Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight.

BACKGROUND: "Kangaroo mother care," a type of newborn care involving skin-to-skin contact with the mother or other caregiver, reduces mortality in infants with low birth weight (<2.0 kg) when initiated after stabilization, but the majority of deaths occur before stabilization. The safety and efficacy of kangaroo mother care initiated soon after birth among infants with low birth weight are uncertain. METHODS: We conducted a randomized, controlled trial in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania involving infants with a birth weight between 1.0 and 1.799 kg who were assigned to receive immediate kangaroo mother care (intervention) or conventional care in an incubator or a radiant warmer until their condition stabilized and kangaroo mother care thereafter (control). The primary outcomes were death in the neonatal period (the first 28 days of life) and in the first 72 hours of life. RESULTS: A total of 3211 infants and their mothers were randomly assigned to the intervention group (1609 infants with their mothers) or the control group (1602 infants with their mothers). The median daily duration of skin-to-skin contact in the neonatal intensive care unit was 16.9 hours (interquartile range, 13.0 to 19.7) in the intervention group and 1.5 hours (interquartile range, 0.3 to 3.3) in the control group. Neonatal death occurred in the first 28 days in 191 infants in the intervention group (12.0%) and in 249 infants in the control group (15.7%) (relative risk of death, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P = 0.001); neonatal death in the first 72 hours of life occurred in 74 infants in the intervention group (4.6%) and in 92 infants in the control group (5.8%) (relative risk of death, 0.77; 95% CI, 0.58 to 1.04; P = 0.09). The trial was stopped early on the recommendation of the data and safety monitoring board owing to the finding of reduced mortality among infants receiving immediate kangaroo mother care. CONCLUSIONS: Among infants with a birth weight between 1.0 and 1.799 kg, those who received immediate kangaroo mother care had lower mortality at 28 days than those who received conventional care with kangaroo mother care initiated after stabilization; the between-group difference favoring immediate kangaroo mother care at 72 hours was not significant. (Funded by the Bill and Melinda Gates Foundation; Australian New Zealand Clinical Trials Registry number, ACTRN12618001880235; Clinical Trials Registry-India number, CTRI/2018/08/015369.).

Newborns requiring resuscitation: Two thirds have heart rate ≥100 beats/minute in the first minute after birth.

AIM: The aim was to study the prevalence of bradycardia at birth in newborns requiring positive pressure ventilation (PPV), distribution of first measured heart rate (HR), changes in HR before start of PPV and HR response to PPV. METHODS: A population-based study including newborns ≥30 weeks' gestation receiving PPV at birth. HR was captured immediately after birth and continuously throughout resuscitation using the dry-electrode ECG device NeoBeat. Time of birth was registered in the Liveborn app. Provision of PPV was captured by video. RESULTS: We included 98 newborns receiving PPV at birth. Among newborns with HR measured within 60 s after birth, median (quartiles) first HR was 112 (84, 149) bpm recorded 19 (14, 37) s after birth, of which 33% had first HR <100 and 10% had first HR <60 bpm respectively. First HR was widely distributed. Median HR at start PPV 69 s after birth was 129 bpm. In newborns with an initial low HR, HR typically remained low for 20 s of PPV before increasing rapidly over the next 20-30 s. CONCLUSIONS: First measured HR was ≥100 bpm in two thirds of newborns receiving PPV. In bradycardic infants, HR did not increase until after 20 s of PPV.

Immediate skin-to-skin contact after birth ensures stable thermoregulation in very preterm infants in high-resource settings.

AIM: To investigate the impact of immediate skin-to-skin contact with a parent after birth on thermal regulation in very preterm infants. METHODS: This clinical trial was conducted in three neonatal intensive care units in Scandinavia from 2018 to 2021. Infants born between 28 + 0 and 32 + 6 weeks and days of gestation were randomised to immediate skin-to-skin contact or conventional care in an incubator during the first 6 postnatal hours. We report on a secondary outcome: serial measurements of axillary temperature. RESULTS: Ninety-one infants were randomised to skin-to-skin contact or conventional care. Mean (range) gestational ages were 31 + 2 (28 + 6, 32 + 5) and 31 + 0 (28 + 4, 32 + 6) weeks and days, mean birth weights were 1572 (702, 2352) and 1495 (555, 2440) grams, respectively. Mean (95%CI, p-value) temperatures were within the normal range in both groups, 0.2°C (-0.29, -0.14, p < 0.001) lower in the skin-to-skin contact group. The skin-to-skin contact group had a lower relative risk (95%CI, p-value) of developing events of hyperthermia, RR = 0.70 (0.50, 0.99, p = 0.04). CONCLUSIONS: Very preterm infants, irrespective of clinical stability, do not develop hypothermia during immediate skin-to-skin contact after birth. Immediate skin-to-skin contact did protect against events of hyperthermia. Concerns about thermal regulation should not limit implementation of immediate skin-to-skin contact in high-resource settings.

Immediate skin-to-skin contact may have beneficial effects on the cardiorespiratory stabilisation in very preterm infants.

AIM: Our aim was to investigate what effect immediate skin-to-skin contact with a parent had on the cardiorespiratory stabilisation of very preterm infants. METHODS: This randomised clinical trial was conducted during 2018-2021 at two university hospitals with three neonatal intensive care units in Norway and Sweden. Infants born from 28+0 to 32+6 weeks of gestation were randomised to immediate skin-to-skin contact with a parent for the first six postnatal hours or standard incubator care. The outcome was a composite cardiorespiratory stability score, based on serial measures of heart and respiratory rate, respiratory support, fraction of inspired oxygen and oxygen saturation. RESULTS: We recruited 91 newborn infants with a mean gestational age of 31+1 (range 28+4-32+6) weeks and mean birth weight of 1534 (range 555-2440) g: 46 received immediate skin-to-skin contact and 45 received incubator care. The group who received skin-to-skin contact had an adjusted mean score of 0.52 higher (95% confidence interval 0.38-0.67, p < 0.001) on a scale from zero to six when compared to the control group. CONCLUSION: Immediate skin-to-skin contact for the first six postnatal hours had beneficial effects on the cardiorespiratory stabilisation of very preterm infants.

Newborn resuscitation timelines: Accurately capturing treatment in the delivery room.

OBJECTIVES: To evaluate the use of newborn resuscitation timelines to assess the incidence, sequence, timing, duration of and response to resuscitative interventions. METHODS: A population-based observational study conducted June 2019-November 2021 at Stavanger University Hospital, Norway. Parents consented to participation antenatally. Newborns ≥28 weeks' gestation receiving positive pressure ventilation (PPV) at birth were enrolled. Time of birth was registered. Dry-electrode electrocardiogram was applied as soon as possible after birth and used to measure heart rate continuously during resuscitation. Newborn resuscitation timelines were generated from analysis of video recordings. RESULTS: Of 7466 newborns ≥28 weeks' gestation, 289 (3.9%) received PPV. Of these, 182 had the resuscitation captured on video, and were included. Two-thirds were apnoeic, and one-third were breathing ineffectively at the commencement of PPV. PPV was started at median (quartiles) 72 (44, 141) seconds after birth and continued for 135 (68, 236) seconds. The ventilation fraction, defined as the proportion of time from first to last inflation during which PPV was provided, was 85%. Interruption in ventilation was most frequently caused by mask repositioning and auscultation. Suctioning was performed in 35% of newborns, in 95% of cases after the initiation of PPV. PPV was commenced within 60 s of birth in 49% of apnoeic and 12% of ineffectively breathing newborns, respectively. CONCLUSIONS: Newborn resuscitation timelines can graphically present accurate, time-sensitive and complex data from resuscitations synchronised in time. Timelines can be used to enhance understanding of resuscitation events in data-guided quality improvement initiatives.

How Much Training Is Enough? Low-Dose, High-Frequency Simulation Training and Maintenance of Competence in Neonatal Resuscitation.

INTRODUCTION: Facemask ventilation is a crucial, but challenging, element of neonatal resuscitation.In a previously reported study, instructor-led training using a novel neonatal simulator resulted in high-level ventilation competence for health care providers (HCPs) involved in newborn resuscitation. The aim of this study was to identify the optimal frequency and dose of simulation training to maintain this competence level. METHODS: Prospective observational study of HCPs training through 9 months. All training was logged. Overall ventilation competence scores were calculated for each simulation case, incorporating 7 skill elements considered important for effective ventilation.Overall scores and skill elements were analyzed by generalized linear mixed effects models using frequency (number of months of 9 where training occurred and total number of training sessions in 9 months) and dose (total number of cases performed) as predictors. Training loads (frequency + dose) predictive of high scores were projected based on estimated marginal probabilities of successful outcomes. RESULTS: A total of 156 HCPs performed 4348 training cases. Performing 5 or more sessions in 9 months predicted high global competence scores (>28/30). Frequency was the best predictor for 4 skill elements; success in maintaining airway patency and ventilation fraction was predicted by performing training in, respectively, 2 and 3 months of 9, whereas for avoiding dangerously high inflating pressures and providing adequate mask seal, 5 and 6 sessions, respectively, over the 9 months, predicted success. Skills reflecting global performance (successful resuscitation and valid ventilations) and ventilation rate were more dose-dependent. CONCLUSIONS: Training frequency is important in maintaining neonatal ventilation competence. Training dose is important for some skill elements. This offers the potential for individualized training schedules.

Long-term faecal carriage in infants and intra-household transmission of CTX-M-15-producing Klebsiella pneumoniae following a nosocomial outbreak.

OBJECTIVES: To investigate the duration of faecal carriage of CTX-M-15-producing Klebsiella pneumoniae in infants colonized during a nosocomial neonatal intensive care unit (NICU) outbreak after discharge from hospital, possible risk factors for long-term colonization and transmission to household contacts (HCs). METHODS: Fifty-one infants colonized with two unrelated clones of CTX-M-15 K. pneumoniae [sequence type (ST) 17 and ST485] during an NICU outbreak and 60 HCs provided faecal and rectal samples, respectively, every 1-3 months after hospital discharge. Extended-spectrum ß-lactamase (ESBL)-producing strains of K. pneumoniae were identified on Chrom ID ESBL agar and examined by antimicrobial susceptibility testing. blaCTX-M-15 was detected by PCR and DNA sequencing. Clonal relationship was examined by PFGE. RESULTS: The median carriage time in infants after discharge was 12.5 months (IQR 9.5-17.5). Stable antimicrobial susceptibility patterns in PFGE-related strains confirmed the intestinal persistence of both outbreak strains. Risk factors for prolonged faecal carriage in infants were delivery by caesarean section [hazard ratio (HR) 2.4, 95% CI 1.1-5.5, P = 0.029] and treatment with antibiotics during hospitalization (HR 4.5, 95% CI 1.6-12.6, P = 0.004). Transmission of CTX-M-15 K. pneumoniae was observed in 9/28 (32%) households. Median carriage length in parents was 2.5 months (IQR 1.0-5.0) (P < 0.001 compared with infants). CONCLUSIONS: Infants may be long-term faecal carriers of ESBL-producing K. pneumoniae after colonization during hospitalization in the neonatal period. Delivery by caesarean section and antibiotic treatment during hospitalization are possible risk factors for prolonged carriage. Faecal ESBL carriage in infants represents a reservoir for intra-household spread of ESBL-producing K. pneumoniae.

Risk factors for acquisition of CTX-M-15 extended-spectrum beta-lactamase-producing Klebsiella pneumoniae during an outbreak in a neonatal intensive care unit in Norway.

BACKGROUND: A CTX-M-15 extended-spectrum beta-lactamase (ESBL)-producing Klebsiella pneumoniae was responsible for an outbreak in the neonatal intensive care unit (NICU) at Stavanger University Hospital, Norway over a 5-month period (November 2008-April 2009). The risk factors for acquiring ESBL-producing K. pneumoniae during the outbreak were examined in this study. METHODS: Faecal or rectal cultures were obtained from infants hospitalized in the NICU during the outbreak period and examined for ESBL-producing K. pneumoniae. Data were retrospectively retrieved from the medical records, including sex, gestational age, birth weight, indwelling central vascular catheter, continuous positive airway pressure (CPAP), mechanical ventilation, parenteral nutrition, antibiotic treatment, mode of delivery (vaginal vs caesarean), length of hospital stay, and mortality. RESULTS: A total of 216 infants were hospitalized in the NICU during the outbreak period, of whom 212 were screened; 51 (24%) scored positive for faecal colonization with ESBL-producing K. pneumoniae. One infant acquired a clinical infection. Forty-four colonized infants and 55 non-colonized infants were included in the risk analysis. Colonized infants had a lower birth weight, lower gestational age, and a longer hospital stay compared to non-colonized infants. By logistic regression, prematurity (gestational age <37 weeks) and treatment with antibiotics were independent risk factors for acquiring ESBL-producing K. pneumoniae in the final model. CONCLUSION: Prematurity and treatment with antibiotics were independent risk factors for colonization during this NICU outbreak with ESBL-producing K. pneumoniae.

Use of Pulse Oximetry during Resuscitation of 230 Newborns-A Video Analysis.

BACKGROUND: European guidelines recommend the use of pulse oximetry (PO) during newborn resuscitation, especially when there is a need for positive pressure ventilation or supplemental oxygen. The objective was to evaluate (i) to what extent PO was used, (ii) the time and resources spent on the application of PO, and (iii) the proportion of time with a useful PO signal during newborn resuscitation. METHODS: A prospective observational study was conducted at Stavanger University Hospital, Norway, between 6 June 2019 and 16 November 2021. Newborn resuscitations were video recorded, and the use of PO during the first ten minutes of resuscitation was recorded and analysed. RESULTS: Of 7466 enrolled newborns, 289 (3.9%) received ventilation at birth. The resuscitation was captured on video in 230 cases, and these newborns were included in the analysis. PO was applied in 222 of 230 (97%) newborns, median (quartiles) 60 (24, 58) seconds after placement on the resuscitation table. The proportion of time used on application and adjustments of PO during ongoing ventilation and during the first ten minutes on the resuscitation table was 30% and 17%, respectively. Median two healthcare providers were involved in the PO application. Video of the PO monitor signal was available in 118 (53%) of the 222 newborns. The proportion of time with a useful PO signal during ventilation and during the first ten minutes on the resuscitation table was 5% and 35%, respectively. CONCLUSION: In total, 97% of resuscitated newborns had PO applied, in line with resuscitation guidelines. However, the application of PO was time-consuming, and a PO signal was only obtained 5% of the time during positive pressure ventilation.

Prevalence of bradycardia in 4876 newborns in the first minute after birth and association with positive pressure ventilation: a population-based cross-sectional study.

OBJECTIVE: To determine the prevalence of bradycardia in the first minute after birth and association with positive pressure ventilation (PPV). METHOD: A population-based cross-sectional study was conducted from June 2019 to December 2021 at Stavanger University Hospital, Norway. Parents consented to participation during pregnancy, and newborns ≥28 weeks' gestation were included at birth. Heart rate (HR) was captured immediately after birth and continuously for the first minute(s). Time of birth was registered on a tablet. Provision of PPV was captured using video. RESULTS: Of 4876 included newborns, 164 (3.4%) did not breathe (two-thirds) or breathed ineffectively (one-third) and received PPV at birth. HR in the first minute had a wide distribution. The prevalence of first measured HR <100 and <60 beats/minute at median 16 s was 16.3% and 0.6%, respectively. HR increased in most cases. At 60 s, 3.7% had HR <100 beats/minute, of which 82% did not require PPV. In total, 25% of newborns had some registered HR <100 beats/minute during the first minute, of which 95% did not require PPV. Among newborns who received PPV, 76% and 62% had HR ≥100 beats/minute at 60 s and at start PPV, respectively. CONCLUSION: Bradycardia with HR <100 bpm in the first minute of life was frequent, but mostly self-resolved. Among the 4% of newborns that remained bradycardic at 60 s, only 20% received PPV. Two-thirds of resuscitated newborns had HR ≥100 beats/minute at start PPV. None of the ventilated newborns were breathing adequately at start PPV. TRIAL REGISTRATION NUMBER: NCT03849781.

Incomplete Exhalation during Resuscitation-Theoretical Review and Examples from Ventilation of Newborn Term Infants.

BACKGROUND: Newborn resuscitation guidelines recommend positive pressure ventilation (PPV) for newborns who do not establish effective spontaneous breathing after birth. T-piece resuscitator systems are commonly used in high-resource settings and can additionally provide positive end-expiratory pressure (PEEP). Short expiratory time, high resistance, rapid dynamic changes in lung compliance and large tidal volumes increase the possibility of incomplete exhalation. Previous publications indicate that this may occur during newborn resuscitation. Our aim was to study examples of incomplete exhalations in term newborn resuscitation and discuss these against the theoretical background. METHODS: Examples of flow and pressure data from respiratory function monitors (RFM) were selected from 129 term newborns who received PPV using a T-piece resuscitator. RFM data were not presented to the user during resuscitation. RESULTS: Examples of incomplete exhalation with higher-than-set PEEP-levels were present in the recordings with visual correlation to factors affecting time needed to complete exhalation. CONCLUSIONS: Incomplete exhalation and the relationship to expiratory time constants have been well described theoretically. We documented examples of incomplete exhalations with increased PEEP-levels during resuscitation of term newborns. We conclude that RFM data from resuscitations can be reviewed for this purpose and that incomplete exhalations should be further explored, as the clinical benefit or risk of harm are not known.

Within-patient and global evolutionary dynamics of Klebsiella pneumoniae ST17.

Klebsiella pneumoniae sequence type (ST) 17 is a global problem clone that causes multidrug-resistant (MDR) hospital infections worldwide. In 2008-2009, an outbreak of MDR ST17 occurred at a neonatal intensive care unit (NICU) in Stavanger, Norway. Fifty-seven children were colonized. We observed intestinal persistence of ST17 in all of the children for up to two years after hospital discharge. Here, we investigated the within-host evolution of ST17 in 45 of those children during long-term colonization and compared the outbreak with 254 global strains. Ninety-two outbreak-related isolates were whole-genome sequenced. They had capsule locus KL25, O locus O5 and carried yersiniabactin. During within-host colonization ST17 remained stable with few single nucleotide polymorphisms, no acquisition of antimicrobial resistance (AMR) or virulence determinants, and persistent carriage of a bla CTX-M-15-encoding IncFII(K) IncFIB(K) plasmid (pKp2177_1). The global collection included ST17 from 1993 to 2020 from 34 countries, that were from human infection (41.3%), colonization (39.3%) and respiratory specimens (7.3%), from animals (9.3%), and from the environment (2.7%). We estimate that ST17 emerged mid-to-late 19th century (1859, 95 % HPD 1763-1939) and diversified through recombinations of the K and O loci to form several sublineages, with various AMR genes, virulence loci and plasmids. There was limited evidence of persistence of AMR genes in any of these lineages. A globally disseminated sublineage with KL25/O5 accounted for 52.7 % of the genomes. It included a monophyletic subclade that emerged in the mid-1980s, which comprised the Stavanger NICU outbreak and 10 genomes from three other countries, which all carried pKp2177_1. The plasmid was also observed in a KL155/OL101 subclade from the 2000s. Three clonal expansions of ST17 were identified; all were healthcare-associated and carried either yersiniabactin and/or pKp2177_1. To conclude, ST17 is globally disseminated and associated with opportunistic hospital-acquired infections. It contributes to the burden of global MDR infections, but many diverse lineages persist without acquired AMR. We hypothesize that non-human sources and human colonization may play a crucial role for severe infections in vulnerable patients, such as preterm neonates.

Skin-to-Skin Contact at Birth for Very Preterm Infants and Mother-Infant Interaction Quality at 4 Months: A Secondary Analysis of the IPISTOSS Randomized Clinical Trial.

Importance: Good-quality parent-infant interactions have protective effects on infant socio-emotional and behavioral development. These interactions are especially critical for very preterm infants at risk of vulnerabilities related to immaturity. Skin-to-skin contact (SSC) has been found to improve mother-preterm infant interaction behaviors, but few studies exist regarding its benefits when initiated immediately after birth. Objective: To determine the effect of immediate SSC at birth for very preterm infants on mother-infant interaction quality at 4 months of corrected age. Design, Setting, and Participants: This secondary analysis used data from the Immediate Parent-Infant Skin-to-Skin Study (IPISTOSS), a randomized clinical trial conducted between April 1, 2018, and June 30, 2021, at 3 neonatal units in Sweden and Norway. Participants included very preterm infants (28-33 gestational weeks of age) and their parents. Four-month follow-up was concluded in December 2021. Data analyses were performed on March 16 and September 18, 2023. Intervention: Infants were allocated to standard incubator care or SSC with either parent initiated at birth and continued throughout the first 6 hours after birth. Main Outcomes and Measures: The primary outcome was mother-infant interaction quality as measured with the Parent-Child Early Relational Assessment (PCERA), based on video recordings of a 5-minute free-play situation with mother-infant dyads at 4 months of corrected age. A multilevel regression analysis was performed. Results: This analysis included 71 infants (31 twins [44%]) and 56 mothers. Infants had a mean (SD) gestational age of 31 weeks 3 (1.3) days, and more than half were male (42 [59%]); mothers had a mean (SD) age of 32 (4.9) years. There were 37 infants allocated to standard care and 34 to SSC with either parent after birth. During the first 6 hours after birth, fathers provided more SSC than mothers, with a median (IQR) of 3.25 (2.25-4.5) and 0.75 (0-2.5) hours, respectively. A statistically significant difference in 1 of 5 PCERA subscales (subscale 3: infant positive affect, communicative and social skills) was observed, with higher-quality mother-infant interaction in the SSC group at 4 months (Cohen d = 0.67 [95% CI, 0.17 to 1.17]; P = .01). This effect remained significant when adjusting for primiparity, child sex, and observation setting. Conclusions and Relevance: In this study of the effect of immediate parent-infant SSC after very preterm birth, SSC was beneficial for the mother-infant relationship. These findings suggest that immediate SSC should be supported in the clinical setting. Trial Registration: ClinicalTrials.gov Identifier: NCT03521310.

Immediate skin-to-skin contact for low birth weight infants is safe in terms of cardiorespiratory stability in limited-resource settings.

Aim: To investigate the safety of skin-to-skin contact initiated immediately after birth on cardiorespiratory parameters in unstable low birth weight infants. Methods: A randomized clinical trial was conducted in tertiary newborn units in Ghana, India, Malawi, Nigeria and Tanzania in 2017-2020, in infants with birth weight 1.0-1.799 kg. The intervention was Kangaroo mother care initiated immediately after birth and continued until discharge compared to conventional care with Kangaroo mother care initiated after meeting stability criteria. The results of the primary study showed that immediate Kangaroo mother care reduced neonatal mortality by 25% and the results have been published previously. The post-hoc outcomes of this study were mean heart rate, respiratory rate, oxygen saturation during the first four days and the need of respiratory support. Results: 1,602 infants were allocated to control and 1,609 to intervention. Mean birth weight was 1.5 kg (SD 0.2) and mean gestational age was 32.6 weeks (SD 2.9). Infants in the control group had a mean heart rate 1.4 beats per minute higher (95% CI -0.3-3.1, p = 0.097), a mean respiratory rate 0.4 breaths per minute higher (-0.7-1.5, p = 0.48) and a mean oxygen saturation 0.3% higher (95% CI -0.1-0.7, p = 0.14) than infants in the intervention group. Conclusion: There were no significant differences in cardiorespiratory parameters during the first four postnatal days. Skin-to-skin contact starting immediately after birth is safe in low birth weight infants in limited-resource settings.

Associations between unit workloads and outcomes of first extubation attempts in extremely premature infants below a gestational age of 26 weeks.

Objective: The objective was to explore whether high workloads in neonatal intensive care units were associated with short-term respiratory outcomes of extremely premature (EP) infants born <26 weeks of gestational age. Methods: This was a population-based study using data from the Norwegian Neonatal Network supplemented by data extracted from the medical records of EP infants <26 weeks GA born from 2013 to 2018. To describe the unit workloads, measurements of daily patient volume and unit acuity at each NICU were used. The effect of weekend and summer holiday was also explored. Results: We analyzed 316 first planned extubation attempts. There were no associations between unit workloads and the duration of mechanical ventilation until each infant's first extubation or the outcomes of these attempts. Additionally, there were no weekend or summer holiday effects on the outcomes explored. Workloads did not affect the causes of reintubation for infants who failed their first extubation attempt. Conclusion: Our finding that there was no association between the organizational factors explored and short-term respiratory outcomes can be interpreted as indicating resilience in Norwegian neonatal intensive care units.

Effect on neonatal sepsis following immediate kangaroo mother care in a newborn intensive care unit: a post-hoc analysis of a multicentre, open-label, randomised controlled trial.

Background: To implement the immediate Kangaroo mother care (iKMC) intervention in the previous multicentre, open-label, randomised controlled trial, the mother or a surrogate caregiver and neonate needed to be together continuously, which led to the concept of the Mother-Newborn Care Unit (MNCU). Health-care providers and administrators were concerned of the potential increase in infections caused by the continuous presence of mothers or surrogates in the MNCU. We aimed to assess the incidence of neonatal sepsis in sub-groups and the bacterial profile among intervention and control neonates in the study population. Methods: This is a post-hoc analysis of the previous iKMC trial, which was conducted in five level 2 Newborn Intensive Care Units (NICUs) one each in Ghana, India, Malawi, Nigeria, and Tanzania, in neonates with birth weight 1 to <1.8 kg. The intervention was KMC initiated immediately after birth and continued until discharge and compared to conventional care with KMC initiated after meeting stability criteria. The primary outcomes of this report were the incidence of neonatal sepsis in sub-groups, sepsis-related mortality and bacterial profile of isolates during hospital stay. The original trial is registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12618001880235) and the Clinical Trials Registry-India (CTRI/2018/08/01536). Findings: Between November 30, 2017, and January 20, 2020, 1609 newborns in the intervention group and in the control group 1602 newborns were enrolled in iKMC study. 1575 newborns in the intervention group and 1561 in the control group were clinically evaluated for sepsis. Suspected sepsis was 14% lower in intervention group in sub-group of neonates with birth weight 1.0-<1.5 kg; RR 0.86 (CI 0.75, 0.99). Among neonates with birth weight 1.5-<1.8 kg, suspected sepsis was reduced by 24%; RR 0.76 (CI 0.62, 0.93). Suspected sepsis rates were lower in intervention group than in the control group across all sites. Sepsis related mortality was 37% less in intervention group than the control group; RR 0.63 (CI 0.47-0.85) which was statistically significant. The intervention group had fewer cases of Gram-negative isolates (n = 9) than Gram positive isolates (n = 16). The control group had more cases of Gram-negative isolates (n = 18) than Gram positive (n = 12). Interpretation: Immediate Kangaroo Mother care is an effective intervention to prevent neonatal sepsis and sepsis related mortality. Funding: The original trial was funded by the Bill and Melinda Gates Foundation through a grant to the World Health Organization (grant No. OPP1151718).

Tidal volumes and pressures delivered by the NeoPuff T-piece resuscitator during resuscitation of term newborns.

AIM: T-piece resuscitators are commonly used for respiratory support during newborn resuscitation. This study aimed to describe delivered pressures and tidal volumes when resuscitating term newborns immediately after birth, using the NeoPuff T-piece resuscitator. METHOD: Observational study from June 2019 through March 2021 at Stavanger University Hospital, Norway, including term newborns ventilated with a T-piece resuscitator after birth, with consent to participate. Ventilation parameters of the first 100 inflations from each newborn were recorded by respiration monitors and divided into an early (inflation 1-20) and a late (inflation 21-100) phase. RESULTS: Of the 7730 newborns born, 232 term newborns received positive pressure ventilation. Of these, 129 newborns were included. In the early and the late phase, the median (interquartile range) peak inflating pressure was 30 (28-31) and 30 (27-31) mbar, and tidal volume was 4.5 (1.6-7.8) and 5.7 (2.2-9.8) ml/kg, respectively. Increased inflation times were associated with an increase in volume before plateauing at an inflation time of 0.41 s in the early phase and 0.50 s in the late phase. Inflation rates exceeding 32 per minute in the early phase and 41 per minute in the late phase were associated with lower tidal volumes. CONCLUSION: There was a substantial variation in tidal volumes despite a relatively stable peak inflating pressure. Delivered tidal volumes were at the lower end of the recommended range. Our results indicate that an inflation time of approximately 0.5 s and rates around 30-40 per minute are associated with the highest delivered tidal volumes.

Impact of immediate and continuous heart rate feedback by dry electrode ECG on time to initiation of ventilation after birth: protocol for a randomised controlled trial.

INTRODUCTION: 3%-8% of newborns need positive pressure ventilation (PPV) after birth. Heart rate (HR) is considered the most sensitive indicator of the newborns' condition and response to resuscitative interventions. According to guidelines, HR should be assessed and PPV initiated within 60 s after birth in non-breathing newborns. Dry electrode ECG can provide accurate feedback on HR immediately after birth and continuously during resuscitation. The impact of early and continuous HR feedback is unknown. METHOD AND ANALYSIS: This single-centre randomised controlled trial seeks to determine if HR feedback by dry electrode ECG immediately after birth and continuously during newborn resuscitation results in more timely initiation of PPV, improved ventilation and short-term outcomes compared with standard HR assessment.In all newborns≥34 gestational weeks, the dry electrode ECG sensor is placed on the upper abdomen immediately after birth as an additional modality of HR assessment. The device records and stores HR signals. In intervention subjects, the HR display is visible to guide decision-making and further management, in control subjects the display is masked. Standard HR assessment is by stethoscope, gel-electrode ECG and/or pulse oximetry (PO).Time of birth is registered in the Liveborn app. Time of initiation and duration of PPV is calculated from video recordings. Ventilation parameters are retrieved from the ventilation monitor, oxygen saturation and HR from the PO and gel-electrode ECG monitors.The primary endpoint is proportion of resuscitated newborns who receive PPV within 60 s after birth. To detect a 50% increase with power of 90% using an overall significance level of 0.05 and 1 interim analysis, 169 newborns are needed in each group. ETHICS AND DISSEMINATION: Approval by the Norwegian National Research Ethics Committee West (2018/338). Parental consent is sought at routine screening early in pregnancy. The results will be published in peer-reviewed journal and presented at conferences. TRIAL REGISTRATION NUMBER: NCT03849781.

Predictors of extubation success: a population-based study of neonates below a gestational age of 26 weeks.

OBJECTIVE: The aim of the study was to investigate first extubation attempts among extremely premature (EP) infants and to explore factors that may increase the quality of clinical judgement of extubation readiness. DESIGN AND METHOD: A population-based study was conducted to explore first extubation attempts for EP infants born before a gestational age (GA) of 26 weeks in Norway between 1 January 2013 and 31 December 2018. Eligible infants were identified via the Norwegian Neonatal Network database. The primary outcome was successful extubation, defined as no reintubation within 72 hours after extubation. RESULTS: Among 482 eligible infants, 316 first extubation attempts were identified. Overall, 173 (55%) infants were successfully extubated, whereas the first attempt failed in 143 (45%) infants. A total of 261 (83%) infants were extubated from conventional ventilation (CV), and 55 (17%) infants were extubated from high-frequency oscillatory ventilation (HFOV). In extubation from CV, pre-extubation fraction of inspired oxygen (FiO2) ≤0.35, higher Apgar score, higher GA, female sex and higher postnatal age were important predictors of successful extubation. In extubation from HFOV, a pre-extubation FiO2 level ≤0.35 was a relevant predictor of successful extubation. CONCLUSIONS: The correct timing of extubation in EP infants is important. In this national cohort, 55% of the first extubation attempts were successful. Our results suggest that additional emphasis on oxygen requirement, sex and general condition at birth may further increase extubation success when clinicians are about to extubate EP infants for the first time.