Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01954082 · ClinicalTrials.gov registry record · Phase 3
Inositol to Reduce Retinopathy of Prematurity
A Phase 3 study, sponsored by NICHD Neonatal Research Network.
- Terminated
- Registry status
- Phase 3
- Development phase
- 638
- Enrollment target
NCT01954082: Clinical Trial Phase 3 study, sponsored by NICHD Neonatal Research Network.
NCT01954082 is a Phase 3 study that was terminated before completion, run by NICHD Neonatal Research Network. The registered enrollment target is 638 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01954082, a Phase 3 study, was terminated before completion, sponsored by NICHD Neonatal Research Network.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 638 participants
- Enrollment target
Study Summary
This is a Phase 3, randomized, double-masked, placebo-controlled study designed to determine the effectiveness of myo-Inositol 5% Injection to increase the incidence of survival without severe Retinopathy of Prematurity (ROP) through acute/final ROP determination up to 55 weeks postmenstrual age (PMA) in premature infants \<28 0/7 weeks' gestation.
Primary Outcome
Death is defined as from any cause before Acute/Final ROP status is determined. ROP was identified by routine ophthalmologic examinations beginning at the latter of 31 weeks PMA or 4-6 weeks chronologic age. The favorable ROP endpoint requires that no ROP, or only mild ROP has occurred in both eyes and the eyes have matured beyond the risk of developing Type 1 ROP (severity meeting criteria for surgical intervention). The unfavorable ROP endpoint requires that one or both eyes reach Type 1 ROP.
Interventions
- DRUG Placebo
- DRUG myo-Inositol 5% Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 638 participants |
| Start Date | 2014-04-17 |
| Est. Completion | 2016-12-31 |
| Phase | Phase 3 |
Why NCT01954082 stopped before completion
NCT01954082 is an interventional study that assigns participants to a tested intervention. The registered 638 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01954082 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01954082 about?
NCT01954082 is a clinical study titled "Inositol to Reduce Retinopathy of Prematurity". This is a Phase 3, randomized, double-masked, placebo-controlled study designed to determine the effectiveness of myo-Inositol 5% Injection to increase the incidence of survival without severe Retinopathy of Prematurity (ROP) through acute/final ROP determination up to 55 weeks postmenstrual age (PM...
What is the current status of trial NCT01954082?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 638 participants. The study started on 2014-04-17. Estimated completion is 2016-12-31.
What interventions are being tested in trial NCT01954082?
The interventions under investigation include: Placebo (DRUG), myo-Inositol 5% Injection (DRUG).
Who is sponsoring clinical trial NCT01954082?
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 NCT01954082's enrollment target sits among peer trials
638 579th of 2000 higher than 1,422 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04339699 · 640 participants · NA
NobleStitch EL STITCH Trial is a PFO Comparative Trial
- NCT04979338 · 640 participants · Phase 3
Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
- NCT05156398 · 640 participants · Phase 3
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
- NCT05930483 · 640 participants · NA
Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI