Delivery Room Intervention and Evaluation Network (DRIVE Network)

Delivery Room Intervention and Evaluation (DRIVE) Network

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.

Study Overview

• Status: Recruiting
• Conditions: Resuscitation; Infant, Newborn
• Intervention / Treatment: Procedure: Receipt of significant resuscitation intervention at birth

Detailed Description

Basic neonatal resuscitation, which includes drying, warmth, stimulation, suctioning of the baby's nose/mouth as needed, and PPV, comprise the essential skills to which 95% of babies will respond and breathe, yet more data are collected about advanced resuscitative measures that occur in only 3-5% of deliveries. Existing neonatal networks and registries focus on high-risk and premature infants and are not all-inclusive of newborn babies and the basic neonatal resuscitation interventions which save the most lives, but about which little data have been collected in a standardized way. Studying quality of care at birth is also important as it is well known that there is variation between centers, as well as long-standing disparities in infant mortality in the United States.

The objective of this project is to establish essential infrastructure to collect and coordinate core demographic, resuscitative, and outcome variables in an inclusive and diverse population of infants at participating centers. The overarching goal is to relay data back to individual centers, benchmarking their own results against the entire network. Individual centers can employ quality improvement techniques to target professional development activities and improve resuscitation practices. AAP would also use these data to continually improve the educational framework around NRP. Additionally, external investigators could also submit proposals to query the network database on important research questions involving neonatal resuscitation.

• Study Type: Observational
• Enrollment (Estimated): 3000000

Contacts and Locations

• Study Contact: Name: Beth Goins; Phone Number: 630-626-6289; Email: bgoins@aap.org
• Study Contact Backup: Name: Jessica Weglarz, MBA; Phone Number: 630-626-6037; Email: jweglarz@aap.org

Study Locations

• United States
  • Illinois
    • Itasca, Illinois, United States, 60143
      • Recruiting
      • American Academy of Pediatrics
      • Contact: Beth Goins; Phone Number: (630) 626-6289; Email: bgoins@aap.org
      • Contact: Beena Kamath-Rayne, MD MPH FAAP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Not live born

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Receipt of CPAP, PPV, intubation, or CPR at birth in a hospital delivery room

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	Whether the patient died following resuscitation	Within 30 days after birth

Collaborators and Investigators

• Sponsor: American Academy of Pediatrics
• Collaborators: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): January 1, 2042
• Study Completion (Estimated): January 1, 2042

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Cardiopulmonary Resuscitation; Intubation, Intratracheal; Intermittent Positive Pressure Ventilation
• Other Study ID Numbers: 21 FO 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For investigators interested in using DRIVE data for observational research, research proposals will be accepted, reviewed, and approved by the DRIVE Steering Committee. Once appropriate regulatory and data use agreements are in place, fully de-identified analytic datasets will be shared for approved protocols. Additionally, at least one DRIVE Steering Committee member will work with the study investigators as a liaison to support the investigators.
• IPD Sharing Time Frame: Estimated to start in January 2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No