Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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).

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

Sponsor

NICHD Neonatal Research Network

61 total trials

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.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.