Actively Recruiting

Phase Not Applicable
Age: 0Days +
All Genders
ID07150923

Comparing Two Strategies to Promote Supraglottic Airway Use During Neonatal Resuscitation

Led by Children's Hospital of Philadelphia · Updated on 2026-02-27

36503

Participants Needed

30

Research Sites

52 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital of Philadelphia

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two different strategies to increase the use of supraglottic airway (SA) devices during neonatal resuscitation. This trial focuses on improving early SA rescue for newborns who require help establishing breathing at birth. Despite SA being approved and recommended for cases where facemask ventilation is difficult, its use remains low, and the study aims to understand how to better implement SA use in routine care to reduce risks of prolonged asphyxia and improve newborn health outcomes. The trial compares two approaches to support hospitals and providers in adopting SA use. One group receives an Enhanced Standard of Care involving educational materials, outreach, local champions, train-the-trainer programs, simulation training, and starter packs of SA devices. The other group receives all these components plus additional intensive external facilitation to further promote SA adoption. These strategies are delivered at hospital sites and evaluated over time. Participants include hospital staff involved in newborn resuscitation and newborns who receive positive pressure ventilation at birth. Data collection includes questionnaires and interviews with clinical providers and administrators, along with monitoring early SA rescue rates up to two years. The study measures initial adoption and sustainment of SA use, assessing both implementation and clinical outcomes. The trial runs from 2026 to 2029 and aims to identify barriers and facilitators for widespread SA use in delivery rooms.

CONDITIONS

Brief Title

Supraglottic Airway for Resuscitation Trial

Who Can Participate

Age: 0Days +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Hospital staff employed full-time in newborn resuscitation roles
  • Hospital staff fluent in English
  • Newborns born in the hospital (inborn)
  • Newborns born at or after 34 weeks' gestation
  • Newborns who received positive pressure ventilation during neonatal resuscitation
Not Eligible

You will not qualify if you...

  • Newborns with congenital diaphragmatic hernia
  • Newborns with airway anomalies

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 2 years

Participants receive one of two enhanced standard of care strategies to promote the use of supraglottic airways during neonatal resuscitation.

Ongoing participation during clinical care; no additional scheduled visits

Long-term Monitoring

Duration - Up to 2 years

Participants are observed to assess the sustainment and penetration of early supraglottic airway rescue practices.

No additional visits; data collected through routine clinical care

Trial Site Locations

Total: 30 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Actively Recruiting

3

Sharp Chula Vista Medical Center

Chula Vista, California, United States, 91911

Not Yet Recruiting

4

Sharp Grossmont Hospital

La Mesa, California, United States, 91942

Not Yet Recruiting

5

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Not Yet Recruiting

6

Rady Children's NICU at Rancho Springs Medical Center

Murrieta, California, United States, 92562

Not Yet Recruiting

7

Lucile Packard Children's Hospital

Palo Alto, California, United States, 94304

Actively Recruiting

8

Jacobs Medical Center at University of California San Diego Health

San Diego, California, United States, 92037

Not Yet Recruiting

9

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, United States, 92123

Not Yet Recruiting

10

ChristianaCare

Newark, Delaware, United States, 19718

Actively Recruiting

11

St. John's Children's Hospital

Springfield, Illinois, United States, 62701

Not Yet Recruiting

12

Riley Hospital for Children

Indianapolis, Indiana, United States, 46202

Not Yet Recruiting

13

MaineHealth Mid Coast Hospital

Brunswick, Maine, United States, 04011

Actively Recruiting

14

MaineHealth Maine Medical Center

Portland, Maine, United States, 04102

Actively Recruiting

15

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Actively Recruiting

16

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

17

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Not Yet Recruiting

18

South Shore University Hospital

Bay Shore, New York, United States, 11706

Not Yet Recruiting

19

Lenox Hill Hospital

New York, New York, United States, 10075

Not Yet Recruiting

20

Cohen Children's Medical Center

Queens, New York, United States, 11040

Not Yet Recruiting

21

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Not Yet Recruiting

22

Atrium Health Levine Children's Hospital

Charlotte, North Carolina, United States, 28203

Actively Recruiting

23

Good Samaritan Hospital

Cincinnati, Ohio, United States, 45220

Not Yet Recruiting

24

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Not Yet Recruiting

25

Oklahoma Children's Hospital

Oklahoma City, Oklahoma, United States, 73104

Not Yet Recruiting

26

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

27

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19146

Actively Recruiting

28

Parkland Health

Dallas, Texas, United States, 75235

Actively Recruiting

29

Texas Children's Hospital

Houston, Texas, United States, 77030

Not Yet Recruiting

30

Children's Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

E

Elizabeth E Foglia, MD, MSCE

C

Christopher P Bonafide, MD, MSCE

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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