Using a supraglottic airway to help newborns breathe at birth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• Lucile Packard Children's Hospital
  Palo Alto, California, United States Recruiting
• ChristianaCare
  Newark, Delaware, United States Recruiting
• MaineHealth Mid Coast Hospital
  Brunswick, Maine, United States Recruiting
• MaineHealth Maine Medical Center
  Portland, Maine, United States Recruiting

Study contacts

• Principal investigator: Elizabeth E Foglia, MD, MSCE — Children's Hospital of Philadelphia
• Study coordinator: Elizabeth E Foglia, MD, MSCE
• Email: foglia@chop.edu
• Phone: 215-590-1653

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.