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Delivery Room Intervention and Evaluation Network

NCT ID: NCT06803498

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2042-01-01

Brief Summary

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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

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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.

Conditions

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Resuscitation Infant, Newborn

Keywords

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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DRIVE Network Cohort

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

Receipt of significant resuscitation intervention at birth

Intervention Type PROCEDURE

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

Interventions

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Receipt of significant resuscitation intervention at birth

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Not live born
Minimum Eligible Age

0 Days

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

American Academy of Pediatrics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Foglia, MD MSCE MA FAAP

Role: PRINCIPAL_INVESTIGATOR

Perelman School of Medicine at the University of Pennsylvania

Beena Kamath-Rayne, MD MPH FAAP

Role: PRINCIPAL_INVESTIGATOR

American Academy of Pediatrics

Locations

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American Academy of Pediatrics

Itasca, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Beth Goins

Role: CONTACT

Phone: 630-626-6289

Email: [email protected]

Jessica Weglarz, MBA

Role: CONTACT

Phone: 630-626-6037

Email: [email protected]

Facility Contacts

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Beth Goins

Role: primary

Other Identifiers

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21 FO 01

Identifier Type: -

Identifier Source: org_study_id