Comparing Manual T-Piece Versus Ventilator Positive Pressure Ventilation for Breathing Support in Extremely Premature Newborns During First 10 Minutes After Birth

What this Trial Is About

This clinical trial focuses on extremely premature infants born between 25 and 28 weeks of gestation who require immediate breathing support after birth. Researchers aim to compare two methods of providing positive pressure ventilation PPV during the first 10 minutes after birth the manual T-piece resuscitator and a ventilator-delivered PPV V-PPV using nasal intermittent positive pressure ventilation NIPPV. The study seeks to evaluate the impact of these methods on major health complications or death, providing insights to improve care during this critical transition period for these vulnerable newborns. Participants will receive PPV either by a T-piece resuscitator connected to a face mask or by a neonatal ventilator in NIPPV mode connected to a nasal mask or prongs. Both methods will have adjustable settings standardized across study sites. The ventilation support is provided during the first 10 minutes after birth, with each site randomized to use one of the PPV methods. This approach may refine respiratory support and potentially reduce the need for invasive procedures like intubation. During the study, infants will be monitored from enrollment through study completion, up to 50 weeks postmenstrual age. Researchers will assess outcomes including pre-discharge mortality, major neuro-injury, and moderate to severe bronchopulmonary dysplasia BPD. Additional measurements include advanced resuscitation needs, duration of mechanical ventilation, and discharge on home oxygen. The study will track these health outcomes and safety measures to better understand the effects of the PPV methods over time.

Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates