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Completed

NCT Number: NCT01203436

Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supplemental Oxygen Management

Procedure

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

Procedure

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

Primary outcomes

  1. Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery

    Time frame: 3 months of age

    Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Collaborators

  • 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

Registry information

Acronym: STOP-ROP

Important dates

Study start
1994
Primary completion
1999
Study completion
1999
First posted
Sep 16, 2010
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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