Status:
RECRUITING
Supraglottic Airway for Resuscitation Trial
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Neonatal Resuscitation
Delivery Room Resuscitation
Eligibility:
All Genders
Phase:
NA
Brief Summary
This is a hybrid type 3 effectiveness-implementation parallel cluster randomized superiority trial designed to compare two strategies to promote early supraglottic airway (SA) rescue during neonatal r...
Detailed Description
Each year, approximately 3.8 million infants are born in the United States, and up to 10% require resuscitation to establish breathing at birth. Positive pressure ventilation (PPV) is the most importa...
Eligibility Criteria
Inclusion
- 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
- 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
- Congenital diaphragmatic hernia
- Airway anomalies
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
36503 Patients enrolled
Trial Details
Trial ID
NCT07150923
Start Date
January 1 2026
End Date
September 1 2029
Last Update
January 7 2026
Active Locations (30)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Sharp Chula Vista Medical Center
Chula Vista, California, United States, 91911
4
Sharp Grossmont Hospital
La Mesa, California, United States, 91942