Delivery Room Intervention and Evaluation Network

NCT06803498 | Recruiting

• 1 other identifier: 21 FO 01
• Study Type: observational
• Target: 3,000,000
• Locations: 1 country
• Sites: 1

Brief Summary

The American Academy of Pediatrics (AAP) convened the multi-center Delivery Room Intervention and Evaluation (DRIVE) Network to establish essential infrastructure to collect, coordinate, and analyze core demographic, resuscitative, and outcome data for an inclusive and diverse population of infants who receive delivery room resuscitation at participating centers. The DRIVE Network consists of delivery hospitals across the United States, covering a range of geographic, urban/rural, racial/ethnic diversity across the country. Together, DRIVE seeks to compare practice-level delivery system characteristics, identify best practices, evaluate outcomes from various interventions, and promote professional development through dissemination via the wide reach of the Neonatal Resuscitation Program.

Conditions

Resuscitation; Infant, Newborn

Keywords

Continuous Positive Airway Pressure; Intermittent Positive Pressure Ventilation; Intubation, Intratracheal; Cardiopulmonary Resuscitation

Outcome Measures

Primary Outcomes (1)

• Patient disposition

  The disposition of the patient after resuscitation including newborn nursery, neonatal ICU including a special care nursery or transitional nursery, palliative care, or transfer to other hospital

  Immediately after the resuscitation intervention

Secondary Outcomes (1)

• In-hospital mortality

  Within 30 days after birth

Study Arms (1)

DRIVE Network Cohort

All infants who receive significant resuscitation intervention (CPAP, PPV, intubation, or CPR) at birth in a DRIVE Network member hospital.

Procedure: Receipt of significant resuscitation intervention at birth

Interventions

Receipt of significant resuscitation intervention at birth PROCEDURE

Receipt of CPAP, PPV, intubation, or CPR at birth in a hospital delivery room

DRIVE Network Cohort

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All inborn infants who receive significant intervention (CPAP, PPV, intubation, or CPR) at birth in a DRIVE member hospital are included in the DRIVE Database. In addition, summary data is also collected on monthly delivery volume at all sites (stratified by gestational age) to allow for more precise incidence estimates of resuscitative interventions.

You may qualify if:

• Inborn infant in receipt of a significant resuscitation intervention (CPAP, PPV, intubation, or CPR) at birth

You may not qualify if:

• Not live born

Sponsors & Collaborators

• American Academy of Pediatrics: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

American Academy of Pediatrics

Itasca, Illinois, 60143, United States

RECRUITING

Study Officials

• Elizabeth Foglia, MD MSCE MA FAAP

  Perelman School of Medicine at the University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Beena Kamath-Rayne, MD MPH FAAP

  American Academy of Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Goins

CONTACT

630-626-6289; bgoins@aap.org

Jessica Weglarz, MBA

CONTACT

630-626-6037; jweglarz@aap.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: January 1, 2022
• Primary Completion (Estimated): January 1, 2042
• Study Completion (Estimated): January 1, 2042
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Estimated to start in January 2025

Locations

US (1)