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Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial) conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial) Clinical research trials and Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial) health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial). Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial) Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial) clinical trial. Participants oftentimes recieve the most expert healthcare available for their Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial) condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial)  Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial)
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial)
For Condition: Retinopathy of Prematurity
Status: No longer recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: To test the efficacy, safety, and costs of providing supplemental oxygen in moderately severe retinopathy of prematurity (prethreshold ROP).
Details: ROP remains one of the important morbidities among extremely premature infant survivors who are otherwise experiencing great gains in survival and in pulmonary and neurologic sequelae. While the use of cryo- or laser ablation of peripheral retina during the severe stages of ROP reduces the proportion of infants who progress to retinal detachments, less destructive treatment would be desirable. More than 80 percent of infants who develop ROP heal the retinal neovascularization spontaneously, while only the minority progress to severe stages. Apparently, the normal physiologic control of retinal vascular growth is usually enough to control ROP. This observation led to basic studies on the control of normal and abnormal retinal vascularization that have identified tissue oxygen levels as important in the control of vessel growth. Combined with the observation of marginally low oxygen levels in the sickest of premature infants during their long convalescence from lung disease, an idea emerged. The hypothesis was that marginally low blood oxygen levels could interfere with control of retinal neovascularization -- the low levels further stimulating the vessel overgrowth. When that proved true in animal studies, the reverse experiment was tested and showed that raising the oxygen slightly over normal was enough to improve the retinopathy in its convalescent stages. Therefore, the STOP-ROP clinical trial was designed to test the hypothesis that supplemental oxygen in moderately severe (prethreshold) ROP would reduce the proportion of eyes that would progress to severe (threshold) levels of ROP. Infants who develop moderately severe ROP are recruited to participate in STOP-ROP. Following informed consent, eligible infants are randomized to oxygen administration with continuous saturation monitoring at conventional levels (target pulse oximetry, 89-94 percent saturation) versus supplemental levels (target pulse oximetry, 96-99 percent saturation). Pulse oximetry is monitored continuously, and feedback to the bedside nurses is provided in a variety of formats on a laptop computer screen. Compliance with study targets is recorded systematically. Exact severity of ROP is confirmed by two independent, masked ophthalmologists at study entry and again if severe ROP (threshold) occurs. Infants remain on study-assigned oxygen saturation ranges for at least 2 weeks and until both eyes have reached study end points. An adverse end point is progression to threshold ROP (with referral for possible ablative therapy). A favorable end point is regression of the ROP into zone 3 for at least two examinations, or complete retinal vascularization. Weekly examinations of the infants by study-certified, masked ophthalmologists ensure timely identification of study end points and limit use of study-assigned treatment and equipment to what is absolutely necessary. The pediatric end points of rate of growth, cardiopulmonary stability, and achievement of early motor milestones are also measured as secondary end points. All infants receive a final followup examination to confirm retinal status and pediatric end points at 3 months following their expected full-term due date (usually 5-6 months following birth). To make it possible to detect a reduction in progression to threshold ROP from 30 percent to 20 percent, 880 infants will be enrolled. The Data and Safety Monitoring Committee monitors primary and secondary outcome measures and all adverse events over the course of the study. Study Organization The STOP-ROP study is uniquely funded and organized to promote research on behalf of vision in children. The NEI fully funds the Study Headquarters, the Data and Safety Monitoring Committee, and seven participating centers. The NEI and the National Institute of Child Health and Human Development (NICHD) support another 10 centers through the NICHD Neonatal Network for Clinical Trials. The National Institute of Nursing Research also contributes to the support of the study. The remaining centers are participating with alternative funds or through volunteer efforts and with a capitation from the NEI provided per patient enrolled.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: /1 Year
Genders: Both
Protocol Entry Criteria: Newborns with prethreshold ROP in one or both eyes are eligible.
Total Enrollment:
Location and Contact Information:
University of Illinois at Chicago, Department of Ophthalmology
Chicago, Illinois, 60612
United States
University Hospital at Stony Brook, Department of Ophthalmology
Stony Brook, New York, 11794-1110
United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
United States
Children's Medical Center of Northwest Ohio, Toledo Hospital, Division of Neonatology
Toledo, Ohio, 43606
United States
University of Maryland Hospital, Department of Ophthalmology N6W46
Baltimore, Maryland, 21201
United States
Legacy Emanuel Children's Hospital, Legacy Research
Portland, Oregon, 97227
United States
E.H. Crump Hospital, Division of Neonatology, Room 201
Memphis, Tennessee, 38163
United States
Sheridan Children's Healthcare Services, Inc., Plantation General Hospital
Plantation, Florida, 33317
United States
Magee-Women's Hospital, Department of Pediatrics
Pittsburgh, Pennsylvania, 15213-3180
United States
Retina Associates, P.A.
Jacksonville, Florida, 32204
United States
University of Rochester School of Medicine, Pediatrics/Neonatology, Room 4-4167
Rochester, New York, 14642
United States
Cook Institute for Research
Grand Rapids, Michigan, 49546
United States
Vanderbilt University Medical Center, Department of Ophthalmology
Nashville, Tennessee, 37232-8808
United States
James Whitcomb Riley Hospital, Indiana University Medical Center
Indianapolis, Indiana, 46202-5210
United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104
United States
Thomas Jefferson University, Neonatology Department, Suite 727
Philadelphia, Pennsylvania, 19107
United States
New England Medical Center, Newborn Medicine, NEMC #84
Boston, Massachusetts, 02111
United States
Children's Hospital, Section of Neonatology
Columbus, Ohio, 43205-2696
United States
University of Cincinnati, College of Medicine, Department of Pediatrics
Cincinnati, Ohio, 45267-0541
United States
Stanford University Medical Center, Division of Neonatology
Palo Alto, California, 94304
United States
Kapiolani Medical Center
Honolulu, Hawaii, 96826
United States
University of Louisville, School of Medicine, Ophthalmology and Visual Sciences
Louisville, Kentucky, 40292
United States
University of Minnesota, Department of Ophthalmology
Minneapolis, Minnesota, 55455-0591
United States
University of Arkansas, Department of Ophthalmology
Little Rock, Arkansas, 72205
United States
Additional Information:
Study ID Numbers: NEI-40;
Study Start Date: May 1997
Record last reviewed: February 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000141
Other Retinopathy Of Prematurity Studies:
1. The Effects of Light Reduction on Retinopathy of Prematurity (Light-ROP)
2. Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial)
3. Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) - Outcome Study of Cryotherapy for Retinopathy of Prematurity
4. The Early Treatment for Retinopathy of Prematurity Study (ETROP)
Related Studies:
Other Retinopathy of Prematurity Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (the STOP-ROP Multicenter Trial)
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