Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP)

NICHD Neonatal Research Network

Status and phase: Completed; Phase 3; Phase 2

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

Treatments: Procedure: Conventional Oxygen Management; Procedure: Supplemental Oxygen Management

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT01203436

U10HD021415 (U.S. NIH Grant/Contract)

NICHD-NRN-0010

U10HD027853 (U.S. NIH Grant/Contract)

M01RR000070 (U.S. NIH Grant/Contract)

U10HD027880 (U.S. NIH Grant/Contract)

U10HD027856 (U.S. NIH Grant/Contract)

U10HD027851 (U.S. NIH Grant/Contract)

U10HD040689 (U.S. NIH Grant/Contract)

M01RR000054 (U.S. NIH Grant/Contract)

U10HD021385 (U.S. NIH Grant/Contract)

U10HD027904 (U.S. NIH Grant/Contract)

U10HD027871 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 649 patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

649 participants in 2 patient groups

Supplemental Oxygen

Experimental group

Description:

Supplemental oxygen to achieve a pulse oximetry target range of 96% to 99%.

Treatment:

Procedure: Supplemental Oxygen Management

Conventional Oxygen

Active Comparator group

Description:

Conventional oxygenation at a pulse oximetry target of 89% to 94%.

Treatment:

Procedure: Conventional Oxygen Management