Status:
COMPLETED
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
National Eye Institute (NEI)
Conditions:
Infant, Newborn
Infant, Low Birth Weight
Eligibility:
All Genders
Up to 48 years
Phase:
PHASE2
PHASE3
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 progre...
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 pre...
Eligibility Criteria
Inclusion
- 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
- No fatal congenital anomaly or congenital eye anomaly
Key Trial Info
Start Date :
February 1 1994
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 1999
Estimated Enrollment :
649 Patients enrolled
Trial Details
Trial ID
NCT01203436
Start Date
February 1 1994
End Date
March 1 1999
Last Update
June 8 2015
Active Locations (9)
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1
Stanford University
Palo Alto, California, United States, 94304
2
Yale University
New Haven, Connecticut, United States, 06504
3
Emory University
Atlanta, Georgia, United States, 30303
4
Indiana University
Indianapolis, Indiana, United States, 46202