Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

Sponsors

Lead sponsor: NICHD Neonatal Research Network

Collaborator: National 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

Source 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.

Overall Status Completed
Start Date February 1994
Completion Date March 1999
Primary Completion Date March 1999
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery 3 months of age
Enrollment 649
Condition
Intervention

Intervention type: Procedure

Intervention name: Supplemental Oxygen Management

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

Arm group label: Supplemental Oxygen

Intervention type: Procedure

Intervention name: Conventional Oxygen Management

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

Arm group label: Conventional Oxygen

Eligibility

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: 48 Hours

Healthy volunteers: No

Overall Official
Location
facility
Stanford University | Palo Alto, California, 94304, United States
Yale University | New Haven, Connecticut, 06504, United States
Emory University | Atlanta, Georgia, 30303, United States
Indiana University | Indianapolis, Indiana, 46202, United States
Wayne State University | Detroit, Michigan, 48201, United States
Cincinnati Children's Medical Center | Cincinnati, Ohio, 45267, United States
Brown University, Women & Infants Hospital of Rhode Island | Providence, Rhode Island, 02905, United States
University of Tennessee | Memphis, Tennessee, 38163, United States
University of Texas Southwestern Medical Center at Dallas | Dallas, Texas, 75235, United States
Location Countries

United States

Verification Date

June 2015

Responsible Party

Name title: Dale L. Phelps/ Lead Principal Investigator

Organization: University of Rochester

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Supplemental Oxygen

Arm group type: Experimental

Description: Supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%.

Arm group label: Conventional Oxygen

Arm group type: Active Comparator

Description: Conventional oxygenation at a pulse oximetry target of 89% to 94%.

Acronym STOP-ROP
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov