Actively Recruiting

Phase Not Applicable
Age: 0Days - 1Day
All Genders
ID07419438

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

Age: 0Days - 1Day
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

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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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