Clinical trial NCT01203436: Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
Official title: Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
Retinopathy of Prematurity
Blindness
Keywords: NICHD Neonatal Research Network
Very Low Birth Weight (VLBW)
Extremely Low Birth Weight (ELBW)
Prematurity
Lead sponsor: NICHD Neonatal Research Network
Sponsor class: NETWORK
Collaborators: name: National Center for Research Resources (NCRR)
name: National Eye Institute (NEI)
name: National Institute of Nursing Research (NINR)
name: Delta Gamma Sorority
name: Rhea and Raymond White
name: Research to Prevent Blindness
First posted: 2010-09-16
Enrollment: 649
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression from moderate to severe ROP (prethreshold) to threshold ROP requiring peripheral ablative surgery
timeFrame: 3 months of age
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Providence
country: United States
facility: Brown University, Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: University of Rochester
name: Dale L. Phelps, MD
role: STUDY_DIRECTOR
affiliation: The Emmes Company, LLC
name: Neal L. Oden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts Medical Center
name: Cynthia Cole, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Richard E. McClead, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Alan R. Spitzer, MD
role: STUDY_DIRECTOR
affiliation: Arkansas Childrens Hospital
name: J. David Bradford, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Louisville
name: Charles C. Barr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University, Womens and Infants Hospital
name: William Oh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Barbara J. Stoll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: James A. Lemons, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: David K. Stevenson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Edward F. Donovan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee at Memphis
name: Sheldon B. Korones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Jon E. Tyson, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Seetha Shankaran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Richard A. Ehrenkranz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kapiolani Medical Center
name: David Easa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Magee-Womena Hospital
name: Beverly S. Brozanski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane University
name: Robert Gordon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SUNY Stonybrook
name: Pamela A. Weber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Akron Childrens Hospital
name: Frank W. Kokomoor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Michael J. Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Legacy Emanual Childrens Hospital
name: Raul C. Banagale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheridan Childrens Healthcare Services
name: Mitchell E. Stern, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Mark W. Preslan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Shephen S. Feman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: James Kirk, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Fairview University Medical Center
name: Terri L. Young, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Childrens Hospital of Oklahoma
name: Mary Anne McCaffree, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Childrens Medical Center of Northwest Ohio
name: Malini Satish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cook Institute for Research and Education
name: Patrick J. Droste, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes. Pediatrics. 2000 Feb;105(2):295-310. doi: 10.1542/peds.105.2.295.