RecruitingNot ApplicableNCT07419438

Supraglottic Airway for Resuscitation in Preemies

Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial


Sponsor

University of Pennsylvania

Enrollment

20 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 0 DaysMax Age: 1 Day

Inclusion Criteria4

  • 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

Exclusion Criteria3

  • Major anomalies or aneuploidy
  • Palliative care planned or considered
  • Not resuscitated in the infant resuscitation room

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Interventions

OTHERSupraglottic Airway

Use of a supraglottic airway as the primary interface for delivery of positive pressure ventilation during neonatal resuscitation.


Locations(1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT07419438


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