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NCT01223274 · ClinicalTrials.gov registry record · Phase 1
Delivery Room CPAP in Extremely Low Birth Weight Infants
A Phase 1 study of Bronchopulmonary Dysplasia and Infant, Newborn, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 1
- Development phase
- 104
- Enrollment target
- 6
- Study locations
NCT01223274 is a Phase 1 study of Bronchopulmonary Dysplasia and Infant, Newborn that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 104 participants, below the 233-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (55% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT01223274, a Phase 1 study of Bronchopulmonary Dysplasia and Infant, Newborn, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 104 participants
- Enrollment target
- 6
- Study locations
Study 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 (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 Studied
Interventions
- DEVICE CPAP/PEEP
- DEVICE Standard management practices
Study Locations (6)
Ohio
- Cincinnati Children's Medical Center - Cincinnati
- Case Western Reserve University, Rainbow Babies and Children's Hospital - Cleveland
Alabama
- University of Alabama at Birmingham - Birmingham
California
- University of California at San Diego - San Diego
Florida
- University of Miami - Miami
North Carolina
- RTI International - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2002-07 |
| Est. Completion | 2003-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01223274
The ClinicalTrials.gov registry entry for NCT01223274 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 233-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (55% lower). The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 2 interventions - of which CPAP/PEEP is the first listed.
NCT01223274 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Ohio, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT01223274 about?
NCT01223274 is a clinical study titled "Delivery Room CPAP in Extremely Low Birth Weight 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 pre...
What is the current status of trial NCT01223274?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2002-07. Estimated completion is 2003-01.
What conditions does trial NCT01223274 study?
This clinical trial studies the following conditions: Bronchopulmonary Dysplasia, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age, Infant, Low Birth Weight.
What interventions are being tested in trial NCT01223274?
The interventions under investigation include: CPAP/PEEP (DEVICE), Standard management practices (DEVICE).
Who is sponsoring clinical trial NCT01223274?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01223274 being conducted?
This trial has 6 study locations across Alabama, California, Florida, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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