Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

Retinopathy of Prematurity Clinical Trial

— STOP-ROP  

Official title:

Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203436
• Other study ID #: NICHD-NRN-0010
• Secondary ID: U10HD027904U10HD
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 15, 2010
• Last updated: June 3, 2015
• Start date: February 1994
• Est. completion date: March 1999

Study information

• Verified date: June 2015
• Source: NICHD Neonatal Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00000141

Recruitment information / eligibility

• Status: Completed
• Enrollment: 649
• Est. completion date: March 1999
• Est. primary completion date: March 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 48 Hours

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Blindness
• Infant, Low Birth Weight
• Infant, Newborn
• Infant, Premature
• Infant, Small for Gestational Age
• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Procedure:
• Supplemental Oxygen Management
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 Management
Conventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Wayne State University	Detroit	Michigan
United States	Indiana University	Indianapolis	Indiana
United States	University of Tennessee	Memphis	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Stanford University	Palo Alto	California
United States	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island

Sponsors (7)

Lead Sponsor	Collaborator
NICHD Neonatal Research Network	Delta Gamma Sorority, National Center for Research Resources (NCRR), National Eye Institute (NEI), National Institute of Nursing Research (NINR), Research to Prevent Blindness, Rhea and Raymond White

Country where clinical trial is conducted

United States, 

References & Publications (1)

Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes. Pediatrics. 2000 Feb;105(2):295-310. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery	Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery	3 months of age	Yes

External Links

•   NICHD Neonatal Research Network