Supraglottic Airway for Resuscitation in Preemies (SUPREEMIE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Supraglottic Airway; Neonatal Resuscitation; Laryngeal Mask; Premature Neonates; Delivery Room Resuscitation; Positive Pressure Ventilation; Laryngeal Mask Airways
• Intervention / Treatment: Other: Supraglottic Airway

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sura Lee; Phone Number: 215-873-9339; Email: sura.lee@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Contact: Sura Lee; Phone Number: 215-873-9339; Email: sura.lee@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Supraglottic Airway; Use of a supraglottic airway as the primary interface for delivery of positive pressure ventilation during neonatal resuscitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Supraglottic Airway as Primary Ventilation Interface	Feasibility defined as successful use of a supraglottic airway as the primary interface to deliver positive pressure ventilation for up to 10 minutes of life or until discontinuation of positive pressure ventilation, without need for immediate escalation to an alternative airway interface.	Immediately after birth (up to 10 minutes of life)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Supraglottic Airway Placement During Resuscitation	Time in minutes from birth to placement of the supraglottic airway as the primary interface for delivery of positive pressure ventilation during delivery room resuscitation.	Immediately after birth
Duration of Supraglottic Airway Use During Resuscitation	Total duration in minutes that the supraglottic airway is used as the primary interface to deliver positive pressure ventilation during delivery room resuscitation.	Immediately after birth

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate During Resuscitation and First 24 Hours of Life	Heart rate measured in beats per minute (bpm) using continuous cardiorespiratory monitoring during neonatal resuscitation and within the first 24 hours after birth.	Birth to 24 hours of life
Oxygen Saturation During Resuscitation and First 24 Hours of Life	Peripheral oxygen saturation (SpO₂), measured as a percentage using pulse oximetry during neonatal resuscitation and within the first 24 hours after birth.	Birth to 24 hours of life
Need for Advanced Cardiorespiratory Interventions Within 24 Hours of Birth	Occurrence of cardiorespiratory interventions including endotracheal intubation, chest compressions, administration of epinephrine, or initiation of mechanical ventilation during resuscitation or within the first 24 hours after birth, recorded as yes/no.	Birth to 24 hours of life

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Respiratory failure; laryngeal mask; Neonatal resuscitation; Positive pressure ventilation; Supraglottic Airway; Premature neonates; Delivery Room Resuscitation; Laryngeal Mask Airways
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 857967

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No