Resuscitation with Intact Cord Versus Clamped Cord in Late Preterm and Term Neonates: A Randomized Controlled Trial.

OBJECTIVE: To compare the effect of intact cord versus clamped cord resuscitation on the physiologic transition of neonates receiving positive-pressure ventilation (PPV) at birth. STUDY DESIGN: This open-label, parallel-group, randomized controlled superiority trial was conducted in a tertiary care hospital in India. Neonates born at ≥34 weeks of gestation after a complicated pregnancy or labor were randomized just before birth to receive resuscitation according to the Neonatal Resuscitation Program algorithm with either an intact cord (intact cord resuscitation group) or after early cord clamping (early cord clamping resuscitation group). The allocated study intervention was administered if the neonate needed PPV at birth. The primary outcome was expanded Apgar score at 5 minutes after birth. RESULTS: Birth weight, gestational age, and the incidence of pregnancy complications were similar in the 2 study groups. The proportion of neonates who received PPV was lower in the intact cord resuscitation group (28.7% vs 36.5%, P = .05; relative risk, 0.79; 95% CI, 0.61-1.01). Among neonates who received PPV, the expanded Apgar score at 5 minutes was significantly higher in the intact cord resuscitation group (median, 15 [IQR, 14-15] vs 14 [IQR, 13-15]; P < .001). The expanded Apgar score at 10 minutes, Apgar scores at 5 and 10 minutes, and oxygen saturation at 1, 5, and 10 minutes were also higher in the intact cord resuscitation group. CONCLUSION: In late preterm and term neonates, resuscitation with an intact cord results in better postnatal physiologic transition than the standard practice of resuscitation after immediate cord clamping. TRIAL REGISTRATION: Clinical Trial Registry of India (www.ctri.nic.in); trial registration no. CTRI/2020/02/023379.

Population pharmacokinetics of ciprofloxacin in newborns with early onset neonatal sepsis and suspected meningitis.

BACKGROUND: Neonatal Sepsis accounts for significant proportion of neonatal mortality globally. Ciprofloxacin can be used as an effective antimicrobial against common causative agents of neonatal sepsis. However, there is only limited information about its pharmacokinetic distribution in plasma and Cerebrospinal fluid (CSF) of neonates. METHODS: Plasma and CSF samples were taken using a sparse sampling technique from neonates who received at least one dose of intravenous ciprofloxacin. Ciprofloxacin levels were analysed using high-performance liquid chromatography (HPLC). Population pharmacokinetic analysis was conducted using a non-linear mixed-effects modelling using Pumas® (Pharmaceutical Modelling and Simulation) package (Version 2.0). RESULTS: 53 neonates were enroled in the study of whom; 9 (17%) had meningitis. The median concentration of ciprofloxacin in CSF was 1.4 (0.94-2.06) ug/ml and plasma was 2.94 (1.8-5.0) ug/ml. A one-compartment model with first-order elimination fitted the data. Body weight was found to be a significant covariate on volume of distribution (Vd). Simulations based on the final model suggest that dose of 10 mg/kg, intravenous b.d may not be able to achieve the desirable indices. CONCLUSIONS: One compartment model with weight as a covariate explained the available data. Further studies with modified sampling strategy, larger sample size and variable dose levels are needed.

Closed versus open endotracheal tube suction in mechanically ventilated neonates: a randomized controlled trial.

This study aimed to evaluate the effect of closed versus open endotracheal tube suction in reducing ventilator-associated pneumonia in mechanically ventilated neonates. In this open-label, parallel-group, randomized controlled trial with allocation concealment, ventilated neonates (≥ 28 weeks and ≥ 800 g) were either allocated to the closed-suction group (n = 41) or open-suction group (n = 39). The ventilator circuit of the babies enrolled in the closed-suction group was attached to the closed-suction catheter on the requirement of their first suction, and it was changed after every 48 h or earlier if visibly soiled whereas babies enrolled in the open-suction group were suctioned with a new suction catheter each time they require suction. The primary outcome was the incidence of VAP per 1000 days. Baseline maternal and neonatal characteristics were comparable between the two groups. The proportion of neonates with VAP in the closed-suction group was 3 (7.3%) and 1 (2.6%) in the open-suction group with an RR of 2.8 (95% CI: 0.30-26.28) and a p-value of 0.35. The incidence of VAP in the closed-suction group was 3.9 per 1000 ventilator days and 1.3 per 1000 ventilator days in the open-suction group. The incidence of clinical VAP/1000 ventilator days was 33.63 ± 22.96 in the closed-suction group and 28.67 ± 12.32 in the open-suction group with a mean difference of 5 (95% CI: - 3.26 to 13.26) and p-value of 0.24. CONCLUSION: In a unit with a low incidence of VAP, the effect of the endotracheal suction method alone did not impact the occurrence of VAP in the study population. CLINICAL TRIAL REGISTRATION: CTRI/2020/03/023679; Date: 17.02.2020. WHAT IS KNOWN: • Better physiological stability of the closed-suctioning method on short-term measures including noticeably fewer episodes of hypoxia, a smaller drop in TcPO2 levels, and less variability in heart rate and bradycardia episodes. WHAT IS NEW: • In a unit with a low incidence of VAP in the neonates, randomized control trial studying the effect of the endotracheal suction method alone did not impact the occurrence of VAP amongst the study population.

Supplementation of mother's own milk with term versus preterm donor human milk: a randomized controlled trial.

The purpose of this is to evaluate the effect of supplementation of enteral feed volume with preterm versus term donor human milk (DHM) on short-term physical growth in very low birth weight (VLBW) neonates. In this open-label, variable block-sized, superiority, randomized controlled trial with allocation concealment, VLBW neonates with insufficient volume of mother's own milk (MOM) were assigned to receive either preterm (n = 48) or term (n = 54) DHM till discharge. Preterm DHM was defined as the breast milk expressed within 28 days of delivery at ≤ 34 weeks of gestation. The primary outcome was days to regain birth weight. Maternal and neonatal demographic variables were comparable in the two study groups. Days to regain birth weight were significantly more in the preterm DHM group, 17.4 (7.7) vs 13.6 (7.2) days, mean difference (95% CI) being 3.74 (0.48-7.0) days, P = 0.02). The proportion of MOM use was 82% in preterm vs 91.1%, P = 0.03 in the term milk group. Duration of skin-to-skin contact was also significantly lower in the preterm vs term milk group, the median (IQR) was 4 (0, 6) vs 4 (2, 6) hours/day, P < 0.01. However, bronchopulmonary dysplasia was higher in the preterm milk group (13% vs. 4%, P = 0.17). The velocity of gain in weight was similar in the two groups from week 1-3 but higher in the term DHM supplementation group during the 4th week. Conclusion: Supplementing MOM with preterm DHM did not result in a faster regaining of birth weight. Trial registration: CTRI/2020/02/023569; Date: 17.02.2020.

Non-contact respiratory rate monitoring using thermal and visible imaging: a pilot study on neonates.

Respiratory rate (RR) monitoring is essential in neonatal intensive care units. Despite its importance, RR is still monitored intermittently by manual counting instead of continuous monitoring due to the risk of skin damage with prolonged use of contact electrodes in preterm neonates and false signals due to displacement of electrodes. Thermal imaging has recently gained significance as a non-contact method for RR detection because of its many advantages. However, due to the lack of information in thermal images, the selection and tracking of the region of interest (ROI) in thermal images for neonates are challenging. This paper presents the integration of visible (RGB) and thermal (T) image sequences for the selection and tracking of ROI for breathing rate extraction. The deep-learning based tracking-by-detection approach is employed to detect the ROI in the RGB images, and it is mapped to the thermal images using the RGB-T image registration. The mapped ROI in thermal spectrum sequences gives the respiratory rate. The study was conducted first on healthy adults in different modes, including steady, motion, talking, and variable respiratory order. Subsequently, the method is tested on neonates in a clinical settings. The findings have been validated with a contact-based reference method.The average absolute error between the proposed and belt-based contact method in healthy adults reached 0.1 bpm and for more challenging conditions was approximately 1.5 bpm and 1.8 bpm, respectively. In the case of neonates, the average error is 1.5 bpm, which are promising results. The Bland-Altman analysis showed a good agreement of estimated RR with the reference method RR and this pilot study provided the evidence of using the proposed approach as a contactless method for the respiratory rate detection of neonates in clinical settings.

Systemic biomarkers of retinopathy of prematurity in preterm babies.

PURPOSE: Retinopathy of prematurity (ROP) progression is an inter-play of various perinatal and neonatal angiogenic and inflammatory cytokines. A small subset of ROP progresses to ROP requiring treatment. The present study was conducted with the aim to determine whether levels of IL-6, IL-8 and VEGF in serum and urine at the time of first ROP screening visit could be a biomarker for the prediction of development of treatable ROP. METHOD: Prospective single-center observational study of preterm babies screened for ROP. Blood and urine samples were collected as a part of routine sampling at initial ROP screening visit and stored at -80 °C for further processing. The babies were followed up and grouped into 'Group A' comprising of 35 babies who developed treatable ROP and 'Group B' comprising of 36 babies with regressed ROP or no ROP. The evaluation of blood and urine samples was done for IL6, IL8 and VEGF by solid-phase sandwich RayBio® Human ELISA kit. RESULTS: The median serum values for IL-6, IL-8 and VEGF in Group A and Group B were 5.8 pg/ml (IQR 1.5,128.5) and 8.7 pg/ml (IQR 1.5,30.5), 55.9 pg/ml (IQR 28.0, 392.9) and 27.0 pg/ml (IQR 20.5,444.9) and 26.6 pg/ml (IQR 6.3, 39.4) and 30.0 pg/ml (IQR9.2,70.3), respectively. Group A had significantly increased levels of IL-8 (p < 0.05). However, AUROC curve for serum IL-8 demonstrated suboptimal discriminating ability. CONCLUSION: Babies developing ROP requiring treatment had significantly increased levels of IL-8 in the serum at the time of initial screening. However, it could not serve as predictor for treatable ROP.

Impact of mother-baby friendly initiative plus approach on improving human milk feeding for neonates in hospital: a quality improvement before-and-after uncontrolled study.

Breastfeeding, use of pasteurised donor human milk when mother's own milk is unavailable and kangaroo mother care have independently proven benefits in improving survival of vulnerable sick babies. A triangulated approach called the Mother Baby Friendly Initiative Plus (MBFI+) model, bringing together the combined benefits of these proven interventions, was used to improve exclusive human milk feeding at health facilities through quality improvement and system strengthening approach. This quality improvement before-and-after uncontrolled study enrolled 5343 term and 278 very low birth weight (VLBW) mother-infant dyads. Pre- and post-intervention data were compared to evaluate effect on feeding-related healthcare processes and outcomes. Primary outcome which was incidence of exclusive human milk feeding during hospital stay, improved from 44 to 64.8% (RR 1.47, 95% CI: 1.40-1.55) among term and from 60.5 to 80.7% (RR: 1.33; 95% CI: 1.12-1.59) among VLBW neonates. Neonates receiving extended KMC improved from 43 to 71.1% (RR: 1.65; 95% CI: 1.30-2.10).Conclusion: MBFI+ approach improved exclusive human milk feeding among term and preterm VLBW neonates. What is Known: • Breastfeeding has immense health benefits to sick preterm neonates admitted in NICU. What is New: • Quality improvement approach can lead to system strengthening and can help overcome hindrances to achieve increased breastfeeding rates.

Periodic change of body position under phototherapy in term and preterm neonates with hyperbilirubinaemia.

BACKGROUND: Phototherapy is the mainstay of treatment of neonatal hyperbilirubinaemia. Periodic change in position of the neonate under phototherapy (from supine to prone or lateral positions) may improve the efficiency of phototherapy by hastening the access of phototherapy light to bilirubin deposited in different parts of the skin and subcutaneous tissue. OBJECTIVES: To evaluate the effects of periodic change of body position during phototherapy as compared to no prescribed change in body position, on serum total bilirubin level and duration of treatment in neonates with unconjugated hyperbilirubinaemia during the first 28 days of life. Secondary objectives of the review included evaluation of the efficacy of periodic change of body position on the need for or number of exchange transfusions, incidence of bilirubin-induced neurological damage (BIND), side effects of phototherapy, and sudden infant death syndrome (SIDS). SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to run comprehensive searches in the Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 3) in the Cochrane Library and Ovid MEDLINE and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions on 5 March 2021. We also searched clinical trials databases and the reference lists of included studies and relevant reviews for randomised controlled trials (RCTs) and quasi-RCTs. SELECTION CRITERIA: We included RCTs and quasi-RCTs if they enrolled neonates (term and preterm) of either gender with unconjugated hyperbilirubinaemia requiring phototherapy and compared periodic change of the body position of the infant under phototherapy with no prescribed change in body position. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data, consulting with a third review author in the case of disagreement. We used standard Cochrane methodological procedures, including assessing the risk of bias of included studies. We used the GRADE approach to assess the certainty of evidence. Primary outcomes were the duration of phototherapy and rate of fall of serum bilirubin at 24 hours. Secondary outcomes included the need for exchange transfusion, number of exchange transfusions, incidence of BIND, and SIDS. MAIN RESULTS: We included five studies (343 neonates) with an overall high risk of bias in the review. The body position under phototherapy was changed every two hours or every two-and-a-half hours in two studies each, and every three hours in one study. Three of the five studies included healthy term neonates, whilst the other two studies also included preterm neonates (≥ 33 weeks' gestation); however, separate data about review outcomes in preterm neonates were not available. Periodic change in body position may lead to little or no difference in the duration of phototherapy (mean difference (MD) 1.71 hours, 95% confidence interval (CI) -3.17 to 6.59 hours; I² = 58%; 4 studies, 231 participants; low certainty evidence). Only one study reported the rate of fall of serum total bilirubin at 24 hours of starting the phototherapy. Periodic change in body position may lead to little or no difference in the rate of fall of serum total bilirubin at 24 hours (MD 0.02 mg/dL/h, 95% CI -0.02 to 0.06 mg/dL/h; 1 study, 100 participants; low certainty evidence). We downgraded the certainty of evidence to low due to risk of bias and imprecision. None of the included studies reported the need for or number of exchange transfusions, incidence of BIND, or SIDS. Lack of separate data precluded subgroup analysis. AUTHORS' CONCLUSIONS: The available evidence is insufficient to determine the effects of periodic change of body position compared with no prescribed change of body position under phototherapy. There is low certainty evidence that there may be little or no difference in the duration of phototherapy and rate of fall in bilirubin at 24 hours of starting phototherapy between periodic change in body position and no prescribed change of body position under phototherapy in term and preterm neonates. None of the included studies reported the effect of change of position on the need for or number of exchange transfusions, incidence of BIND, or SIDS. One study is awaiting classification and could not be included in the review. Further studies are needed to evaluate the effect of periodic change in body position under phototherapy, especially in neonates with haemolytic hyperbilirubinaemia and in very preterm neonates. The results of this systematic review apply mainly to neonates born at late-preterm or term gestation receiving phototherapy for non-haemolytic hyperbilirubinaemia.

Peripheral Perfusion Index as a Marker of Sepsis in Preterm Neonates.

BACKGROUND: Neonatal sepsis is a major contributor to neonatal mortality in India. Blood culture, the gold standard for the diagnosis of sepsis takes 48-72 h while the serological markers have suboptimal diagnostic test characteristics. Perfusion index (PI) is a real time, non-invasive marker that can detect microcirculatory changes before other clinical manifestation of sepsis. OBJECTIVE: To determine the diagnostic accuracy of PI in detecting hospital-acquired sepsis before overt clinical manifestations. STUDY DESIGN: A prospective observational study conducted in the Neonatal Intensive Care Unit (NICU) of a tertiary care hospital. PARTICIPANTS: Preterm neonates admitted to NICU. METHODS: PI was continuously monitored in all enrolled neonates. Clinical sepsis was defined using the NeonatalKrankenhaus-Infektions-Surveillance-System (NeoKISS). The time of fall of PI below 0.88 and time of clinical sepsis as per NeoKISS were noted and the difference was calculated. RESULTS: Among 65 preterm neonates (gestational age: 31.5 ± 2.6 weeks, birth weight: 1350, IQR 1100-1700 g), a total of 86 events of suspected sepsis were noted, of which 69 were sepsis screen positive. Fifteen events were associated with culture positive sepsis. PI yielded a sensitivity of 89.47% (95% CI 78.48-96.04%), specificity of 56% (95% CI 34.93-75.60%), positive predictive value of 82.26% (95% CI 74.70-87.92%) and negative predictive value of 70% (95% CI 50.36-84.29%) in detection of hospital-acquired sepsis. CONCLUSION: PI might serve as an early, non-invasive marker of hospital-acquired sepsis in preterm neonates.

Evaluation of double lung point sign as a marker for transient tachypnoea of the newborn in preterm.

Purpose: The study was conducted to diagnose transient tachypnoea of the newborn (TTN) in the early stage using ultrasonography and to estimate the sensitivity and specificity of double lung point (DLP) sign in diagnosing TTN. Material and methods: The study population included premature neonates with respiratory distress, admitted in the neonatal intensive care unit from December 2017 to June 2019, who fulfilled the inclusion criteria. A total of 100 patients were included in the study, and they underwent lung ultrasonography within 6 hours of birth. Inclusion criteria were as follows: preterm babies born < 37 weeks of gestation presenting with respiratory distress within 6 hours, clinically diagnosed with TTN and other causes like respiratory distress syndrome and pneumonia. Term neonates and neonates with congenital malformations and trauma were excluded from the study. Preterms with respiratory distress were enrolled in the study. Based on the clinical findings and laboratory investigations, clinical diagnosis was made by the paediatrician. After obtaining informed consent, ultrasonography of bilateral chest was performed using a Philips HD7 XE and a Sonoscape S2 portable ultrasound machine with a linear transducer (6-12 MHz) within 6 hours of birth. Results: The mean gestational age was 33.0 ± 1.9 weeks. Double lung point sign was present in 55 preterm neonates in our study. It was most common in bilateral posterior lung fields. The sensitivity and specificity of DLP in diagnosing TTN was 85% and 100%, respectively. Conclusions: It was found in our study that double lung point sign is the primary ultrasonographic characteristic of TTN, and ultrasonography can almost accurately diagnose TTN in early stages.

Effect of fetal growth restriction on urinary podocalyxin levels at birth in preterm neonates.

BACKGROUND: Small-for-gestational-age (SGA) neonates are at a higher risk of adult-onset metabolic disorders because of fetal programming in the presence of growth restriction. Nephrogenesis may also be affected in fetal growth restriction. This study hypothesized that urinary podocalyxin levels, a marker of nephrogenesis, would be lower among preterm SGA neonates as compared to appropriate-for-gestational-age (AGA) controls. METHODS: This cross-sectional study enrolled gestation-matched SGA (n = 90) and AGA (n = 45) neonates born at 260-366 weeks of gestation. The SGA group comprised of 45 neonates with birth weight between 3rd and 10th centile and 45 neonates with birth weight <3rd centile. The primary outcome of the study was the difference in urinary podocalyxin levels between SGA and AGA neonates. Glomerular and tubular functions were also assessed. RESULTS: Urinary podocalyxin levels were similar in SGA and AGA neonates (ng/mg of creatinine; median [interquartile range]: 28.7 [4.8-70.2] vs. 18.7 [3.1-55.9]), P value 0.14). No correlation was observed between birth weight centile and urinary podocalyxin levels (r: -0.06). Glomerular filtration rate, fractional excretion of sodium, and serum ß-2-microglobulin levels were comparable across the study groups. CONCLUSIONS: Glomerular development as assessed by urinary podocalyxin levels and renal functions are comparable in SGA and AGA preterm neonates. IMPACT: Neonates born with fetal growth restriction are at a higher risk of adult-onset metabolic disorders because of fetal programming. This cross-sectional study investigated the effect of presence and severity of fetal growth restriction on glomerular development by measuring urinary podocalyxin levels in preterm infants. This study did not observe any effect of the presence or severity of fetal growth restriction on urinary podocalyxin levels and other markers of glomerular and renal tubular functions.

Chest shielding in preterm neonates under phototherapy-a randomised control trial.

Shielding the precordium can effect manifestation of haemodynamically significant patent ductus arteriosus (hsPDA). Preterm neonates born at ≤ 32 weeks of gestation if needed phototherapy within 72 h of birth and had no echocardiographically proven hsPDA were eligible to be enrolled in this open-label randomised controlled trial. In chest shielding group, in addition to the standard care, left side of the chest was covered using food grade aluminium foil during phototherapy while control group received standard care. Mean gestational age (weeks; 30.1 ± 1.5 vs 30.1 ± 1.6) was comparable in the two groups. However, neonates in the chest shield group had lower birth weight (g; 1281 ± 259 vs 1422 ± 307) and were more likely to be small-for-gestational age (21.6% vs 8.0%). It was seen that 4 (7.8%) babies in the chest shield group and 5 (10%) babies in the standard group developed hsPDA after starting phototherapy with relative risk (RR) of 0.78 (95% CI 0.22-2.75). The left atrium to aortic ratio was significantly different in the two groups with 1.5 ± 0.1 in the chest shield group and 1.8 ± 0.2 in standard group (p value 0.03).Conclusion: Chest shielding of preterm babies during phototherapy has no effect on the incidence of haemodynamically significant patent ductus arteriosus.Trial registration: Trial was registered with Clinical trial registry of India (CTRI/2018/01/011069). What is Known: • Chest shielding in preterm neonates under phototherapy has inconclusive effect on the manifestation of patent ductus arteriosus. What is New: • Preterm neonates under phototherapy have no significant difference in manifestation of haemodynamically significant patent ductus arteriosus if precordium is shielded.

Tracheal suction at birth in non-vigorous neonates born through meconium-stained amniotic fluid.

BACKGROUND: Neonates born through meconium-stained amniotic fluid (MSAF) are at risk of developing meconium aspiration syndrome (MAS). Neonates who are non-vigorous due to intrapartum asphyxia are at higher risk of developing MAS. Clearance of meconium from the airways below the vocal cords by tracheal suction before initiating other steps of resuscitation may reduce the risk of development of MAS. However, conducting tracheal suction may not only be ineffective, it may also delay effective resuscitation, thus prolonging and worsening the hypoxic-ischaemic insult.  OBJECTIVES: To evaluate the efficacy of tracheal suctioning at birth in preventing meconium aspiration syndrome and other complications among non-vigorous neonates born through meconium-stained amniotic fluid. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL 2020, Issue 11) in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R) (1946 to 25 November 2020) for randomised controlled trials (RCTs) and quasi-randomised trials. We also searched clinical trials databases and the reference lists of retrieved articles for RCTs and quasi-randomised trials (up to November 2020). SELECTION CRITERIA: We included studies enrolling non-vigorous neonates born through MSAF, if the intervention being tested included tracheal suction at the time of birth with an intent to clear the trachea of meconium before regular breathing efforts began. Tracheal suction could be performed with an endotracheal tube or a wide-gauge suction catheter. Neonates in the control group should have been resuscitated at birth with no effort made to clear the trachea of meconium. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data, consulting with a third review author about any disagreements. We used standard Cochrane methodological procedures, including assessment of risk of bias for all studies. Our primary outcomes were: MAS; all-cause neonatal mortality; and incidence of hypoxic-ischaemic encephalopathy (HIE). Secondary outcomes included: need for mechanical ventilation; incidence of pulmonary air leaks; culture-positive sepsis; and persistent pulmonary hypertension. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS: We included four studies (enrolling 581 neonates) in the review. All four studies were conducted in tertiary care hospitals in India. Three of the four studies included neonates born at and beyond term gestation, whereas one included neonates born at and beyond 34 weeks of gestation. Due to the nature of the intervention, it was not possible to blind the healthcare personnel conducting the intervention. Tracheal suction compared to no suction in non-vigorous neonates born through MSAF In non-vigorous infants, no differences were noted in the risks of MAS (RR 1.00, 95% CI 0.80 to 1.25; RD 0.00, 95% CI -0.07 to 0.08; 4 studies, 581 neonates) or all-cause neonatal mortality (RR 1.24, 95% CI 0.76 to 2.02; RD 0.02, 95% CI -0.03 to 0.07; 4 studies, 575 neonates) with or without tracheal suctioning. No differences were reported in the risk of any severity HIE (RR 1.05, 95% CI 0.68 to 1.63; 1 study, 175 neonates) or moderate to severe HIE (RR 0.68, 95% CI 0.43 to 1.09; 1 study, 152 neonates) among non-vigorous neonates born through MSAF. We are also uncertain as to the effect of tracheal suction on other outcomes such as incidence of mechanical ventilation (RR 0.99, 95% CI 0.68 to 1.44; RD 0.00, 95% CI -0.06 to 0.06; 4 studies, 581 neonates), pulmonary air leaks (RR 1.22, 95% CI 0.38 to 3.93; RD 0.00, 95% CI -0.02 to 0.03; 3 studies, 449 neonates), persistent pulmonary hypertension (RR 1.29, 95% CI 0.60 to 2.77; RD 0.02, 95% CI -0.03 to 0.06; 3 studies, 406 neonates) and culture-positive sepsis (RR 1.32, 95% CI 0.48 to 3.57; RD 0.01, 95% CI -0.03 to 0.05; 3 studies, 406 neonates). All reported outcomes were judged as providing very low certainty evidence. AUTHORS' CONCLUSIONS: We are uncertain about the effect of tracheal suction on the incidence of MAS and its complications among non-vigorous neonates born through MSAF. One study awaits classification and could not be included in the review. More research from well-conducted large trials is needed to conclusively answer the review question.

Fluid restriction in the management of transient tachypnea of the newborn.

BACKGROUND: Transient tachypnea of the newborn (TTN) is caused by delayed clearance of lung fluid at birth. TTN typically appears within the first two hours of life in term and late preterm neonates and is characterized by tachypnea and signs of respiratory distress. Although it is usually a self-limited condition, admission to a neonatal unit is frequently required for monitoring and providing respiratory support. Restricting intake of fluids administered to these infants in the first days of life might improve clearance of lung liquid, thus reducing the effort required to breathe, improving respiratory distress, and potentially reducing the duration of tachypnea. OBJECTIVES: To evaluate the efficacy and safety of restricted fluid therapy as compared to standard fluid therapy in decreasing the duration of oxygen administration and the need for noninvasive or invasive ventilation among neonates with TTN. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 12), in the Cochrane Library; Ovid MEDLINE and electronic ahead of print publications, in-process & other non-indexed citations, Daily and Versions(R); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), on December 6, 2019. We also searched clinical trial databases and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials. SELECTION CRITERIA: We included randomized controlled trials (RCTs), quasi-RCTs, and cluster trials on fluid restriction in term and preterm neonates with the diagnosis of TTN or delayed adaptation during the first week after birth. DATA COLLECTION AND ANALYSIS: For each of the included trials, two review authors independently extracted data (e.g. number of participants, birth weight, gestational age, duration of oxygen therapy, need for continuous positive airway pressure [CPAP], need for mechanical ventilation, duration of mechanical ventilation) and assessed the risk of bias (e.g. adequacy of randomization, blinding, completeness of follow-up). The primary outcome considered in this review was the duration of supplemental oxygen therapy in hours or days. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS: Four trials enrolling 317 infants met the inclusion criteria. Three trials enrolled late preterm and term infants with TTN, and the fourth trial enrolled only term infants with TTN. Infants were on various methods of respiratory support at the time of enrollment including room air, oxygen, or nasal CPAP. Infants in the fluid-restricted group received 15 to 20 mL/kg/d less fluid than those in the control group for varying durations after enrollment. Two studies had high risk of selection bias, and three out of four had high risk of performance bias. Only one study had low risk of detection bias, with two at high risk and one at unclear risk. The certainty of evidence for all outcomes was very low due to imprecision of estimates and unclear risk of bias. Two trials reported the primary duration of supplemental oxygen therapy. We are uncertain whether fluid restriction decreases or increases the duration of supplemental oxygen therapy (mean difference [MD] -12.95 hours, 95% confidence interval [CI] -32.82 to 6.92; I² = 98%; 172 infants). Similarly, there is uncertainty for various secondary outcomes including incidence of hypernatremia (serum sodium > 145 mEq/L, risk ratio [RR] 4.0, 95% CI 0.46 to 34.54; test of heterogeneity not applicable; 1 trial, 100 infants), hypoglycemia (blood glucose < 40 mg/dL, RR 1.0, 95% CI 0.15 to 6.82; test of heterogeneity not applicable; 2 trials, 164 infants), endotracheal ventilation (RR 0.73, 95% CI 0.24 to 2.23; I² = 0%; 3 trials, 242 infants), need for noninvasive ventilation (RR 0.40, 95% CI 0.14 to 1.17; test of heterogeneity not applicable; 2 trials, 150 infants), length of hospital stay (MD -0.92 days, 95% CI -1.53 to -0.31; test of heterogeneity not applicable; 1 trial, 80 infants), and cumulative weight loss at 72 hours of age (%) (MD 0.24, 95% CI -1.60 to 2.08; I² = 89%; 2 trials, 156 infants). We did not identify any ongoing trials; however, one trial is awaiting classification. AUTHORS' CONCLUSIONS: We found limited evidence to establish the benefits and harms of fluid restriction in the management of TTN. Given the very low certainty of available evidence, it is impossible to determine whether fluid restriction is safe or effective for management of TTN. However, given the simplicity of the intervention, a well-designed trial is justified.

Predictors of length of hospital stay among preterm infants admitted to neonatal intensive care unit: Data from a multicentre collaborative network from India (INNC: Indian National Neonatal Collaborative).

AIM: Prediction of length of stay (LOS) among preterm neonates is important for counselling of parents and for assessing neonatal intensive care unit (NICU) census and economic burden. The aim of this study is to evaluate perinatal and postnatal factors that influence LOS in preterm infants (25-33 weeks of gestation) admitted to participating NICUs of Indian National Neonatal Collaborative (INNC). METHODS: From the INNC database, the data which were prospectively entered using uniformed pre-defined criteria were analysed. RESULTS: A total of 3095 infants were included from 12 centres. Every week decrease in gestation increased LOS by 9 days. The median LOS for infants with gestational age of 25, 26, 27, 28, 29, 30, 31, 32 and 33 weeks were 86, 70, 62, 52, 40, 30, 23, 16 and 10 days, respectively. On multivariate analysis, abnormal antenatal umbilical artery doppler, severe small for gestational age (SGA), requirement of resuscitation, respiratory distress syndrome (RDS), seizures, sepsis, necrotising enterocolitis (NEC), major malformations and bronchopulmonary dysplasia (BPD) increased LOS by 5.4 (3.5-7.4), 21.6 (19-23.9), 4.7 (3.3-6.1), 3 (1.7-4.3), 15.2 (8.5-22.1), 11.2 (9.1-13.2), 9.8 (5.2-14.4), 8.8 (4.4-13.3) and 5.6 (0.5-10.7) days, respectively. CONCLUSIONS: Apart from lower gestation and birth weight, abnormal antenatal umbilical artery doppler, severe SGA, resuscitation need, major malformations, RDS, seizures, sepsis, NEC and BPD influenced LOS in preterm infants. In comparison with other networks or data from developed countries, LOS in our network was comparatively less for similar gestational age infants.

Accuracy of New Ballard Score in Small-for-gestational Age Neonates.

OBJECTIVE: The aim of this study was to evaluate the performance of New Ballard Score (NBS) in small-for-gestational age (SGA) neonates. METHODOLOGY: Neonates born at 35-40 weeks of gestation were included if accurate obstetric gestation estimate was available and birth weight was <10th percentile for gestation. Gestation-matched appropriate-for-gestational-age neonates were enrolled as controls. Gestation derived from NBS was compared with gestation calculated from last menstrual period. RESULTS: Gestational age estimated by NBS was significantly higher in SGA neonates (mean difference: 0.7 weeks). Neuromuscular component score was similar but physical component score was significantly higher in SGA neonates. Reanalysis after reducing score of 4 to 3 of SGA babies for skin and plantar crease physical parameters showed overestimation of gestational age decreased to 0.4 weeks. CONCLUSIONS: The physical parameters of NBS overestimate gestation in SGA neonates. Changing scores of skin and plantar creases in SGA neonates better estimates gestation age.

Validity of non-invasive point-of-care hemoglobin estimation in healthy and sick children-a method comparison study.

This study was conducted at a tertiary care center in northern India to evaluate the validity of non-invasive transcutaneous hemoglobin estimation in healthy and sick children in comparison to hemoglobin estimation by traditional lab method. A method comparison study was conducted including 150 subjects. Enrolled patients included 80 neonates with average age of 3.9 ± 2.1 days, and 70 children with average age of 5.8 ± 2 years. Each population (newborn and children) comprised of almost equal numbers of healthy and critically ill patients with shock. Hemoglobin (Hb) was estimated on enrolment by transcutaneous spectrophotometry (SpHb) and traditional automated lab analyzer (Hb-Lab). Difference between Hb levels by the two methods (called bias) was measured and analyzed using Bland-Altman method. Out of 148 data pairs analyzed, bias between SpHb and Hb-Lab was -1.52 ± 1.91 g/dl (mean ± SD). SpHb showed excellent positive correlation with Hb-Lab (r = 0.94 (p < 0.001)) and good visual agreement on Bland-Altman plots. Bias was higher in sick subjects with shock as compared to healthy ones in both neonatal and pediatric population (-2.31 ± 2.21 g/dl versus -0.77 ± 1.2 g/dl, respectively). CONCLUSIONS: SpHb showed good accuracy and correlated well with lab estimated Hb levels in healthy children. However, in children with impaired peripheral perfusion, its diagnostic accuracy was inadequate to justify routine use for quantification of severity of anemia and making transfusion decisions solely on non-invasive estimation of hemoglobin. WHAT IS KNOWN: Non-invasive hemoglobin estimation is a relatively new and novel method which has given mixed results regarding its potential efficacy in adults. There is limited data regarding usefulness and accuracy of non-invasive Hb estimation by SpHb in sick neonates and children. WHAT IS NEW: Non-invasive Hb estimation by SpHb monitor is reasonably accurate in healthy neonates and children. It can be used in critically ill children and neonates, but in conjunction with lab confirmation of Hb values.

Clinical predictors of hospital admission in acute lower respiratory tract infection in 2 months to 2-year-old children.

BACKGROUND AND OBJECTIVE: Acute lower respiratory tract infections (ALRI) are a common cause of paediatric emergency visits in young children. We studied risk factors for hospitalization and developed a clinical score for predicting hospitalization among 2 months to 2-year-old children with ALRI. METHODS: We conducted this prospective cohort study in the paediatric emergency department of a tertiary-care teaching hospital in India. Consecutive children, aged 2 months to 2 years with ALRI were enrolled from 15 December 2011 to 14 December 2012. A total of 26 a priori identified, putative risk factors were studied among enrolled children. We determined independent predictors of hospital admission (primary outcome) through multi-variable logistic regression analysis and assimilated them into a clinical risk score using regression coefficients. RESULTS: A total of 240 children (130 admissions) with ALRI were enrolled. Eleven clinical risk factors, which displayed association with hospital admission on univariate analysis (P < 0.1), were entered into multi-variable logistic regression analysis. Five factors retained independent association and were incorporated in a predictive score for hospitalization: tachypnoea (score of 5), chest retractions (score of 3), temperature > 37.8°C (score of 3), SpO2 < 92% at room air (score of 4), GCS < 15 (score of 6). Area under the receiver operator characteristic curve was 0.80 (95% CI: 0.75-0.85, P < 0.001). CONCLUSION: Five clinical risk factors-tachypnoea, chest retractions, fever > 37.8°C, SpO2 < 92% and GCS < 15-independently predicted hospital admission in infants with ALRI. A novel clinical score predicting hospital admission is presented.

Initiating nasal continuous positive airway pressure in preterm neonates at 5 cm as against 7 cm did not decrease the need for mechanical ventilation.

AIM: The optimum starting nasal continuous positive airway pressure (nCPAP) for infants on bubble nCPAP is unknown. We compared whether an initial bubble nCPAP of 7 cm rather than 5 cm of water prevented the need for mechanical ventilation among preterm neonates with respiratory distress. METHODS: Preterm neonates born at 27-34 weeks with the onset of respiratory distress within 24 hours of birth were randomised to receive high or standard nCPAP at either 7 cm or 5 cm of water, respectively. The primary outcome was the need for mechanical ventilation in the first week of life. RESULTS: The baseline characteristics were comparable between the two groups. The proportion of infants who required mechanical ventilation during the first week of life was similar between the two groups (standard 29/133, 21.8% versus high 30/138, 21.7%), with a relative risk of 0.99 and range of 0.56-1.77. The secondary outcomes were similar between the two groups, including mortality before discharge, pulmonary air leaks, need of surfactant therapy, bronchopulmonary dysplasia and duration of nCPAP. CONCLUSION: Initiating nCPAP at a higher pressure of 7 cm in preterm neonates with respiratory distress, rather than the standard 5 cm, did not decrease the need for mechanical ventilation during the first week of life.