Light Reduction for Retinopathy of Prematurity Prevention in Low Birth-Weight Infants
Data Collection
Eye Diseases+3
+ Infant, Newborn, Diseases
+ Infant, Premature, Diseases
Treatment Study
Summary
Study start date: July 1, 1995
Actual date on which the first participant was enrolled.Retinopathy of Prematurity (ROP) is a condition that can lead to blindness in about 2.1% of extremely low birth-weight infants (those weighing less than 1,251 grams). Current treatments, like cryotherapy, are not always effective and can sometimes cause other vision problems. As medical care improves and more premature infants survive, the number of infants at risk for blindness from ROP is expected to increase. This study aims to find a safe, effective, easy-to-use, and affordable preventive treatment for ROP. The researchers believe that reducing the amount of light that reaches the eyes of premature infants might help prevent ROP, as light can produce harmful substances called free radicals that can damage the eyes. In this study, infants weighing less than 1,251 grams at birth are randomly assigned within 24 hours of birth to either wear goggles or not. These goggles block 97% of light and are worn until the infant reaches either 31 weeks gestational age or 4 weeks postnatal age, whichever is longer. All infants, whether they wear goggles or not, are exposed to the same amount of ambient light. The eyes of all infants are examined on a regular schedule to check for ROP. The main goal of this study is to determine if light reduction decreases the occurrence of any confirmed ROP. The study involves around 400 infants, equally divided into goggle-wearing and control groups, and is currently in the follow-up phase with regular eye exams until either ROP regression or normal full retinal vascularization is established.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
The Children's Hospital of Buffalo
Buffalo, United StatesOpen The Children's Hospital of Buffalo in Google MapsThe University of Texas, Southwestern Medical Center at Dallas
Dallas, United StatesUniversity of Texas, Health Science Center, San Antonio
San Antonio, United States