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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 is a Phase 3 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 1,974 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00114543
The ClinicalTrials.gov registry entry for NCT00114543 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,974 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Aggressive Phototherapy 501-750g is the first listed.
NCT00114543 reports 0 study locations.
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.
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