Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial)

This study is ongoing, but not recruiting participants.

First Received: September 23, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	National Eye Institute (NEI)
Information provided by:	National Eye Institute (NEI)
ClinicalTrials.gov Identifier:	NCT00000141

Purpose

To test the efficacy, safety, and costs of providing supplemental oxygen in moderately severe retinopathy of prematurity (prethreshold ROP).

Condition	Intervention	Phase
Retinopathy of Prematurity	Drug: Oxygen	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized

Resource links provided by NLM:

MedlinePlus related topics: Retinal Disorders

U.S. FDA Resources

Further study details as provided by National Eye Institute (NEI):

Study Start Date:

May 1997

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 1 Year
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Newborns with prethreshold ROP in one or both eyes are eligible.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000141

Show 24 Study Locations

Sponsors and Collaborators

National Eye Institute (NEI)

More Information

Publications:

Phelps DL; Palmer EA; Wood NE; Supplemental oxygen for prethreshold retinopathy of prematurity (a description of the study background and design), in Shapiro MJ, Biglan AW, Miller MT (eds)., Proceedings of the International Conference on Retinopathy of Prematurity, Amsterdam, Kugler Publications 1995:139-141

[No authors listed] Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes. Pediatrics. 2000 Feb;105(2):295-310.

Study ID Numbers:	NEI-40
Study First Received:	September 23, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000141 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Eye Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases
Retinopathy of Prematurity
Retinal Diseases

Additional relevant MeSH terms:

Eye Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases
Retinopathy of Prematurity
Retinal Diseases

ClinicalTrials.gov processed this record on July 02, 2009