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Using a supraglottic airway to help newborns breathe at birth

Comparing Two Multicomponent Strategies To Promote Supraglottic Airway Implementation During Neonatal Resuscitation

Not applicable Interventional Children's Hospital of Philadelphia · NCT07150923

This project will test whether teaching and equipping delivery teams to use a supraglottic airway helps newborns who need breathing support get effective ventilation sooner.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment36503 (estimated)
Ages0 Days and up
SexAll
SponsorChildren's Hospital of Philadelphia Academic / other
Locations30 sites (Birmingham, Alabama and 29 other locations)
Trial IDNCT07150923 on ClinicalTrials.gov

What this trial studies

This is a parallel cluster randomized superiority trial using a hybrid type 3 effectiveness–implementation design to compare two strategies (Enhanced vs Enhanced-Plus) to promote early supraglottic airway (SA) rescue during neonatal resuscitation. Hospitals are randomized as clusters and interventions target clinical providers and local leaders to change practice, with measurement of both implementation outcomes (adoption, fidelity, barriers) and clinical resuscitation outcomes. The trial focuses on real-world delivery-room care where positive pressure ventilation is needed and collects provider surveys, qualitative interviews, and clinical data on newborns who require assistance breathing at birth. The aim is to close the gap between existing evidence supporting SA use and routine practice by testing pragmatic implementation approaches across multiple U.S. hospitals.

Who should consider this trial

Good fit: Ideal candidates are newborn infants who require positive pressure ventilation at birth in participating delivery units.

Not a fit: Infants who breathe effectively at birth or those born outside participating hospitals would not be affected by the interventions tested in this trial.

Why it matters

Potential benefit: If successful, earlier and more reliable use of supraglottic airways could shorten delays in effective ventilation and reduce complications from birth asphyxia.

How similar studies have performed: Supraglottic airways are FDA-approved and supported by prior clinical studies and international guidelines as a safe, effective alternative to facemask or intubation, but trials specifically testing strategies to increase routine use are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Population 1: Hospital Staff

Population 1a: Clinical providers and administrators who complete study questionnaires

Clinical provider 1a inclusion criteria:

* Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation
* Fluent in English

Administrator 1a inclusion criteria

* Oversee the care of newborns on a local level (e.g. nurse manager) or a hospital level (e.g. Chief Quality and Safety Officer)
* Fluent in English

Clinical provider and administrator exclusion 1a criteria: No exclusion criteria

Population 1b: Clinical providers who participate in qualitative interviews

Clinical provider 1b inclusion criteria:

* Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation
* Fluent in English

Clinical provider 1b exclusion criteria: No exclusion criteria

Population 2: Patients who receive neonatal resuscitation at birth

Inclusion Criteria:

* Inborn (not transferred to the hospital after birth)
* ≥34 weeks' gestation at birth, based on best obstetrical estimate
* Received PPV during neonatal resuscitation (as per provider's clinical assessment)

Exclusion Criteria:

* Congenital diaphragmatic hernia
* Airway anomalies

Where this trial is running

Birmingham, Alabama and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neonatal ResuscitationDelivery Room ResuscitationPositive Pressure VentilationInfant, NewbornSupraglottic AirwayLaryngeal Mask AirwaysImplementation ResearchPositive pressure ventilation
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.