STOP-ROP PARTICIPATING CLINICAL CENTER
STOP-ROP PARTICIPATING CLINICAL CENTER
批准号:
2163657
负责人:
MICHAEL J SHAPIRO
金额:
$22.51万
依托单位国家:
美国
项目类别:
财政年份:
1995
资助国家:
美国
项目状态:
已结题
起止时间:
1995-09-30 至 1998-09-29
中文摘要
描述(研究者摘要)“本提案请求支持
英文摘要
DESCRIPTION (Investigator's Abstract) "This proposal requests support
for the University of Illinois College of Medicine as a Participating
Center in the Supplemental Therapeutic Oxygen for Prethreshold
Retinopathy of Prematurity (STOP-ROP) Study. The application documents
this center's ability to recruit a projected 12 eligible infants per
year. This center will participate with the Study Headquarters in
Rochester, New York and the Coordinating Center at the EMMES Corporation
in Maryland, and will comply with the study design and Manual of
Operations which will be submitted separately by the Headquarters and
Coordinating Center.
Retinopathy of Prematurity (ROP) remains a serious public health problem
causing significant visual sequelae in an estimate 3400 premature infant
survivors per year in the United States, despite the accepted use of
Cryotherapy. Case control studies in premature infants, anecdotal
reports of successful treatment of ROP with oxygen, and studies
conducted in experimental models demonstrate that chronic (weeks-long)
hypoxia during the healing process is associated with retinopathies that
progresses rather than regresses. This hypothesis is also supported by
the association of proliferative retinopathies with retinal ischemia in
other disorders such as diabetic or sickle cell retinopathies.
Therefore, we proposed to test the hypothesis that 'Supplemental Oxygen
Treatment of Prethreshold ROP will result in a reduction by at least one
third in the number of infants with one or both eyes progressing to
severe ROP (Threshold).'
Infants who develop moderate ROP (Prethreshold as defined in the CRYO-
ROP study) will receive continuous pulse oximetry saturation monitoring
and be randomly assigned to oxygen administration at one of two
specified oxygen levels: conventional vs supplemental. Their ROP
status will be measured and recorded prospectively, and the primary
outcome will be the proportion of infants who progress to Threshold ROP
in at least one eye. Follow-up will continue to three months following
the projected time of full term delivery. The projected sample sizes are
compatible with a 2-3 year enrollment with 20- 30 participating centers.
Should this approach prove effective, the additional oxygen is also
expected to benefit through the reduction of cor pulmonale associated
with bronchopulmonary dysplasia often observed in these infants."
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STOP-ROP PARTICIPATING CLINICAL CENTER
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批准号:2163658
-
项目类别:
-
资助金额:$22.41万
-
财政年份:1995
-
负责人:MICHAEL J SHAPIRO
-
依托单位:
STOP ROP PARTICIPATING CLINICAL CENTER
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批准号:2871263
-
项目类别:
-
资助金额:$14.16万
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财政年份:1995
-
负责人:MICHAEL J SHAPIRO
-
依托单位:
STOP-ROP PARTICIPATING CLINICAL CENTER
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批准号:2647989
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项目类别:
-
资助金额:$18.69万
-
财政年份:1995
-
负责人:MICHAEL J SHAPIRO
-
依托单位:
海外基金