Clinical trial NCT06803498: Delivery Room Intervention and Evaluation Network
Official title: Delivery Room Intervention and Evaluation (DRIVE) Network
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Resuscitation
Infant, Newborn
Keywords: Continuous Positive Airway Pressure
Intermittent Positive Pressure Ventilation
Intubation, Intratracheal
Cardiopulmonary Resuscitation
Lead sponsor: American Academy of Pediatrics
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2025-01-31
Enrollment: 3000000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Not live born

Primary outcomes:
measure: Patient disposition
timeFrame: Immediately after the resuscitation intervention
Secondary outcomes:
measure: In-hospital mortality
timeFrame: Within 30 days after birth
Other outcomes:
Locations:
city: Itasca
country: United States
facility: American Academy of Pediatrics
state: Illinois
Study officials:
affiliation: Perelman School of Medicine at the University of Pennsylvania
name: Elizabeth Foglia, MD MSCE MA FAAP
role: PRINCIPAL_INVESTIGATOR
affiliation: American Academy of Pediatrics
name: Beena Kamath-Rayne, MD MPH FAAP
role: PRINCIPAL_INVESTIGATOR
References: