Delivery Room Intervention and Evaluation Network

Recruiting

• Conditions: Resuscitation; Infant, Newborn

• Registration Number: NCT06803498
• Lead Sponsor: American Academy of Pediatrics

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.

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 Timeline

• Study Start: 2022-01-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Primary Completion: 2042-01-01
• Study Completion: 2042-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000000

Inclusion Criteria

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

Exclusion Criteria

Not live born

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient disposition	Immediately after the resuscitation intervention	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

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	Within 30 days after birth	Whether the patient died following resuscitation

Trial Locations

Locations (1)

American Academy of Pediatrics; 🇺🇸 Itasca, Illinois, United States