Supraglottic Airway for Resuscitation Trial

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT07150923
Status
Recruiting
Apply to this trial

Conditions

  • Delivery Room Resuscitation
  • Implementation Research
  • Infant, Newborn
  • Laryngeal Mask Airways
  • Neonatal Resuscitation
  • Positive Pressure Ventilation
  • Supraglottic Airway

Eligibility Criteria

Sex
ALL
Age
0 Days - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enhanced Standard of Care ("Enhanced") — OTHER
    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") — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
36,503 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Enhanced Standard of Care ("Enhanced")
  • Active Comparator: Enhanced Standard of Care Plus Facilitation ("Enhanced-Plus")

Primary Outcome Measure

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

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Amy Mackay, MD
[email protected]
205-354-5008
University of Arkansas for Medical SciencesLittle RockArkansas72205
Caroline Crocker, DO
[email protected]
512-656-8045
Sharp Chula Vista Medical CenterChula VistaCalifornia91911
Anup Katheria, MD, MS
[email protected]
858-900-1219
Sharp Grossmont HospitalLa MesaCalifornia91942
Anup Katheria, MD, MS
[email protected]
858-900-1219
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Manoj Biniwale, MD
[email protected]
424-832-9724
Rady Children's NICU at Rancho Springs Medical CenterMurrietaCalifornia92562
Richard Song, MD
[email protected]
773-620-3025
Lucile Packard Children's HospitalPalo AltoCalifornia94304
Arun Gupta, MD
[email protected]
650-248-4570
Jacobs Medical Center at University of California San Diego HealthSan DiegoCalifornia92037
Pamela Del Rosario, MD
[email protected]
858-249-1702
Sharp Mary Birch Hospital for Women & NewbornsSan DiegoCalifornia92123
Anup Katheria, MD
[email protected]
858-900-1219
ChristianaCareNewarkDelaware19718
Michael Favara, DO
[email protected]
302-932-4359
St. John's Children's HospitalSpringfieldIllinois62701
Mohamed F Ahamed, MD
[email protected]
917-969-1981
Riley Hospital for ChildrenIndianapolisIndiana46202
Elizabeth Wetzel, MD, MS
[email protected]
317-679-0327
MaineHealth Mid Coast HospitalBrunswickMaine04011
Allison Zanno, MD
[email protected]
203-240-2955
MaineHealth Maine Medical CenterPortlandMaine04102
Allison Zanno, MD
[email protected]
203-240-2955
Tufts Medical CenterBostonMassachusetts02111
Rachana Singh, MD, MS
[email protected]
413-847-1144
Mayo ClinicRochesterMinnesota55905
Jane Brumbaugh, MD
[email protected]
651-260-5035
Hackensack University Medical CenterHackensackNew Jersey07601
Nicole Spillane, MD
[email protected]
917-446-6656
South Shore University HospitalBay ShoreNew York11706
Naomi Cohen, MD
[email protected]
212-434-4952
Lenox Hill HospitalNew YorkNew York10075
Naomi Cohen, MD
[email protected]
212-434-4952
Cohen Children's Medical CenterQueensNew York11040
Naomi Cohen, MD
[email protected]
212-434-4952
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Jackie Patterson, MD, MPH
[email protected]
919-608-2853
Atrium Health Levine Children's HospitalCharlotteNorth Carolina28203
Michelle Chiu, MD
[email protected]
704-281-8884
Good Samaritan HospitalCincinnatiOhio45220
Morgan Hill, MD
[email protected]
513-276-1929
Nationwide Children's HospitalColumbusOhio43205
Cecilie Halling, MD
[email protected]
469-404-6583
Oklahoma Children's HospitalOklahoma CityOklahoma73104
Birju A Shah, MD, MBA, MPH
[email protected]
201-496-8383
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19146
Elizabeth E Foglia, MD, MSCE
[email protected]
267-441-7144
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Heidi Herrick, MD, MS
[email protected]
267-408-6146
Parkland HealthDallasTexas75235
Vishal Kapadia, MD
[email protected]
214-648-3903
Texas Children's HospitalHoustonTexas77030
Nathan C Sundgren, MD, PhD
[email protected]
214-770-9142
Children's WisconsinMilwaukeeWisconsin53226
Ruby Gupta, MBBS, MS
[email protected]
262-312-4577

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University of Alabama at Birmingham· Birmingham, ALUniversity of Arkansas for Medical Sciences· Little Rock, ARSharp Chula Vista Medical Center· Chula Vista, CASharp Grossmont Hospital· La Mesa, CACedars-Sinai Medical Center· Los Angeles, CARady Children's NICU at Rancho Springs Medical Center· Murrieta, CA

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