NL-OMON42024
Completed
Phase 2
ong-term Outcome of Children Enrolled in Study ROPP-2008-01 Previously Treated with rhIGF-1/rhIGFBP-3 for the Prevention of Retinopathy of Prematurity (ROP) or Who Received Standard Neonatal Care - Shire SHP-607-201
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Retinopathy of prematurity
- Sponsor
- Shire
- Enrollment
- 8
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject was randomized in Study ROPP\-2008\-01, Section D
- •2\. Subject\*s parent or legally authorized representative(s) must provide written informed consent prior to performing any study\-related activities. Study\-related activities are any procedures that would not have been performed during normal management of the subject.
Exclusion Criteria
- •1\. Any other condition or therapy that, in the Investigator\*s opinion, may pose a risk to the subject or interfere with the subject\*s ability to be compliant with this protocol or interfere with the interpretation of results
- •2\. The subject or subject\*s parent or legally authorized representative(s) is unable to comply with the protocol as determined by the Investigator
Outcomes
Primary Outcomes
Not specified
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ong-term Outcome of Children Enrolled in Study ROPP-2008-01 Previously Treated with rhIGF-1/rhIGFBP-3 for the Prevention of Retinopathy of Prematurity (ROP) or Who Received Standard Neonatal CareEUCTR2014-003556-31-PLPremacure AB, A Member of the Shire Group of Companies120
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