NCT00000156

Brief Summary

To evaluate the effect of ambient light reduction on the incidence of retinopathy of prematurity (ROP).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1995

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
Last Updated

June 5, 2006

Status Verified

October 1, 2003

First QC Date

September 23, 1999

Last Update Submit

June 2, 2006

Conditions

Retinopathy of Prematurity

Interventions

GogglesDEVICE
Ambient Light ReductionPROCEDURE

Eligibility Criteria

AgeUp to 1 Day
Sexall
Age GroupsChild (0-17)
Premature infants weighing less than 1,251 grams at birth and having a gestational age of less than 31 weeks were eligible for randomization. Consent must have been obtained within 24 hours of birth. Patients with major congenital anomalies are excluded.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

The Children's Hospital of Buffalo

Buffalo, New York, United States

Location

The University of Texas, Southwestern Medical Center at Dallas

Dallas, Texas, United States

Location

University of Texas, Health Science Center, San Antonio

San Antonio, Texas, United States

Location

Related Publications (1)

  • Reynolds JD, Hardy RJ, Kennedy KA, Spencer R, van Heuven WA, Fielder AR. Lack of efficacy of light reduction in preventing retinopathy of prematurity. Light Reduction in Retinopathy of Prematurity (LIGHT-ROP) Cooperative Group. N Engl J Med. 1998 May 28;338(22):1572-6. doi: 10.1056/NEJM199805283382202.

    PMID: 9603794BACKGROUND

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Eye Protective Devices

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Personal Protective EquipmentProtective DevicesEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

July 1, 1995

Last Updated

June 5, 2006

Record last verified: 2003-10

Locations

US(3)