ResuscitationDRIVE NetworkNCT06803498
Delivery Room Intervention and Evaluation Network
An observational study of Resuscitation and Infant, Newborn, run by American Academy of Pediatrics at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Resuscitation, Infant, Newborn
- What is being tested?
- Receipt of significant resuscitation intervention at birth
- Type of treatment
- Surgery or procedure
- How many people
- 3,000,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 1 Jan 2042
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Inborn infant in receipt of a significant resuscitation intervention (CPAP, PPV, intubation, or CPR) at birth
Who cannot join
- Not live born
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
American Academy of Pediatrics
Itasca, Illinois, 60143
Beth Goins, (630) 626-6289, bgoins@aap.org
Beena Kamath-Rayne, MD MPH FAAP
About this study
Official title: 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.
Read the 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.
- Conditions
- Resuscitation, Infant, Newborn
- Being tested
- Receipt of significant resuscitation intervention at birth
- Keywords
- Continuous Positive Airway Pressure, Intermittent Positive Pressure Ventilation, Intubation, Intratracheal, Cardiopulmonary Resuscitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receipt of significant resuscitation intervention at birthProcedure or surgery
Receipt of CPAP, PPV, intubation, or CPR at birth in a hospital delivery room
| Study group | Role | What they receive |
|---|---|---|
| DRIVE Network Cohort | All infants who receive significant resuscitation intervention (CPAP, PPV, intubation, or CPR) at birth in a DRIVE Network member hospital. Receives: Procedure: Receipt of significant resuscitation intervention at birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after the resuscitation intervention
Secondary outcomes (1)
In-hospital mortality
Whether the patient died following resuscitation
Measured: Within 30 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Jan 2022
- Primary completion1 Jan 2042 (estimated)
- Study completion1 Jan 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Academy of Pediatrics
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Elizabeth Foglia, MD MSCE MA FAAP, Principal investigator, Perelman School of Medicine at the University of PennsylvaniaBeena Kamath-Rayne, MD MPH FAAP, Principal investigator, American Academy of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803498
- Sponsor's protocol ID
- 21 FO 01
- Acronym
- DRIVE Network
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery Room Intervention and Evaluation (DRIVE) Network
- ClinicalTrials.gov ID
- NCT06803498
- Acronym / sponsor ID
- DRIVE Network / 21 FO 01
- Conditions
- Resuscitation, Infant, Newborn
- Keywords
- Continuous Positive Airway Pressure, Intermittent Positive Pressure Ventilation, Intubation, Intratracheal, Cardiopulmonary Resuscitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000,000 participants (estimated)
- Lead sponsor
- American Academy of PediatricsUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2042 (estimated)
- Study completion
- 1 Jan 2042 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DRIVE Network Cohort | – | Procedure: Receipt of significant resuscitation intervention at birthAll infants who receive significant resuscitation intervention (CPAP, PPV, intubation, or CPR) at birth in a DRIVE Network member hospital. |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Inborn infant in receipt of a significant resuscitation intervention (CPAP, PPV, intubation, or CPR) at birth
Key exclusion criteria (1 listed)
- Not live born
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receipt of significant resuscitation intervention at birthReceipt of CPAP, PPV, intubation, or CPR at birth in a hospital delivery room | Procedure or surgery | DRIVE Network Cohort |
Primary outcome
Patient disposition
Time frame: 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
1 secondary outcome
In-hospital mortality
Time frame: Within 30 days after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Foglia, MD MSCE MA FAAP principal investigator
Perelman School of Medicine at the University of Pennsylvania
Beena Kamath-Rayne, MD MPH FAAP principal investigator
American Academy of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resuscitation and Infant, Newborn, run by American Academy of Pediatrics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beth Goins (630-626-6289, bgoins@aap.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient disposition (time frame: Immediately after the resuscitation intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.