Recruiting

Supraglottic Airway

Sponsor:

University of Pennsylvania

Code:

NCT07419438

Conditions

Respiratory Failure

Premature Neonates

Delivery Room Resuscitation

Positive Pressure Ventilation

Neonatal Resuscitation

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Supraglottic Airway

Study Details

Brief 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.

Conditions

Respiratory Failure

Premature Neonates

Delivery Room Resuscitation

Positive Pressure Ventilation

Neonatal Resuscitation

Study ID

NCT07419438

Start date

Mar 13, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Supraglottic Airway

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

Central contacts

Sura Lee

215-873-9339sura.lee@pennmedicine.upenn.edu

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Sura Lee

215-873-9339sura.lee@pennmedicine.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Respiratory failure
  • Premature neonates
  • Delivery Room Resuscitation
  • Positive pressure ventilation
  • Neonatal resuscitation
  • Supraglottic Airway
  • laryngeal mask
  • Laryngeal Mask Airways

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-07-14.