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NCT01223287 · ClinicalTrials.gov registry record
Physiologic Definition of Bronchopulmonary Dysplasia
A clinical trial of Infant, Premature and Infant, Newborn, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- 410
- Enrollment target
- 20
- Study locations
NCT01223287: Completed study of Infant, Premature and Infant, Newborn, sponsored by NICHD Neonatal Research Network.
NCT01223287 is a study of Infant, Premature and Infant, Newborn that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 410 participants, below the 9,861-participant average among 16 other Infant, Premature trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01223287, a study of Infant, Premature and Infant, Newborn, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- 410 participants
- Enrollment target
- 20
- Study locations
Study Summary
This observational study was conducted to design and test a physiologic definition for bronchopulmonary dysplasia at 36 weeks of life. Infants were studied in a supine position with the pulse oximeter in position with good signal prior to collecting baseline data. Feedings and medications were given 30 minutes before the evaluation. Baseline data was collected on infant's current oxygen. Then, the infants were weaned to room air for 30 minutes. If saturations remain ≥90%, the infant was considered to have passed the oxygen reduction challenge (to NOT have BPD). The infant should then be placed back in his/her baseline oxygen. If the infant has saturations \<90% for 5 continuous minutes or \<80% for 15 seconds, the infant should be immediately placed back in his/her baseline oxygen, and the infant was considered to have NOT passed the challenge (to have BPD).
Conditions Studied
Study Locations (20)
North Carolina
- Wake Forest University - Charlotte
- RTI International - Durham
- Duke University - Durham
California
- Stanford University - Palo Alto
- University of California at San Diego - San Diego
Ohio
- Cincinnati Children's Medical Center - Cincinnati
- Case Western Reserve University, Rainbow Babies and Children's Hospital - Cleveland
Texas
- University of Texas Southwestern Medical Center at Dallas - Dallas
- University of Texas Health Science Center at Houston - Houston
Alabama
- University of Alabama - Birmingham
Connecticut
- Yale University - New Haven
Florida
- University of Miami - Miami
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 410 participants |
| Start Date | 2005-05 |
| Est. Completion | 2008-09 |
What the finished NCT01223287 record still lists
NCT01223287 is an observational study that tracks outcomes without assigning an intervention. The registered 410 participants enrollment target is mid-sized for trials with a published cap, below the 9,861-participant average among 16 other Infant, Premature trials with a reported enrollment target (96% lower).
The record links to 5 conditions, with Infant, Premature appearing as the primary indexed condition, and to 0 interventions.
NCT01223287 names 20 study sites across 15 states, led by North Carolina, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT01223287 about?
NCT01223287 is a clinical study titled "Physiologic Definition of Bronchopulmonary Dysplasia". This observational study was conducted to design and test a physiologic definition for bronchopulmonary dysplasia at 36 weeks of life. Infants were studied in a supine position with the pulse oximeter in position with good signal prior to collecting baseline data. Feedings and medications were given...
What is the current status of trial NCT01223287?
This trial is currently completed. The enrollment target is 410 participants. The study started on 2005-05. Estimated completion is 2008-09.
What conditions does trial NCT01223287 study?
This clinical trial studies the following conditions: Infant, Premature, Infant, Newborn, Infant, Small for Gestational Age, Infant, Low Birth Weight, Bronchopulmonary Dysplasia (BPD).
Who is sponsoring clinical trial NCT01223287?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01223287 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01223287's enrollment target sits among peer trials
410 10th of 16 higher than 7 of 16 other Infant, Premature trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infant, Premature 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.
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