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 is a Phase 3 study that was terminated before completion, run by NICHD Neonatal Research Network. The registered enrollment target is 638 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Interventions

  • DRUG Placebo
  • DRUG myo-Inositol 5% Injection

Trial Details

FieldValue
Enrollment Target 638 participants
Start Date 2014-04-17
Est. Completion 2016-12-31
Phase Phase 3

Sponsor

NICHD Neonatal Research Network

61 total trials

What the Registry Record Tells You About NCT01954082

The ClinicalTrials.gov registry entry for NCT01954082 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 638 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 2 interventions - of which Placebo is the first listed.

NCT01954082 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.