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.
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
Parallel
Enhanced Standard of Care ("Enhanced")
Other interventionEnhanced Standard of Care ("Enhanced") will include: Educational Materials and Outreach, Local Champions, Train the Trainer, Local Simulation Training, and SA Starter Packs.
Enhanced Standard of Care ("Enhanced-Plus")
Other interventionEnhanced 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.
Penetration of early SA rescue
Proportion of eligible patients treated with SA as an early rescue device. Excludes SA after intubation attempt.
Initial adoption of early SA rescue
Quarters required to reach 10% penetration of SA use among eligible patients at hospital level
Sustainment of early SA rescue
Proportion of SA use among eligible patients per quarter examined using linear mixed effects model to quantitatively assess successful sustainment (slope of penetration proportion positive or not significantly different than 0) versus decay (slope of penetration negative) post-implementation.
Neonatal Intensive Care Unit (NICU) Admission
Proportion of any admission to Neonatal Intensive Care Unit (NICU) before hospital discharge at hospital level, assessed among patients ≥35 weeks' Gestational Age (GA)
Hypoxic Ischemic Encephalopathy (HIE)
Proportion of moderate to severe HIE at hospital level, assessed among patients ≥35 weeks' Gestational Age (GA)
Any exposure to Endotracheal Tube
Proportion of any exposure to ventilation through Endotracheal Tube (ETT) prior to hospital discharge, including during resuscitation, at hospital level
Hospital Mortality
Proportion of death before hospital discharge, at hospital level
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
