Infant, NewbornPhase 1/2DR-CPAPNCT01223274
Delivery Room CPAP in Extremely Low Birth Weight Infants
A Phase 1/2 study testing CPAP/PEEP and Standard management practices in people with Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 6 sites in United States.
Trial summary
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation… Read more about this study
- Who is it for?
- Ages Up to 10 minutes
- Conditions the study is for
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age
- What is being tested?
- CPAP/PEEP and Standard management practices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2002to Jan 2003
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 Up to 10 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants delivered in a specially equipped resuscitation room(s)
- <28 weeks gestational age by best obstetric estimate before delivery
- Requiring resuscitation
Who cannot join
- No known major congenital anomalies
- Decision made not to provide full resuscitation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
RTI International
Durham, North Carolina, 27705
University of Miami
Miami, Florida, 33136
University of California at San Diego
San Diego, California, 92103-8774
About this study
Official title: Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).
Read the detailed description
Previous studies suggested that early continuous airway positive pressure (CPAP) may be beneficial in reducing ventilator dependence and subsequent bronchopulmonary dysplasia (BPD) in extremely low birth weight (ELBW) infants. These studies did not test for the optimal timing of CPAP initiation or compare CPAP/PEEP initiation in the delivery room against standard resuscitation methods. Current practice at the time was for the ELBW infant to be intubated early and administered prophylactic surfactant. The feasibility of initiating CPAP in the DR and continuing this therapy without intubation for surfactant had not been determined prospectively in a population of ELBW infants.
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia, Continuous Positive Airway Pressure
- Being tested
- CPAP/PEEP, Standard management practices
- Keywords
- NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity, Mechanical ventilation, Positive-Pressure Ventilation, Surfactant, Intubation, Pulse oximetry, Oxygen saturation
- Medical subject headings
- Premature Birth, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP/PEEPDevice
Also called Neopuff
Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV.
Standard management practicesDevice
Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.
| Study group | Role | What they receive |
|---|---|---|
| CPAP/PEEP Intervention | Experimental | Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV. Receives: Device: CPAP/PEEP |
| Control | Active comparator | Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used. Receives: Device: Standard management practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with the study protocol
Measured: 6 months
Secondary outcomes (7)
Extent of resuscitation needed
Measured: Until admission to NICU
Five minute Apgar
Measured: 5 minutes after birth
Total duration of mechanical ventilation
Measured: Until hospital discharge or 120 days of life
Proportion of infants requiring surfactant
Measured: 1 day of life
Bronchopulmonary dysplasia (BPD)
Measured: 36 weeks of life
Number and duration of intubation attempts
Measured: Until admission to the NICU
Infants who required positive pressure ventilation for resuscitation in the DR/resuscitation room
Measured: Until admission to the NICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startJul 2002
- Primary completionJan 2003
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, NewbornStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Neil N. Finer, MD, Study director, University of California, San DiegoAvroy A. Fanaroff, MD, Principal investigator, Case Western Reserve University, Rainbow Babies & Children's HospitalWaldemar A. Carlo, MD, Principal investigator, University of Alabama at BirminghamEdward F. Donovan, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiCharles R. Bauer, MD, Principal investigator, University of MiamiW. Kenneth Poole, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223274
- Sponsor's protocol ID
- NICHD-NRN-0028
- Other IDs
- U10HD021364, M01RR000080, U10HD034216, U10HD027853, M01RR008084, U10HD021397, M01RR016587, U10HD040461
- Acronym
- DR-CPAP
- Status last verified
- Jun 2026
- First submitted
- 14 Oct 2010
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics. 2004 Sep;114(3):651-7. doi: 10.1542/peds.2004-0394.
PubMed 15342835
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants
- ClinicalTrials.gov ID
- NCT01223274
- Acronym / sponsor ID
- DR-CPAP / NICHD-NRN-0028
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia, Continuous Positive Airway Pressure
- Keywords
- NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Very Low Birth Weight (VLBW), Prematurity, Mechanical ventilation, Positive-Pressure Ventilation, Surfactant, Intubation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2002
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 18 Oct 2010 (estimated)
- 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.
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).
Detailed description
Previous studies suggested that early continuous airway positive pressure (CPAP) may be beneficial in reducing ventilator dependence and subsequent bronchopulmonary dysplasia (BPD) in extremely low birth weight (ELBW) infants. These studies did not test for the optimal timing of CPAP initiation or compare CPAP/PEEP initiation in the delivery room against standard resuscitation methods. Current practice at the time was for the ELBW infant to be intubated early and administered prophylactic surfactant. The feasibility of initiating CPAP in the DR and continuing this therapy without intubation for surfactant had not been determined prospectively in a population of ELBW infants.
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP/PEEP Intervention | Experimental | Device: CPAP/PEEPInfants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV. |
| Control | Active comparator | Device: Standard management practicesControl infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used. |
Who may qualify
- Ages
- Up to 10 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants delivered in a specially equipped resuscitation room(s)
- <28 weeks gestational age by best obstetric estimate before delivery
- Requiring resuscitation
Key exclusion criteria (2 listed)
- No known major congenital anomalies
- Decision made not to provide full resuscitation
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 |
|---|---|---|
| CPAP/PEEPAlso: NeopuffInfants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV. | Device | CPAP/PEEP Intervention |
| Standard management practicesControl infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used. | Device | Control |
Primary outcome
Compliance with the study protocol
Time frame: 6 months
7 secondary outcomes
Extent of resuscitation needed
Time frame: Until admission to NICU
Five minute Apgar
Time frame: 5 minutes after birth
Total duration of mechanical ventilation
Time frame: Until hospital discharge or 120 days of life
Proportion of infants requiring surfactant
Time frame: 1 day of life
Bronchopulmonary dysplasia (BPD)
Time frame: 36 weeks of life
Number and duration of intubation attempts
Time frame: Until admission to the NICU
Infants who required positive pressure ventilation for resuscitation in the DR/resuscitation room
Time frame: Until admission to the NICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Results publication: PubMed 15342835Finer NN, Carlo WA, Duara S, Fanaroff AA, Donovan EF, Wright LL, Kandefer S, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Delivery room continuous positive airway pressure/positive end-expiratory pressure in extremely low birth weight infants: a feasibility trial. Pediatrics. 2004 Sep;114(3):651-7. doi: 10.1542/peds.2004-0394.
- NICHD Neonatal Research NetworkLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Neil N. Finer, MD study director
University of California, San Diego
Avroy A. Fanaroff, MD principal investigator
Case Western Reserve University, Rainbow Babies & Children's Hospital
Waldemar A. Carlo, MD principal investigator
University of Alabama at Birmingham
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CPAP/PEEP and Standard management practices in people with Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 6 sites 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with the study protocol (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01223274, which also lists 1 linked publication.
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 1 Jul 2026.