Physiologically based cord clamping for infants ≥32+0 weeks gestation: A randomised clinical trial and reference percentiles for heart rate and oxygen saturation for infants ≥35+0 weeks gestation.

BACKGROUND: Globally, the majority of newborns requiring resuscitation at birth are full term or late-preterm infants. These infants typically have their umbilical cord clamped early (ECC) before moving to a resuscitation platform, losing the potential support of the placental circulation. Physiologically based cord clamping (PBCC) is clamping the umbilical cord after establishing lung aeration and holds promise as a readily available means of improving early newborn outcomes. In mechanically ventilated lambs, PBCC improved cardiovascular stability and reduced hypoxia. We hypothesised that PBCC compared to ECC would result in higher heart rate (HR) in infants needing resuscitation, without compromising safety. METHODS AND FINDINGS: Between 4 July 2018 and 18 May 2021, infants born at ≥32+0 weeks' gestation with a paediatrician called to attend were enrolled in a parallel-arm randomised trial at 2 Australian perinatal centres. Following initial stimulation, infants requiring further resuscitation were randomised within 60 seconds of birth using a smartphone-accessible web link. The intervention (PBCC) was to establish lung aeration, either via positive pressure ventilation (PPV) or effective spontaneous breathing, prior to cord clamping. The comparator was early cord clamping (ECC) prior to resuscitation. The primary outcome was mean HR between 60 to 120 seconds after birth, measured using 3-lead electrocardiogram, extracted from video recordings blinded to group allocation. Nonrandomised infants had deferred cord clamping (DCC) ≥120 seconds in the observational study arm. Among 508 at-risk infants enrolled, 123 were randomised (n = 63 to PBCC, n = 60 to ECC). Median (interquartile range, IQR) for gestational age was 39.9 (38.3 to 40.7) weeks in PBCC infants and 39.6 (38.4 to 40.4) weeks in ECC infants. Approximately 49% and 50% of the PBCC and ECC infants were female, respectively. Five infants (PBCC = 2, ECC = 3, 4% total) had missing primary outcome data. Cord clamping occurred at a median (IQR) of 136 (126 to 150) seconds in the PBCC arm and 37 (27 to 51) seconds in the ECC arm. Mean HR between 60 to 120 seconds after birth was 154 bpm (beats per minute) for PBCC versus 158 bpm for ECC (adjusted mean difference -6 bpm, 95% confidence interval (CI) -17 to 5 bpm, P = 0.39). Among 31 secondary outcomes, postpartum haemorrhage ≥500 ml occurred in 34% and 32% of mothers in the PBCC and ECC arms, respectively. Two hundred ninety-five nonrandomised infants (55% female) with median (IQR) gestational age of 39.6 (38.6 to 40.6) weeks received DCC. Data from these infants was used to create percentile charts of expected HR and oxygen saturation in vigorous infants receiving DCC. The trial was limited by the small number of infants requiring prolonged or advanced resuscitation. PBCC may provide other important benefits we did not measure, including improved maternal-infant bonding and higher iron stores. CONCLUSIONS: In this study, we observed that PBCC resulted in similar mean HR compared to infants receiving ECC. The findings suggest that for infants ≥32+0 weeks' gestation who receive brief, effective resuscitation at closely monitored births, PBCC does not provide additional benefit over ECC (performed after initial drying and stimulation) in terms of key physiological markers of transition. PBCC was feasible using a simple, low-cost strategy at both cesarean and vaginal births. The percentile charts of HR and oxygen saturation may guide clinicians monitoring the transition of at-risk infants who receive DCC. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000621213.

Baby-directed umbilical cord clamping: A feasibility study.

INTRODUCTION: Over five percent of infants born worldwide will need help breathing after birth. Delayed cord clamping (DCC) has become the standard of care for vigorous infants. DCC in non-vigorous infants is uncommon because of logistical difficulties in providing effective resuscitation during DCC. In Baby-Directed Umbilical Cord Clamping (Baby-DUCC), the umbilical cord remains patent until the infant's lungs are exchanging gases. We conducted a feasibility study of the Baby-DUCC technique. METHODS: We obtained antenatal consent from pregnant women to enroll infants born at ≥32 weeks. Vigorous infants received ≥2 min of DCC. If the infant received respiratory support, the umbilical cord was clamped ≥60 s after the colorimetric carbon dioxide detector turned yellow. Maternal uterotonic medication was administered after umbilical cord clamping. A paediatrician and researcher entered the sterile field to provide respiratory support during a cesarean birth. Maternal and infant outcomes in the delivery room and prior to hospital discharge were analysed. RESULTS: Forty-four infants were enrolled, 23 delivered via cesarean section (8 unplanned) and 15 delivered vaginally (6 via instrumentation). Twelve infants were non-vigorous. ECG was the preferred method for recording HR. Two infants had a HR < 100 BPM. All HR values were >100 BPM by 80 s after birth. Median time to umbilical cord clamping was 150 and 138 s in vigorous and non-vigorous infants, respectively. Median maternal blood loss was 300 ml. CONCLUSIONS: It is feasible to provide resuscitation to term and near-term infants during DCC, after both vaginal and cesarean births, clamping the umbilical cord only when the infant is physiologically ready.

Free-flow oxygen delivery to newly born infants.

Resuscitation guidelines recommend administration of free-flow oxygen to newly born infants who breathe but remain cyanosed. Self-inflating resuscitation bags are described as unreliable for this purpose. We measured oxygen concentrations >or=80% delivered through a 240 mL Laerdal self-inflating resuscitation bag and from 5 mm tubing inside a cupped hand.