CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 649 enrolled
Drug / intervention
Supplemental Oxygen Management +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01203436
NCT01203436Phase 3Completed
CompareCT.gov

Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

NICHD Neonatal Research Network·interventional·Posted Sep 16, 2010·Updated Jun 8, 2015

In Brief

A Phase 3 clinical trial evaluating Supplemental Oxygen Management and Conventional Oxygen Management for Infant, Newborn and 5 related conditions. Completed, enrolled 649 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Retinopathy of Prematurity, Blindness
CountriesUnited States
CollaboratorsNational Center for Research Resources (NCRR), National Eye Institute (NEI), National Institute of Nursing Research (NINR), Delta Gamma Sorority, Rhea and Raymond White, Research to Prevent Blindness

Timeline

Phase 3CompletedFinished
1994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2010
Enrollment StartFeb 1, 1994
Primary CompletionMar 1, 1999
TodayJul 1, 2026
Enrollment to primary: 5.1 yearsPosted 15.8 years ago

Interventions

Supplemental Oxygen Managementprocedure

Supplemental arm with pulse oximetry targeted at 96% to 99% saturation, for at least 2 weeks, and until both eyes were at study endpoints.

Conventional Oxygen Managementprocedure

Conventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation.