terms of body temperature, body weight, and respiratory rate, and used Apgar score to score these standards. It was found that the score of the controlled group was 7 and above, and the score of the trial group was below 7. It was found that the Apgar scoring method was more simple. Then, the newborns were analyzed by cord blood gas analysis. It was found that most of the data in the control group were between 7.8 and 8.4, and the data in the trial group were between 5.8 and 7.1. The umbilical blood gas analysis score of the experimental group was lower than that of the control group. By comparing the satisfaction of cord blood gas analysis and the Apgar score, it was found that the satisfaction of cord blood gas analysis was 24.06% higher than that of the Apgar score.

MRI pulmonary artery flow detects lung vascular pathology in preterms with lung disease.

RATIONALE: Pulmonary vascular disease (PVD) affects the majority of preterm neonates with bronchopulmonary dysplasia (BPD) and significantly determines long-term mortality through undetected progression into pulmonary hypertension. OBJECTIVES: To associate characteristics of pulmonary artery (PA) flow and cardiac function with BPD-associated PVD near term using advanced magnetic resonance imaging (MRI) for improved risk stratification. METHODS: Preterms <32 weeks postmenstrual age (PMA) with/without BPD were clinically monitored including standard echocardiography and prospectively enrolled for 3TMRI in spontaneous sleep near term (AIRR study). Semi-manual PA flow quantification (phase-contrast MRI, no BPD n=28, mild n=35, moderate/severe n=25) was complemented by cardiac function assessment (cine MRI). MEASUREMENTS AND MAIN RESULTS: We identified abnormalities in PA flow and cardiac function, i.e. increased net forward volume (ratio right-over-left), decreased mean relative area change and pathologic right end-diastolic volume to sensitively detect BPD-associated PVD while correcting for PMA (L1OAUC=0.88/sensitivity=0.80/specificity=0.81). We linked these changes to increased right ventricular (RV) afterload (RV-arterial coupling (p=0.02), PA midsystolic notching (p=0.015(t2)), cardiac index (p=1.67×10-8)) and correlated echocardiographic findings. Identified in moderate/severe BPD, we successfully applied the PA flow model in heterogeneous mild BPD cases, demonstrating strong correlation of PVD probability with indicators of BPD severity, i.e., duration of mechanical ventilation (R=0.62, p=3.7×10-4) and oxygen supplementation (R=0.58, p=9.2×10-4). CONCLUSIONS: Abnormalities in MRI PA flow and cardiac function exhibit significant, synergistic potential to detect BPD-associated PVD, advancing the possibilities of risk-adapted monitoring.

Advancement in biomarker based effective diagnosis of neonatal sepsis.

Neonatal sepsis is considered as alarming medical emergency and becomes the common global reason of neonatal mortality. Non-specific symptoms and limitations of conventional diagnostic methods for neonatal sepsis mandate fast and reliable method to diagnose disease for point of care application. Recently, disease specific biomarkers have gained interest for rapid diagnosis that led to the development of electrochemical biosensor with enhanced specificity, sensitivity, cost-effectiveness and user-friendliness. Other than conventional biomarker C-reactive protein to diagnose neonatal sepsis, several potential biomarkers including Procalcitonin (PCT), Serum amyloid A (SAA) and other candidates are extensively investigated. The present review provides insights on advancements and diagnostic abilities of protein and nucleotide based biomarkers with their incorporation in developing electrochemical biosensors by employing novel fabrication strategies. This review provides an overview of most promising biomarker and its capability for neonatal sepsis diagnosis to fulfil future demand to develop electrochemical biosensor for point-of-care applications.