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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, Premature, sponsored by NICHD Neonatal Research Network.

Completed
Registry status
Phase 1
Development phase
104
Enrollment target
6
Study locations

NCT01223274: Completed Phase 1 study of Bronchopulmonary Dysplasia and Infant, Premature, sponsored by NICHD Neonatal Research Network.

NCT01223274 is a Phase 1 study of Bronchopulmonary Dysplasia and Infant, Premature 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. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01223274, a Phase 1 study of Bronchopulmonary Dysplasia and Infant, Premature, 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

Bronchopulmonary Dysplasia Infant, Premature Infant, Newborn Infant, Small for Gestational Age Infant, Low Birth Weight Continuous Positive Airway Pressure

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

FieldValue
Enrollment Target 104 participants
Start Date 2002-07
Est. Completion 2003-01
Phase Phase 1
NICHD Neonatal Research Network

61 total trials

What the finished NCT01223274 record still lists

NCT01223274 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 233-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (55% lower).

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 lists 6 locations in 5 states (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, Premature, Infant, Newborn, 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.

Learn More About Clinical Trials

Similar trials for Bronchopulmonary Dysplasia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01223274's enrollment target sits among peer trials

104 17th of 29 higher than 13 of 29 other Bronchopulmonary Dysplasia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Bronchopulmonary Dysplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01223274, the US trial registry maintained by the National Library of Medicine. NCT01223274 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.