Status:
COMPLETED
Telemedicine Approaches to Evaluating Acute-phase ROP
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Johns Hopkins University
Boston Children's Hospital
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
32-40 years
Brief Summary
The primary objective of this multi-center clinical study is to evaluate the validity, reliability, feasibility, safety and relative cost-effectiveness of a retinopathy of prematurity (ROP) telemedici...
Detailed Description
Eligibility Criteria: • Babies with birth weights of \<1251 grams(g) at selected large clinical centers in the US and Canada. Procedures: • Participants will undergo both digital retinal imaging an...
Eligibility Criteria
Inclusion
- Babies with birth weighs of \<1251g at selected large clinical centers in the US and Canada.
- Admitted to a participating Neonatal Intensive Care Units (NICU) and expected to survive to 28 days.
- Likely to remain in participating NICU for serial ROP exams.
- Transferred to participating NICU for treatment of ROP (regardless of PMA).
- Parents or guardians have provided informed consent for participation in the study.
Exclusion
- Failure to obtain informed consent.
- Known ocular anomalies that prevent imaging of the retina.
- Life threatening anomalies (i.e. heart, neurological, etc).
- Admission to participating NICU with ROP that is already regressing or treated.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT01264276
Start Date
July 1 2011
End Date
January 1 2014
Last Update
February 4 2015
Active Locations (12)
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1
University of Louisville
Louisville, Kentucky, United States, 40202
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455