About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Major anomalies or aneuploidy
Palliative care planned or considered
Not resuscitated in the infant resuscitation room
Trial design
Treatments tested in this trial
- Supraglottic Airway