The goal of this single-arm intervention trial is to learn whether using a supraglottic airway (SA) as the primary interface for positive pressure ventilation (PPV) is feasible during delivery room resuscitation of premature infants. This study will be conducted in premature infants born between 29 0/7 and 33 6/7 weeks' gestation who require PPV at birth.
The main question it aims to answer is: Is it feasible to use a supraglottic airway as the primary interface to provide effective PPV during delivery room resuscitation in 29 0/7 to 33 6/7 weeks' gestation premature infants?
Participants will (1)Be screened prenatally and have informed consent obtained from the birth parent prior to delivery; (2)Be rescreened for eligibility on the day of delivery before receiving the study intervention; (3)Receive PPV using a supraglottic airway as the primary ventilation interface if resuscitation is required at birth; and (4)Have clinical and procedural data collected during delivery room resuscitation and for up to 24 hours after birth.
Gestational age 29 0/7 to 33 6/7 weeks at birth
Estimated fetal weight >/= 1000 grams at birth
Clinical decision to initiate PPV
Parental informed consent
Major anomalies or aneuploidy
Palliative care planned or considered
Not resuscitated in the infant resuscitation room
Single group
Supraglottic Airway
Other interventionUse of a supraglottic airway as the primary interface for delivery of positive pressure ventilation during neonatal resuscitation.
Feasibility of Supraglottic Airway as Primary Ventilation Interface
Feasibility defined as successful use of a supraglottic airway as the primary interface to deliver positive pressure ventilation for up to 10 minutes of life or until discontinuation of positive pressure ventilation, without need for immediate escalation to an alternative airway interface.
Time to Supraglottic Airway Placement During Resuscitation
Time in minutes from birth to placement of the supraglottic airway as the primary interface for delivery of positive pressure ventilation during delivery room resuscitation.
Duration of Supraglottic Airway Use During Resuscitation
Total duration in minutes that the supraglottic airway is used as the primary interface to deliver positive pressure ventilation during delivery room resuscitation.
Heart Rate During Resuscitation and First 24 Hours of Life
Heart rate measured in beats per minute (bpm) using continuous cardiorespiratory monitoring during neonatal resuscitation and within the first 24 hours after birth.
Oxygen Saturation During Resuscitation and First 24 Hours of Life
Peripheral oxygen saturation (SpO₂), measured as a percentage using pulse oximetry during neonatal resuscitation and within the first 24 hours after birth.
Need for Advanced Cardiorespiratory Interventions Within 24 Hours of Birth
Occurrence of cardiorespiratory interventions including endotracheal intubation, chest compressions, administration of epinephrine, or initiation of mechanical ventilation during resuscitation or within the first 24 hours after birth, recorded as yes/no.
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