Light Reduction for Retinopathy of Prematurity Prevention in Low Birth-Weight Infants
Collecte de données
Maladies oculaires+3
+ Maladies du nouveau-né
+ Maladies du prématuré
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 1995
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Conditions
Pathologie
Critères
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.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 3 sites
The Children's Hospital of Buffalo
Buffalo, United StatesOuvrir The Children's Hospital of Buffalo dans Google MapsThe University of Texas, Southwestern Medical Center at Dallas
Dallas, United StatesUniversity of Texas, Health Science Center, San Antonio
San Antonio, United States