About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Enhanced Standard of Care ("Enhanced")
  • Enhanced Standard of Care ("Enhanced-Plus")

Treatment groups

36,503 Participants
are divided into 2 treatment groups

Locations

30
Alabama
University of Alabama at Birmingham35294, Birmingham United States
Arkansas
University of Arkansas for Medical Sciences72205, Little Rock United States
California
Sharp Chula Vista Medical Center91911, Chula Vista United States
Sharp Grossmont Hospital91942, La Mesa United States

Sponsors and collaborators

Children's Hospital of Philadelphia

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator