NCT07419438

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

January 5, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

March 13, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

January 5, 2026

Last Update Submit

April 16, 2026

Conditions

Respiratory FailurePremature NeonatesDelivery Room ResuscitationPositive Pressure VentilationNeonatal ResuscitationSupraglottic AirwayLaryngeal MaskLaryngeal Mask Airways

Keywords

Respiratory failurePremature neonatesDelivery Room ResuscitationPositive pressure ventilationNeonatal resuscitationSupraglottic Airwaylaryngeal maskLaryngeal Mask Airways

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Time to Supraglottic Airway Placement During Resuscitation

    Immediately after birth

  • Duration of Supraglottic Airway Use During Resuscitation

    Immediately after birth

Other Outcomes (3)

  • Heart Rate During Resuscitation and First 24 Hours of Life

    Birth to 24 hours of life

  • Oxygen Saturation During Resuscitation and First 24 Hours of Life

    Birth to 24 hours of life

  • Need for Advanced Cardiorespiratory Interventions Within 24 Hours of Birth

    Birth to 24 hours of life

Study Arms (1)

Supraglottic Airway

EXPERIMENTAL

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

Interventions

Supraglottic AirwayOTHER

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

Supraglottic Airway

Eligibility Criteria

Age0 Days - 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Central Study Contacts

Sura Lee

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

February 19, 2026

Study Start

March 13, 2026

Primary Completion

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)