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NCT00114543 · ClinicalTrials.gov registry record · Phase 3
Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight
A Phase 3 study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,974
- Enrollment target
NCT00114543: Completed Phase 3 study, sponsored by NICHD Neonatal Research Network.
NCT00114543 is a Phase 3 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 1,974 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (156% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00114543, a Phase 3 study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,974 participants
- Enrollment target
Study Summary
This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants. The primary hypothesis was that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age in infants treated by either aggressive or conservative threshold limits. 1,978 infants were enrolled.
Interventions
- PROCEDURE Aggressive Phototherapy 501-750g
- PROCEDURE Aggressive Phototherapy 751-1000g
- PROCEDURE Conservative Phototherapy 501-750g
- PROCEDURE Conservative Phototherapy 751-1000g
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,974 participants |
| Start Date | 2002-09 |
| Est. Completion | 2007-11 |
| Phase | Phase 3 |
What the finished NCT00114543 record still lists
NCT00114543 is an interventional study that assigns participants to a tested intervention. Its 1,974 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (156% higher).
The record links to 0 conditions, and to 4 interventions - of which Aggressive Phototherapy 501-750g is the first listed.
NCT00114543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00114543 about?
NCT00114543 is a clinical study titled "Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight". This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants. The primary hypothesis was that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age in inf...
What is the current status of trial NCT00114543?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,974 participants. The study started on 2002-09. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00114543?
The interventions under investigation include: Aggressive Phototherapy 501-750g (PROCEDURE), Aggressive Phototherapy 751-1000g (PROCEDURE), Conservative Phototherapy 501-750g (PROCEDURE), Conservative Phototherapy 751-1000g (PROCEDURE).
Who is sponsoring clinical trial NCT00114543?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00114543's enrollment target sits among peer trials
1,974 107th of 2000 higher than 1,894 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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