Actively Recruiting
Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial
Led by University of Pennsylvania · Updated on 2026-04-17
20
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using a supraglottic airway (SA) as the main interface for positive pressure ventilation (PPV) is feasible during delivery room resuscitation in premature infants born between 29 0/7 and 33 6/7 weeks' gestation. The study aims to determine if this method can effectively provide ventilation immediately after birth in these infants who require resuscitation. The study involves a single group of premature infants who need PPV at birth. These infants will receive ventilation through a supraglottic airway as the primary airway interface during delivery room resuscitation. The intervention is applied immediately after birth if resuscitation is required, focusing on the placement and use of the supraglottic airway. Participants will be screened before birth with parental consent obtained, then reassessed for eligibility at delivery. Clinical and procedural data will be collected during resuscitation and for up to 24 hours after birth. Researchers will measure the feasibility of using the supraglottic airway as the primary ventilation interface within the first 10 minutes of life, along with the timing and duration of airway placement during resuscitation.
CONDITIONS
Brief Title
Supraglottic Airway for Resuscitation in Preemies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age 29 0/7 to 33 6/7 weeks at birth
- Estimated fetal weight greater than or equal to 1000 grams at birth
- Clinical decision to initiate positive pressure ventilation
- Parental informed consent obtained
You will not qualify if you...
- Major anomalies or chromosomal abnormalities
- Planned or considered palliative care
- Infant not resuscitated in the infant resuscitation room
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 10 minutes immediately after birth
Participants receive positive pressure ventilation through a supraglottic airway as the primary airway interface immediately after birth during delivery room resuscitation.
1 delivery room visit
Trial Site Locations
Total: 1 location
1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
S
Sura Lee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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