Blindness, Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age, Retinopathy of Prematurity
Conditions
Keywords
NICHD Neonatal Research Network, Very Low Birth Weight (VLBW), Extremely Low Birth Weight (ELBW), Prematurity
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESupplemental Oxygen Management
Supplemental arm with pulse oximetry targeted at 96% to 99% saturation, for at least 2 weeks, and until both eyes were at study endpoints.
PROCEDUREConventional Oxygen Management
Conventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation.
Sponsors
National Center for Research Resources (NCRR)
National Eye Institute (NEI)
National Institute of Nursing Research (NINR)
Delta Gamma Sorority
Rhea and Raymond White
Research to Prevent Blindness
NICHD Neonatal Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 48 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery | 3 months of age | Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery |
Countries
United States
Outcome results
None listed