Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

Phase 2

Completed

• Conditions: Infant, Newborn; Blindness; Infant, Small for Gestational Age; Retinopathy of Prematurity; Infant, Low Birth Weight; Infant, Premature
• Interventions: Procedure: Conventional Oxygen Management; Procedure: Supplemental Oxygen Management

• Registration Number: NCT01203436
• Lead Sponsor: NICHD Neonatal Research Network

Brief 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.

Detailed Description

Retinopathy of prematurity (ROP) is an abnormal growth of the blood vessels in the eye that occurs primarily in very premature infants. Eye development occurs normally in the womb; in infants born prematurely, however, the blood vessels must finish developing outside the protective environment of the uterus. Retinopathy of prematurity (also known as retrolental fibroplasia) is a leading cause of blindness and other vision impairments (myopia, strabismus, and amblyopia) in children, both in developed and developing countries.

This study was a randomized trial comparing the effects of 2 oxygenation strategies on the progression of ROP. Infants with prethreshold ROP in at least one eye were eligible for the study. Enrolled infants were randomized to receive either conventional oxygenation at a pulse oximetry target of 89% to 94%, or supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%. Infant were placed on continuous pulse oximetry monitoring and to maintain oxygen saturation, as much as possible, in the assigned target range.

Study Timeline

• Study Start: 1994-02
• Primary Completion: 1999-03
• Study Completion: 1999-03
• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 649

Inclusion Criteria

• Infants with prethreshold retinopathy of prematurity, confirmed by 2 certified ophthalmologic exams
• Median pulse oxygen saturation <94% in room air
• Median pulse oxygen saturation can be kept safely >96% on oxygen/ventilator

Exclusion Criteria

• No fatal congenital anomaly or congenital eye anomaly

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Oxygen	Conventional Oxygen Management	Conventional oxygenation at a pulse oximetry target of 89% to 94%.
Supplemental Oxygen	Supplemental Oxygen Management	Supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%.

Primary Outcome Measures

Name	Time	Method
Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery	3 months of age	Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery

Trial Locations

Locations (9)

Stanford University; 🇺🇸 Palo Alto, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Cincinnati Children's Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Brown University, Women & Infants Hospital of Rhode Island; 🇺🇸 Providence, Rhode Island, United States

University of Tennessee; 🇺🇸 Memphis, Tennessee, United States

University of Texas Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States