Supraglottic Airway for Resuscitation in Preemies

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07419438
Status
Recruiting
Apply to this trial

Conditions

  • Delivery Room Resuscitation
  • Laryngeal Mask
  • Laryngeal Mask Airways
  • Neonatal Resuscitation
  • Positive Pressure Ventilation
  • Premature Neonates
  • Respiratory Failure
  • Supraglottic Airway

Eligibility Criteria

Sex
ALL
Age
0 Days - 1 Day
Healthy Volunteers
Not accepted

Interventions

  • Supraglottic Airway — OTHER
    Use of a supraglottic airway as the primary interface for delivery of positive pressure ventilation during neonatal resuscitation.

Study Details

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.

Key Dates

Start date
Mar 13, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Feasibility of Supraglottic Airway as Primary Ventilation Interface [ Time Frame: Immediately after birth (up to 10 minutes of life) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Sura Lee
[email protected]
215-873-9339

Find similar trials in Philadelphia, PA

By research site
Hospital of the University of Pennsylvania· Philadelphia, PA

Related Studies