CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 410 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01223287
NCT01223287N/ACompleted

Physiologic Definition of Bronchopulmonary Dysplasia

NICHD Neonatal Research Network·observational·Posted Oct 18, 2010·Updated Sep 26, 2017

In Brief

An observational study for Infant, Newborn and 4 related conditions. Completed, enrolled 410 participants across 21 sites.

Detailed 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).

Study Details

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2010
Enrollment StartMay 1, 2005
Primary CompletionMay 1, 2008
Study CompletionSep 1, 2008
TodayJul 1, 2026
Enrollment to primary: 3 yearsPosted 15.7 years ago