Awardee OrganizationUNIVERSITY OF ILLINOIS AT CHICAGO
Description
Abstract Text
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."
No Sub Projects information available for 5U10EY009940-02
Publications
Publications are associated with projects, but cannot be identified with any particular year of the project or fiscal year of funding. This is due to the continuous and cumulative nature of knowledge generation across the life of a project and the sometimes long and variable publishing timeline. Similarly, for multi-component projects, publications are associated with the parent core project and not with individual sub-projects.
No Publications available for 5U10EY009940-02
Patents
No Patents information available for 5U10EY009940-02
Outcomes
The Project Outcomes shown here are displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed are those of the PI and do not necessarily reflect the views of the National Institutes of Health. NIH has not endorsed the content below.
No Outcomes available for 5U10EY009940-02
Clinical Studies
No Clinical Studies information available for 5U10EY009940-02
News and More
Related News Releases
No news release information available for 5U10EY009940-02
History
No Historical information available for 5U10EY009940-02
Similar Projects
No Similar Projects information available for 5U10EY009940-02