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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 1 day
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Sura Lee
sura.lee@pennmedicine.upenn.edu
215-873-9339
Time Frame
Start Date: 2026-02
Estimated Completion Date: 2026-10
Participants
Target number of participants: 20
Treatments
Experimental: Supraglottic Airway
Premature infants who require positive pressure ventilation immediately after birth will receive ventilation through a supraglottic airway used as the primary airway interface during delivery room resuscitation.
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov