Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity

Conditions
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Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Retinopathy of Prematurity, Blindness

Intervention / Treatment
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* Procedure: Supplemental Oxygen Management
* Procedure: Conventional Oxygen Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplemental Oxygen<br>Supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%. | Procedure: Supplemental Oxygen Management<br>* Supplemental arm with pulse oximetry targeted at 96% to 99% saturation, for at least 2 weeks, and until both eyes were at study endpoints.<br>|
| Active Comparator: Conventional Oxygen<br>Conventional oxygenation at a pulse oximetry target of 89% to 94%. | Procedure: Conventional Oxygen Management<br>* Conventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery | Progressing from moderate ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery | 3 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NICHD Neonatal Research Network, Very Low Birth Weight (VLBW), Extremely Low Birth Weight (ELBW), Prematurity