RecruitingNot ApplicableNCT07150923

Supraglottic Airway for Resuscitation Trial

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


Sponsor

Children's Hospital of Philadelphia

Enrollment

36,503 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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 resuscitation, with a focus on implementation outcomes.


Eligibility

Min Age: 0 Days

Inclusion Criteria11

  • Population 1: Hospital Staff
  • Population 1a: Clinical providers and administrators who complete study questionnaires
  • Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation
  • Fluent in English
  • 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
  • Employed full-time by the hospital, affiliated practice, or affiliated university in a role that involves newborn resuscitation
  • Fluent in English
  • 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 Criteria4

  • Population 1b: Clinical providers who participate in qualitative interviews
  • Population 2: Patients who receive neonatal resuscitation at birth
  • Congenital diaphragmatic hernia
  • Airway anomalies

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Interventions

OTHEREnhanced Standard of Care ("Enhanced")

Enhanced Standard of Care ("Enhanced") will include: Educational Materials and Outreach, Local Champions, Train the Trainer, Local Simulation Training, and SA Starter Packs.

OTHEREnhanced Standard of Care ("Enhanced-Plus")

Enhanced Standard of Care ("Enhanced-Plus") will include: Educational Materials and Outreach, Local Champions, Train the Trainer, Local Simulation Training, SA Starter Packs, and three additional intensive external facilitation components.


Locations(30)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Sharp Chula Vista Medical Center

Chula Vista, California, United States

Sharp Grossmont Hospital

La Mesa, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Rady Children's NICU at Rancho Springs Medical Center

Murrieta, California, United States

Lucile Packard Children's Hospital

Palo Alto, California, United States

Jacobs Medical Center at University of California San Diego Health

San Diego, California, United States

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, United States

ChristianaCare

Newark, Delaware, United States

St. John's Children's Hospital

Springfield, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

MaineHealth Mid Coast Hospital

Brunswick, Maine, United States

MaineHealth Maine Medical Center

Portland, Maine, United States

Tufts Medical Center

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

South Shore University Hospital

Bay Shore, New York, United States

Lenox Hill Hospital

New York, New York, United States

Cohen Children's Medical Center

Queens, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Atrium Health Levine Children's Hospital

Charlotte, North Carolina, United States

Good Samaritan Hospital

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Oklahoma Children's Hospital

Oklahoma City, Oklahoma, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Parkland Health

Dallas, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Children's Wisconsin

Milwaukee, Wisconsin, United States

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NCT07150923


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