Importance:Clesrovimab is a long-acting monoclonal antibody approved for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season; data concerning clesrovimab from a second RSV season among children who remain at risk for severe disease are needed. Objective:To evaluate the safety and tolerability of clesrovimab (105 mg) vs palivizumab in RSV season 1 in infants at increased risk for severe RSV disease. Key secondary objectives include describing the safety of 210 mg of clesrovimab in RSV season 2 in children who remain at increased risk for severe RSV disease, clesrovimab pharmacokinetics, and the incidence of RSV-associated disease. Design, Setting, and Participants:SMART (MK-1654-007) was a randomized, partially masked, palivizumab-controlled, phase 3 clinical trial, conducted at 110 sites in 27 countries and territories between November 30, 2021, and November 20, 2025. The population constituted palivizumab-eligible infants, including those with prematurity, chronic lung disease of prematurity, or hemodynamically significant congenital heart disease. Interventions:Participants, randomized 1:1 and stratified by region and condition, received clesrovimab (105 mg) on day 1 followed by placebo on day 28 or monthly palivizumab (15 mg/kg) up to 5 doses (1 dose per month). Eligible infants received open-label clesrovimab (210 mg) before their second RSV season. Main Outcomes and Measures:The primary outcome was the observed proportions of participants experiencing adverse events (AEs) after clesrovimab or palivizumab in season 1. Results:Overall, 997 infants (500 [50.2%] male; median age, 2.6 [range, 0.0-12.0] months) received clesrovimab, 105 mg (n = 498) or palivizumab (n = 499) in season 1; 276 received clesrovimab, 210 mg open-label in season 2. In season 1, the proportions of participants experiencing AEs were comparable between treatment groups. In season 2, clesrovimab, 210 mg was well tolerated. Incidence rates of RSV-associated medically attended lower respiratory infection (MALRI) were comparable between clesrovimab and palivizumab (3.2% [95% CI, 1.8%-5.2%] and 3.4% [95% CI, 2.0%-5.6%], respectively) through day 150 in season 1; total RSV-associated MALRI incidence through day 180 after a 210-mg dose in season 2 was 7.3% (95% CI, 4.4%-11.4%). Conclusions and Relevance:In this randomized clinical trial, clesrovimab was well tolerated in infants at increased risk for severe RSV disease through 2 RSV seasons. These findings support the use of clesrovimab in children who remain at risk for severe RSV disease in their second RSV season. Trial Registration:ClinicalTrials.gov Identifier: NCT04938830.

Importance Clesrovimab is a long-acting monoclonal antibody approved for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season; data concerning clesrovimab from a second RSV season among children who remain at risk for severe disease are needed. Objective To evaluate the safety and tolerability of clesrovimab (105 mg) vs palivizumab in RSV season 1 in infants at increased risk for severe RSV disease. Key secondary objectives include describing the safety of 210 mg of clesrovimab in RSV season 2 in children who remain at increased risk for severe RSV disease, clesrovimab pharmacokinetics, and the incidence of RSV-associated disease. Design, Setting, and Participants SMART (MK-1654-007) was a randomized, partially masked, palivizumab-controlled, phase 3 clinical trial, conducted at 110 sites in 27 countries and territories between November 30, 2021, and November 20, 2025. The population constituted palivizumab-eligible infants, including those with prematurity, chronic lung disease of prematurity, or hemodynamically significant congenital heart disease. Interventions Participants, randomized 1:1 and stratified by region and condition, received clesrovimab (105 mg) on day 1 followed by placebo on day 28 or monthly palivizumab (15 mg/kg) up to 5 doses (1 dose per month). Eligible infants received open-label clesrovimab (210 mg) before their second RSV season. Main Outcomes and Measures The primary outcome was the observed proportions of participants experiencing adverse events (AEs) after clesrovimab or palivizumab in season 1. Results Overall, 997 infants (500 [50.2%] male; median age, 2.6 [range, 0.0-12.0] months) received clesrovimab, 105 mg (n = 498) or palivizumab (n = 499) in season 1; 276 received clesrovimab, 210 mg open-label in season 2. In season 1, the proportions of participants experiencing AEs were comparable between treatment groups. In season 2, clesrovimab, 210 mg was well tolerated. Incidence rates of RSV-associated medically attended lower respiratory infection (MALRI) were comparable between clesrovimab and palivizumab (3.2% [95% CI, 1.8%-5.2%] and 3.4% [95% CI, 2.0%-5.6%], respectively) through day 150 in season 1; total RSV-associated MALRI incidence through day 180 after a 210-mg dose in season 2 was 7.3% (95% CI, 4.4%-11.4%). Conclusions and Relevance In this randomized clinical trial, clesrovimab was well tolerated in infants at increased risk for severe RSV disease through 2 RSV seasons. These findings support the use of clesrovimab in children who remain at risk for severe RSV disease in their second RSV season. Trial Registration ClinicalTrials.gov Identifier: NCT04938830

Deferred cord clamping (DCC) has been associated with reduced mortality in preterm infants, and a period of at least 30 s has been recommended before clamping. However, preterm infants assessed as being in need of resuscitation have often had earlier cord clamping. In this study, we aimed to compare neonatal outcomes for preterm infants undergoing DCC who established early breathing movements compared to those who were not breathing. After a 5 yr recruitment period, we recently completed the ABC study, in which preterm infants <31 weeks undergoing 50 s of DCC who were not breathing by 15 s of age were randomised into two groups: one received intermittent positive pressure ventilation (IPPV) and the other was a standard group, which received no breathing support. The outcomes in the two groups were similar, and for the present analysis, the groups were combined. Infants in the ABC study were compared with the cohort excluded from the original ABC study because they were breathing by 15 s (called the Breathing Before Clamping or BBC group). There were significant differences in demographics between the ABC and BBC groups. Spontaneous preterm labour was more common in the BBC group, and these infants were more likely to be delivered vaginally. Gestational age and birth weight were significantly higher in the BBC group (p < 0.01). Soon after birth, Apgar scores were significantly higher in the BBC group, with a lower base deficit on first obtained blood gas, and a smaller proportion were intubated in the delivery room. Fewer BBC infants were hypothermic (<36.5 °C) on admission. Multivariate regression analysis indicated whether infants were breathing or not at 15 s of age was linked predominantly to gestation. Important neonatal outcomes and a composite of these outcomes (mortality, severe intraventricular haemorrhage, bronchopulmonary dysplasia) were not significantly different between the ABC and BBC groups (odds ratio for the composite outcome was 1.77 CI 0.84–3.76 corrected for gestation). For very preterm infants undergoing DCC, important neonatal outcomes were related to gestational age and not independently associated with early breathing. There was a small group (7% of total) who were deemed compromised at birth and did not undergo DCC. These infants had significantly worse neonatal outcomes.

Background Most moderate-to-late-preterm infants need nutritional support until they are feeding exclusively on their mother's breast milk. Evidence to guide nutrition strategies for these infants is lacking.Methods We conducted a multicenter, factorial, randomized trial involving infants born at 32 weeks 0 days' to 35 weeks 6 days' gestation who had intravenous access and whose mothers intended to breast-feed. Each infant was assigned to three interventions or their comparators: intravenous amino acid solution (parenteral nutrition) or dextrose solution until full feeding with milk was established; milk supplement given when maternal milk was insufficient or mother's breast milk exclusively with no supplementation; and taste and smell exposure before gastric-tube feeding or no taste and smell exposure. The primary outcome for the parenteral nutrition and the milk supplement interventions was the body-fat percentage at 4 months of corrected gestational age, and the primary outcome for the taste and smell intervention was the time to full enteral feeding (150 ml per kilogram of body weight per day or exclusive breast-feeding).Results A total of 532 infants (291 boys [55%]) were included in the trial. The mean (+/- SD) body-fat percentage at 4 months was similar among the infants who received parenteral nutrition and those who received dextrose solution (26.0 +/- 5.4% vs. 26.2 +/- 5.2%; adjusted mean difference, -0.20; 95% confidence interval [CI], -1.32 to 0.92; P=0.72) and among the infants who received milk supplement and those who received mother's breast milk exclusively (26.3 +/- 5.3% vs. 25.8 +/- 5.4%; adjusted mean difference, 0.65; 95% CI, -0.45 to 1.74; P=0.25). The time to full enteral feeding was similar among the infants who were exposed to taste and smell and those who were not (5.8 +/- 1.5 vs. 5.7 +/- 1.9 days; P=0.59). Secondary outcomes were similar across interventions. Serious adverse events occurred in one infant.Conclusions This trial of routine nutrition interventions to support moderate-to-late-preterm infants until full nutrition with mother's breast milk was possible did not show any effects on the time to full enteral feeding or on body composition at 4 months of corrected gestational age. (Funded by the Health Research Council of New Zealand and others; DIAMOND Australian New Zealand Clinical Trials Registry number, ACTRN12616001199404.) In moderate-to-late-preterm infants, provision of parenteral nutrition, milk supplement, and exposure to taste and smell did not affect body composition at 4 months or time to full enteral feeding.

AIMS:High-sensitive troponin T (hs-TnT), N-terminal pro-B-type natriuretic peptide (NT-proBNP), and C-reactive protein (CRP) are established prognostic biomarkers for cardiovascular (CV) morbidity and mortality and frequently used in symptomatic and/or hospitalized adults with congenital heart disease (ACHD). Their prognostic value in clinically stable ACHD has not yet been well established. This study investigates the predictive value of hs-TnT, NT-proBNP, and CRP for survival and CV events in stable ACHD. METHODS AND RESULTS:In this prospective cohort study, 495 outpatient ACHD (43.9 ± 10.0 years, 49.1% female) underwent venous blood sampling including hs-TnT, NT-proBNP, and CRP. Patients were followed up for survival status and the occurrence of CV events. Survival analyses were performed with Cox proportional hazards regression analysis and Kaplan-Meier curves. During a mean follow-up of 2.8 ± 1.0 years, 53 patients (10.7%) died or reached a cardiac-related endpoint including sustained ventricular tachycardia, hospitalization with cardiac decompensation, ablation, interventional catheterization, pacer implantation, or cardiac surgery. Multivariable Cox regression revealed hs-TnT (P = 0.005) and NT-proBNP (P = 0.018) as independent predictors of death or cardiac-related events in stable ACHD, whilst the prognostic value of CRP vanished after multivariable adjustment (P = 0.057). Receiver-operator characteristic curve analysis identified cut-off values for event-free survival of hs-TnT ≤9 ng/L and NT-proBNP ≤200 ng/L. Patients with both increased biomarkers had a 7.7-fold (confidence interval 3.57-16.40, P < 0.001) higher risk for death and cardiac-related events compared with patients without elevated blood values. CONCLUSION:Subclinical values of hs-TnT and NT-proBNP are a useful, simple, and independent prognostic tool for adverse cardiac events and survival in stable outpatient ACHD. REGISTRATION:German Clinical Trial Registry DRKS00015248.

Objective: Gestational diabetes mellitus (GDM) is associated with offspring metabolic disease, including childhood obesity, but causal mediators remain to be established. We assessed the impact of lower versus higher thresholds for detection and treatment of GDM on infant risk factors for obesity, including body composition, growth, nutrition and appetite. Research design and methods: Prospective cohort study within the GEMS Trial; pregnant women were randomly allocated to detection of GDM using the lower criteria of the International Association of Diabetes and Pregnancy Study Groups or higher New Zealand criteria (ACTRN12615000290594). Randomly selected Control infants of women without GDM were compared with infants exposed to: A) GDM by lower but not higher criteria, with usual treatment for diabetes in pregnancy; B) GDM by lower but not higher criteria, untreated; C) GDM by higher criteria, treated. The primary outcome was whole-body fat mass at 5-6 months. Results: 760 infants enrolled; 432 assessed for the primary outcome. Fat mass was not significantly different between Controls (2.05kg) and exposure groups: A) GDM by lower but not higher criteria, treated (1.96kg), aMD -0.09 95%CI -0.29,0.10; B) GDM by lower but not higher criteria, untreated (1.94kg), aMD -0.15 95%CI -0.35,0.06; C) GDM detected and treated using higher thresholds (1.87kg), aMD -0.17 95%CI -0.37,0.03. Conclusion: GDM detected using lower but not higher criteria, was not associated with increased infant fat mass at 5-6 months, regardless of maternal treatment. GDM detected and treated using higher thresholds was also not associated with increased fat mass at 5-6 months.

Introduction Infants with severe or recurrent transitional hypoglycaemia continue to have high rates of adverse neurological outcomes and new treatment approaches are needed that target the underlying pathophysiology. Diazoxide is one such treatment that acts on the pancreatic β-cell in a dose-dependent manner to decrease insulin secretion.Methods and analysis Phase IIB, double-blind, two-arm, parallel, randomised trial of diazoxide versus placebo in neonates ≥35 weeks’ gestation for treatment of severe (blood glucose concentration (BGC)<1.2 mmol/L or BGC 1.2 to <2.0 mmol/L despite two doses of buccal dextrose gel and feeding in a single episode) or recurrent (≥3 episodes <2.6 mmol/L in 48 hours) transitional hypoglycaemia. Infants are loaded with diazoxide 5 mg/kg orally and then commenced on a maintenance dose of 1.5 mg/kg every 12 hours, or an equal volume of placebo. The intervention is titrated from the third maintenance dose by protocol to target BGC in the range of 2.6–5.4 mmol/L. The primary outcome is time to resolution of hypoglycaemia, defined as the first point at which the following criteria are met concurrently for ≥24 hours: no intravenous fluids, enteral bolus feeding and normoglycaemia. Groups will be compared for the primary outcome using Cox’s proportional hazard regression analysis, expressed as adjusted HR with a 95% CI.Ethics and dissemination This trial has been approved by the Health and Disability Ethics Committees of New Zealand (19CEN189). Findings will be disseminated in peer-reviewed journals, to clinicians and researchers at local and international conferences and to the public.Trial registration number ACTRN12620000129987.

AIMS High-sensitive-troponin-T (hs-TnT), N-terminal pro B-type natriuretic peptide (NT-proBNP), and C-reactive protein (CRP) are established prognostic biomarkers for cardiovascular morbidity and mortality and frequently used in symptomatic and/or hospitalized adults with congenital heart disease (ACHD). Their prognostic value in clinically stable ACHD is not yet well established. This study investigates the predictive value of hs-TnT, NT-proBNP and CRP for survival and cardiovascular events in stable ACHD. METHODS AND RESULTS In this prospective cohort study, 495 outpatient ACHD (43.9 ± 10.0 years, 49.1% female) underwent venous blood sampling including hs-TnT, NT-proBNP and CRP. Patients were followed-up for survival status and the occurrence of cardiovascular events. Survival analyses was performed with Cox proportional hazards regression analysis and Kaplan-Meier curves. During a mean follow-up of 2.8 ± 1.0 years, 53 patients (10.7%) died or reached a cardiac-related endpoint including sustained ventricular tachycardia, hospitalization with cardiac decompensation, ablation, interventional catheterization, pacer implantation or cardiac surgery. Multivariable Cox regression revealed hs-TnT (p = .005) and NT-proBNP (p = .018) as independent predictors of death or cardiac-related events in stable ACHD, whilst the prognostic value of CRP vanished after multivariable adjustment (p = .057). ROC curve analysis identified cut-off values for event-free survival of hs-TnT ≤9 ng/l and NT-proBNP ≤200 ng/l. Patients with both increased biomarkers had a 7.7-fold (CI 3.57-16.40, p < 0.001) higher risk for death and cardiac-related events compared to patients without elevated blood values. CONCLUSION Subclinical values of hs-TnT and NT-proBNP are a useful, simple, and independent prognostic tool for adverse cardiac events and survival in stable outpatient ACHD.

Background: Handgrip strength (HGS) indicates current and future health. Although preterm infants have an increased risk of poor grip strength in later life, its determinants and relationship with neurodevelopment are not well understood.Aims: To determine HGS in children born preterm and explore the relationship of HGS with demography, anthropometry, nutritional factors, and neurodevelopmental outcomes.Study design: A prospective cohort study of moderate-late preterm babies enrolled in a randomised trial of nutritional support strategies, the DIAMOND trial.Subjects: A total of 116 children born between 32 and 35 weeks' gestation, whose HGS was measured at 2 years' corrected age.Outcome measures: HGS was measured using a dynamometer, and neurodevelopment was assessed using the Bayley Scales of Infant Development-III. Anthropometry and body composition were assessed at birth, discharge, and at 4 months' and 2 years' corrected age. Information on demographics and breastfeeding practices, including type of milk at discharge and duration of exclusive breastfeeding, was collected using questionnaires.Results: The mean (standard deviation) HGS was 2.26 (1.07) kg. The Bayley scores were < 85 (-1 standard deviation) in 6 %, 20 %, and 1 % for the cognitive, language, and motor scales, respectively. Multiple regression analysis revealed that HGS was positively associated with language and motor scores (p < .05) after adjusting for confounding factors. HGS was not associated with sex, anthropometry, body composition, or breastfeeding practices. Maternal education was independently associated with HGS (p < .01).Conclusions: HGS at age 2 years in children born moderate-late preterm is associated with language and motor development and maternal education level.

Objective: The aim of this study was to determine how the coronavirus disease 2019 (COVID-19) pandemic affects the health-related quality of life (HRQoL) of children and adolescents with congenital heart disease (CHD), as well as how the parents perceive the HRQoL of their children. Patients and Methods: HRQoL was assessed by the KINDL® questionnaire during the COVID-19 pandemic and compared to recent questionnaire data of children of the Functional Outcome in children and adolescents with congenital heart disease (FOOTLOOSE) study. From May 27 to June 29, 2020, 160 children with various CHD (15.2 ± 2.5 years, 62 girls, age range: 10–18 years) completed this re-assessment of HRQoL. Results: HRQoL in children with CHD was significantly lower during the COVID-19 pandemic compared to before in total KINDL® score (by −2.1 ± 12.3, P = 0.030), and the subscales emotional well-being (by −5.4 ± 1.2, P < 0.001) and friends (by −4.5 ± 1.7, P = 0.009). Parents of children with CHD rate the HRQoL in total KINDL® score (mean difference: 3.9 ± 1.2, P = 0.002), and the subscales family (mean difference: 8.8 ± 1.7 standard estimate error [SEE], P < 0.001) and friends (mean difference: 7.6 ± 2.2 SEE, P < 0.001) even worse than their children. Only moderate degree of agreement was found between most of the sub-categorical HRQoL assessment of children with CHD and their parents. Conclusions: The COVID-19 pandemic had a negative impact on HRQoL in children and adolescents with CHD and their families. The psychological concerns of children with CHD and their families need special consideration by health-care providers during the COVID-19 pandemic.

Objective To determine if providing respiratory support to very preterm infants who fail to breathe regularly during deferred cord clamping (DCC) decreased red cell transfusion. Study design Infants less than 31 weeks of gestation undergoing DCC who were apneic or not breathing regularly at 15 seconds underwent stratified randomization. Pale, limp, and nonresponsive infants were excluded. The standard group received gentle stimulation in a neutral position for 50 seconds; the intervention group received intermittent positive pressure ventilation via face mask and T piece from 20 to 50 seconds of age with a fractional inspired oxygen of 0.3. The primary outcome was the proportion transfused, with a secondary composite outcome of death, severe intraventricular hemorrhage, or chronic lung disease. Results Of 311 assessed infants, 113 met the inclusion criteria and were studied; 57 received the intervention and 56 standard treatment. Patient characteristics were similar. Overall, 105 infants (93%) received the intended 50 seconds DCC (54 in the intervention group and 51 in the standard group). Rates of transfusion were similar (28% vs 30% in the intervention vs control groups), as were rates of the composite outcome (46% vs 38% in the intervention vs the control arms; P = .45). Conclusions Providing breathing support during 50 seconds of DCC in this single-center cohort seemed to be safe and feasible, but did not decrease the transfusion rates or improve outcomes.

OBJECTIVE:To determine whether weaning from nasal continuous positive airway pressure (nCPAP) using heated humidified high flow nasal cannula (nHF) was non-inferior to weaning using nCPAP alone in relation to time on respiratory support.STUDY DESIGN:Single-centre, non-inferiority, randomised controlled trial.SETTING:Neonatal Intensive Care Unit, Middlemore Hospital, Auckland, New Zealand.PATIENTS:120 preterm infants, <30 weeks' gestation at birth, stable on nCPAP for at least 48 hours.INTERVENTIONS:Infants underwent stratified randomisation to nHF 6 L/min or bubble CPAP 6 cm water. In both groups, stepwise weaning of their respiratory support over 96 hours according to a strict weaning protocol was carried out.MAIN OUTCOME MEASURES:Time on respiratory support from randomisation to 72 hours off respiratory support or 36 weeks' postmenstrual age. The non-inferiority threshold was set at 15%.RESULTS:59 infants were randomised to weaning using nHF and 61 using nCPAP. The groups were well balanced in regards to baseline demographics. The restricted mean duration of respiratory support following randomisation for the nCPAP group, using per-protocol analysis was 401 hours (upper boundary, mean plus 0.15, was 461 hours) and 375 hours in the nHF group (upper 95% CI 413 hours). nHF weaning was, therefore, non-inferior to nCPAP weaning at the non-inferiority threshold. There was no significant difference in time to discharge.CONCLUSION:For infants ready to wean from nCPAP, the CHiPS study found that nHF was non-inferior to discontinuing nCPAP at 5 cm water.TRIAL REGISTRATION NUMBER:Australia and New Zealand Clinical Trials Registry (ACTRN12615000077561).

Aims Central SBP (cSBP) was shown to be increased already in children with congenital heart disease (CHD). However, its development over time has not yet been investigated. The aim of this study was to evaluate the natural course of cSBP over time from longitudinal assessment in children with CHD. Methods In this longitudinal study, 306 children and adolescents (11.3 ± 2.9 years, 34% girls) with various CHD were prospectively examined from July 2014 to May 2022. Over a mean follow-up length of 30.1 ± 18.9 months, 467 follow-up assessments have been conducted. cSBP was noninvasively assessed by oscillometric measurement via Mobil-O-Graph. A linear mixed effect model was performed to examine the course of cSBP. Results cSBP increased significantly over time by 1.22 mmHg per year of age ( P < 0.001). The longitudinal increase in cSBP over time remained significant when including sex ( b = 0.68, P < 0.001), BMI ( b = 1.12, P < 0.001), hypertensive medication ( b = 1.13, P < 0.001), disease severity ( b = 1.04, P < 0.001), and CHD type ( b = 3.74, P = 0.03) in the model. Patients with transposition of the great arteries (TGA) after arterial switch had a significantly higher cSBP increase over time ( b = 1.78, P < 0.001). The longitudinal cSBP increase was significantly higher in obese CHD children ( b = 2.52, P = 0.005) and in boys ( b = 0.85, P < 0.001). Conclusion This study shows a longitudinal increase in cSBP in children with CHD. Whether observed trajectories of cSBP are normal or abnormal needs to be investigated in further studies. Monitoring of the vascular function with a special focus on patients with TGA and obese CHD children seems indicated.

OBJECTIVES:Clear outcome reporting in clinical trials facilitates accurate interpretation and application of findings and improves evidence-informed decision-making. Standardized core outcomes for reporting neonatal trials have been developed, but little is known about how primary outcomes are reported in neonatal trials. Our aim was to identify strengths and weaknesses of primary outcome reporting in recent neonatal trials. METHODS:Neonatal trials including ≥100 participants/arm published between 2015 and 2020 with at least 1 primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials' primary outcome reporting completeness using relevant items from Consolidated Standards of Reporting Trials 2010 and Consolidated Standards of Reporting Trials-Outcomes 2022 pertaining to the reporting of the definition, selection, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed. RESULTS:Outcome-reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity. CONCLUSIONS:Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neonatology. Use of existing outcome-reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials.

Nearly all very preterm infants will require some form of respiratory support in the neonatal unit. It is standard practice to humidify the inspired gases. It appears logical to bring this practice of humidification forward to the time immediately after birth. There is an evidence base for early provision of heated humidified gases in the delivery room, but because several forms of respiratory support may be needed (eg binasal prong CPAP and use of a T-piece resuscitator) this may be difficult to achieve. We describe a setup using a radiant warmer and humidification circuits to make this possible.

AIM:Socio-economic status (SES) and ethnicity have been associated with worse maternal and fetal outcomes. Counties Manukau is a region of New Zealand which has a high portion of the population living in areas of low SES and has a higher population of ethnic minorities (Pacific Islander, Asian and Maaori). To determine whether SES and ethnicity are associated with worse mortality and morbidity in preterm infants in Counties Manukau Hospital, New Zealand.METHODS:This retrospective cohort study compared the infants of mothers who live in the most deprived neighbourhoods to the infants of mothers who live in the least deprived neighbourhoods. Infants born between 2000 and 2019 were included if <30 weeks gestation or <1500 g and born in hospital. Primary outcome was combined mortality/morbidity.RESULTS:Univariate analysis showed demographic differences between the SES and ethnic groups, for example maternal age and maternal smoking. Using logistic regression, SES was not associated with worse neonatal outcomes for the most deprived SES (n = 624) compared to least deprived SES (n = 164). Ethnicity (n = 1326) was not associated with worse neonatal outcomes. Gestational age and maternal smoking were associated with neonatal mortality/morbidity; gestational age and antenatal steroids were associated with neonatal mortality. It was notable that the proportion of the study population in the less deprived groups used for the comparisons was relatively low.CONCLUSIONS:For preterm, in-hospital births in Counties Manukau over a 20-year period, neonatal outcomes were the same regardless of SES or ethnicity.

The life expectancy of patients with Tetralogy of Fallot (ToF) has increased in recent years. As a result, other risk factors with later onset in life are in the focus of patient care. Endothelial function is an early indicator of cardiovascular risk and was investigated along further structural vessel properties. A total of 17 patients (41.7 ± 7.1 years, 8 women) with Tetralogy of Fallot were 1:2 matched for sex with 34 (38.9 ± 8.1 years, 16 women) healthy volunteers. Participants received an assessment of their endothelial function and a structural assessment of the aorta. Patients with ToF showed a reduced endothelial function determined by reactive hyperaemia index after adjusting for age, weight and height (ToF: 1.55 ± 0.31 vs. controls: 1.84 ± 0.47; p = 0.023). No differences in carotid intima-media thickness (cIMT) between the ToF and healthy controls (ToF: 0.542 ± 0.063 mm vs. controls: 0.521 ± 0.164 mm; p = 0.319) were found. Patients with ToF had reduced vascular function compared to healthy subjects. As the structural component is not affected, endothelial dysfunction seems not to have yet manifested itself as a morphological change. Nevertheless, long-term management of these patients should include vascular parameters.

There are two recently completed large randomized clinical trials of blood transfusions in the preterm infants most at risk of requiring them. Liberal and restrictive strategies were compared with composite primary outcome measures of death and neurodevelopmental impairment. Infants managed under restrictive guidelines fared no worse in regard to mortality and neurodevelopment in early life. The studies had remarkably similar demographics and used similar transfusion guidelines. In both, there were fewer transfusions in the restrictive arm. Nevertheless, there were large differences between the studies in regard to transfusion exposure with almost 3 times the number of transfusions per participant in the transfusion of prematures (TOP) study. Associated with this, there were differences between the studies in various outcomes. For example, the combined primary outcome of death or neurodevelopmental impairment was more likely to occur in the TOP study and the mortality rate itself was considerably higher. Whilst the reasons for these differences are likely multifactorial, it does raise the question as to whether they could be related to the transfusions themselves? Clearly, every effort should be made to reduce exposure to transfusions and this was more successful in the Effects of Transfusion Thresholds on Neurocognitive Outcomes (ETTNO) study. In this review, we look at factors which may explain these transfusion differences and the differences in outcomes, in particular neurodevelopment at age 2 years. In choosing which guidelines to follow, centers using liberal guidelines should be encouraged to adopt more restrictive ones. However, should centers with more restrictive guidelines change to ones similar to those in the studies? The evidence for this is less compelling, particularly given the wide range of transfusion exposure between studies. Individual centers already using restrictive guidelines should assess the validity of the findings in light of their own transfusion experience. In addition, it should be remembered that the study guidelines were pragmatic and acceptable to a large number of centers. The major focus in these guidelines was on hemoglobin levels which do not necessarily reflect tissue oxygenation. Other factors such as the level of erythropoiesis should also be taken into account before deciding whether to transfuse.

Background Exclusive breastmilk is the desired enteral nutrition for babies born moderate- and late-preterm between 32+0 and 36+6 weeks' gestation; however, this goal is often difficult to achieve. Methods A prospective cohort of babies 32+0 −35+6 weeks' gestation enrolled in the DIAMOND trial were randomized to a condition specifying that babies should receive mother's own milk (MOM) as the only enteral feed. Factors associated with the successful transition to MOM, defined as MOM being the sole enteral feeding at the time of the first cessation of intravenous (IV) fluids, were investigated by logistic regression. Time to commencement of a milk other than MOM was analyzed by Kaplan–Meier survival curves. Results A total of 151 eligible babies (60% boys) were included, 93 (63%) of whom successfully transitioned from IV fluids onto MOM only. Alternative sources of milk, mostly formula, were used to transition from IV fluids onto enteral feeds more often in multiples and Māori, and was commenced earlier in Māori than other ethnicities (p = 0.007) and in late-preterm compared with moderate-preterm babies (p=0.01). Receiving exclusively breastmilk at discharge was more likely for babies who successfully transitioned from IV fluids onto MOM only [OR (95% confidence intervals) 4.9 (2.3–10.6)] and who received only MOM in the first week after birth [4.8 (2.2–10.4)], both p < 0.0001. Receiving breastmilk exclusively at discharge was less likely for Māori than Caucasian babies [0.2 (0.1–0.6), p < 0.0006]. There was no difference in the use of alternative sources of milk in babies who received parenteral nutrition or dextrose or between small-for-gestational-age and appropriate-for-gestational-age babies. Conclusions Despite an intention to provide only MOM, significant numbers of moderate- and late-preterm babies received formula to transition from IV fluids, and this differed by ethnicity. The drivers underlying these decisions require further investigation. These data highlight an urgent need for quality initiatives to support and encourage mothers of moderate- and late-preterm babies in their lactation.