Recruiting

SA Rescue StrategiesSupraglottic Airway for Resuscitation Trial

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT07150923

Conditions

Neonatal Resuscitation

Delivery Room Resuscitation

Positive Pressure Ventilation

Infant, Newborn

Supraglottic Airway

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Enhanced Standard of Care ("Enhanced")

Enhanced Standard of Care ("Enhanced-Plus")

Study Details

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 resuscitation, with a focus on implementation outcomes.

Conditions

Neonatal Resuscitation

Delivery Room Resuscitation

Positive Pressure Ventilation

Infant, Newborn

Supraglottic Airway

Study ID

NCT07150923

Start date

Jan 1, 2026

Status verified date

Feb, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36503 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Enhanced Standard of Care ("Enhanced")

active comparator: Enhanced Standard of Care Plus Facilitation ("Enhanced-Plus")

Interventions

Enhanced 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.

Enhanced 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.

Primary outcome measure

Penetration of early SA rescue [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Elizabeth E Foglia, MD, MSCE

215-590-1653 foglia@chop.edu

Christopher P Bonafide, MD, MSCE

bonafide@chop.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Amy Mackay, MD

205-354-5008 amysessions@uabmc.edu

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Caroline Crocker, DO

512-656-8045 CECrocker@uams.edu

Lucile Packard Children's Hospital

Recruiting

Palo Alto, California, United States, 94304

Contacts

Arun Gupta, MD

650-248-4570 agup@stanford.edu

ChristianaCare

Recruiting

Newark, Delaware, United States, 19718

Contacts

Michael Favara, DO

302-932-4359 mfavara@christianacare.org

MaineHealth Mid Coast Hospital

Recruiting

Brunswick, Maine, United States, 04011

Contacts

Allison Zanno, MD

203-240-2955 Allison.zanno@mainehealth.org

MaineHealth Maine Medical Center

Recruiting

Portland, Maine, United States, 04102

Contacts

Allison Zanno, MD

203-240-2955 Allison.zanno@mainehealth.org

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Rachana Singh, MD, MS

413-847-1144 rsingh2@tuftsmedicalcenter.org

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Jane Brumbaugh, MD

651-260-5035 Brumbaugh.Jane@mayo.edu

Atrium Health Levine Children's Hospital

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Michelle Chiu, MD

704-281-8884 Michelle.chiu@atriumhealth.org

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Heidi Herrick, MD, MS

267-408-6146 herrickh@chop.edu

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19146

Contacts

Elizabeth E Foglia, MD, MSCE

267-441-7144 foglia@chop.edu

Parkland Health

Recruiting

Dallas, Texas, United States, 75235

Contacts

Vishal Kapadia, MD

214-648-3903 Vishal.Kapadia@UTSouthwestern.edu

Children's Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Ruby Gupta, MBBS, MS

262-312-4577 rgupta@mcw.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

Neonatal Resuscitation
Delivery Room Resuscitation
Positive pressure ventilation
Supraglottic Airway
Laryngeal Mask Airways
Implementation Research
Infant, Newborn

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-02-27.