Effect of Continuous Positive Airway Pressure versus Free Flow Oxygen on Treatment Failure during Delivery Room Stabilization in Neonates more than or equal to 35 weeks : A Randomized Controlled Trial

Before the delivery of a potentially eligible neonate, the parents will be approached for consent. Eligible neonates will be enrolled after obtaining written informed consent from the parents. Consecutively born neonates will be screened for eligibility at birth. Resuscitation will proceed as per NRP guidelines 2025. Neonates who require PPV or intubation at birth will be excluded. Any neonate born at or more than 35 weeks who is spontaneously breathing with a heart rate of at least 100 bpm but develops RD in the DR meeting the eligibility criteria will be enrolled in the trial.

Neonates in both groups will be assessed by the treating team for clinical condition and need for any intervention in the DR. Any neonate with acute deterioration will be provided PPV or intubated as per NRP guidelines. Respiratory support will be escalated (PPV in CPAP group or CPAP in FFO group) if RD worsens or FiO2 requirement is more than 0.5 despite 30 minutes of intervention. Neonates with persistent RD or not able to maintain SpO2 more than 90% on room air at one hour of life will be admitted to the NICU. Neonates who improve in the DR (no signs of RD and maintaining SpO2 in the target range) will be shifted to mother-side for ongoing monitoring and routine newborn care.

Irrespective of the need for NICU admission, all neonates will undergo a LUS examination at 2 hours of life for quantitative LUS scoring and any evidence of pneumothorax. LUS clips will be recorded and assessed by an independent assessor who will be blinded to allocated intervention. LUS scoring will be done by the method described by Brat et al. During the same LUS examination, pneumothorax will be diagnosed on LUS based on the following findings: absence of lung sliding, absence of B lines, absence of lung pulse and presence of a lung point. Further, any neonate with clinical suspicion of pneumothorax in the NICU will undergo a chest x-ray (CXR) for detection. Therefore, pneumothorax will be noted in two ways, one based on USG findings (irrespective of symptoms) and the other based on CXR findings (symptomatic). Pneumothorax will be considered related to intervention if it occurs within 24 hours of life. The need and duration of invasive and non-invasive respiratory support in NICU and length of hospital stay will be noted for the enrolled neonates.