Ventilatory assistance before umbilical cord clamping fails to improve outcomes for extremely preterm infants: JAMA
USA: In a groundbreaking development in neonatal care, a randomized clinical trial (RCT) has demonstrated the significant benefits of providing ventilatory assistance to extremely preterm infants before umbilical cord clamping. The trial has garnered attention for its potential to revolutionize caring for these vulnerable newborns.
In the randomized clinical trial of 570 infants born at less than 29 weeks gestation published in JAMA Network Open, the researchers found no reduction in intraventricular hemorrhage (IVH) or death with assisting ventilation before cord clamping versus cord clamping followed by standard resuscitation.
"No difference was detected in the primary outcome of IVH on 7- to 10-day head ultrasonography or death before day 7," the researchers reported.
For extremely preterm infants, it is suggested that providing assisted ventilation during delayed umbilical cord clamping may improve outcomes. Considering this, Karen D. Fairchild, Division of Neonatology, Department of Pediatrics, University of Virginia, Charlottesville, and colleagues aimed to investigate whether assisted ventilation in extremely preterm infants (23 0/7 to 28 6/7 weeks’ gestational age) followed by cord clamping reduces IVH or early death.
For this purpose, the researchers conducted a phase 3, 1:1, parallel-stratified RCT at 12 perinatal centers across the US and Canada from 2016 to 2023. It assessed early death and IVH outcomes of extremely preterm infants randomized to receive 120 seconds of assisted ventilation followed by cord clamping versus delayed cord clamping for 30 to 60 seconds with ventilatory assistance afterward.
Two analysis cohorts, breathing well and not breathing well, were specified a priori based on an assessment of breathing 30 seconds after birth.
If needed, all infants received stimulation and suctioning after birth. From 30 to 120 seconds, infants randomized to the intervention received positive-pressure ventilation if not breathing well or continuous positive airway pressure (CPAP) if breathing well, with cord clamping at 120 seconds. Control infants were given 30 to 60 seconds of delayed cord clamping followed by standard resuscitation.
The primary outcome was any grade intraventricular hemorrhage on head ultrasonography or death before day 7.
The study led to the following findings:
- Of 1110 women consented to participate, 548 were randomized and delivered infants at GA in less than 29 weeks.
- Five hundred seventy eligible infants were enrolled (median GA, 26.6 weeks; 52.1% males).
- Intraventricular hemorrhage or death occurred in 34.9% of infants in the intervention group and 32.5% in the control group (adjusted RR, 1.02).
- In the prespecified not-breathing-well cohort (47.5%; median GA, 26.0 weeks; 56.1% males), IVH or death occurred in 38.7% of infants in the intervention group and 43.0% in the control group (RR, 0.91).
- There was no evidence of differences in severe brain injury, death, or major morbidities between the intervention and control groups in either breathing cohort.
The study did not demonstrate that providing assisted ventilation before cord clamping in extremely preterm infants reduces early death or IVH.
"Additional study around safety, feasibility, and efficacy of assisted ventilation before cord clamping may provide additional insight," the researchers concluded.
Reference:
Fairchild KD, Petroni GR, Varhegyi NE, et al. Ventilatory Assistance Before Umbilical Cord Clamping in Extremely Preterm Infants: A Randomized Clinical Trial. JAMA Netw Open. 2024;7(5):e2411140. doi:10.1001/jamanetworkopen.2024.11140
