With or Without Nasal Continuous Positive Airway Pressure During Delayed Cord Clamping in Premature Infants <32 Weeks: A Randomized Controlled Trial Using an Intention-To-Treat Analysis

OBJECTIVE: To assess whether providing nasal continuous positive airway pressure (nCPAP) during delayed cord clamping is beneficial for preterm infants <32 weeks. STUDY DESIGN: A randomized controlled trial was performed from March 2020 to May 2021. Premature infants (<32 weeks of gestational age; n = 160) were allocated to receive at least 60 s of delayed cord clamping with nCPAP (DCC+nCPAP; n = 80) or without nCPAP (DCC only; n = 80). For both groups, after the umbilical cord was clamped, the infants were carried immediately to the resuscitation room to continue receiving standard transition. The primary outcome was the mechanical ventilation (MV) rate within 24 h of life. The measurements related to early respiratory support effect before cord clamping including positive end-expiratory pressure (PEEP) and FiO(2) during transition/leaving the delivery room, intubation rate during transition, pulmonary surfactant (PS) administration ≥2 times after birth, extubation failure, and incidence of bronchopulmonary dysplasia (BPD) were collected as the secondary outcomes. Furthermore, other neonatal short-term outcomes and safety assessment were also included. RESULTS: The measurements were calculated using intention-to-treat analysis. The median time for cord clamping were 60 s with interquartile range (IQR) (60.00–60.00 vs. 60.00–70.00) in both groups. There were no difference in the primary outcome of MV rate within 24 h of life (p = 0.184). The arterial blood gas pH at 1 h after birth in the DCC+nCPAP group was 7.28 ± 0.08 vs. 7.25 ± 0.07 in the control group (mean difference = 0.01, 95% CI: −0.01–0.05, p = 0.052), which approached statistical significance. There was no significant statistical difference in the other short-term neonatal outcomes and the safety indicators between the two groups. CONCLUSIONS: Our study showed that delayed cord clamping with nCPAP was feasible and safe in preterm infants with gestational age <32 weeks. Although there was a trend toward a higher arterial blood gas pH at 1 h after birth in the DCC+nCPAP group, DCC+nCPAP neither resulted in a corresponding measurable clinical improvement nor did it reduce subsequent neonatal morbidity. A larger multi-center study including more infants with gestational age <28 weeks is needed to evaluate the full effects of DCC in combination with nCPAP in preterm infants.