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NCT01203436 · ClinicalTrials.gov registry record · Phase 2
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
A Phase 2 study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 649
- Enrollment target
NCT01203436: Completed Phase 2 study, sponsored by NICHD Neonatal Research Network.
NCT01203436 is a Phase 2 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 649 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (388% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01203436, a Phase 2 study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 649 participants
- Enrollment target
Study Summary
The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and the need for peripheral retinal ablation.
Primary Outcome
Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery
Interventions
- PROCEDURE Supplemental Oxygen Management
- PROCEDURE Conventional Oxygen Management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 649 participants |
| Start Date | 1994-02 |
| Est. Completion | 1999-03 |
| Phase | Phase 2 |
What the finished NCT01203436 record still lists
NCT01203436 is an interventional study that assigns participants to a tested intervention. The registered 649 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (388% higher).
The record links to 0 conditions, and to 2 interventions - of which Supplemental Oxygen Management is the first listed.
NCT01203436 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01203436 about?
NCT01203436 is a clinical study titled "Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity". The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and the need for peripheral retinal ablation.
What is the current status of trial NCT01203436?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 649 participants. The study started on 1994-02. Estimated completion is 1999-03.
What interventions are being tested in trial NCT01203436?
The interventions under investigation include: Supplemental Oxygen Management (PROCEDURE), Conventional Oxygen Management (PROCEDURE).
Who is sponsoring clinical trial NCT01203436?
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 NCT01203436's enrollment target sits among peer trials
649 50th of 2000 higher than 1,951 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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