Status:
TERMINATED
Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Lead Sponsor:
Oak Hill Bio Ltd
Conditions:
Retinopathy of Prematurity (ROP)
Intraventricular Hemorrhage
Eligibility:
All Genders
12-24 years
Brief Summary
The purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group.
Detailed Description
In this long-term follow-up study, participants who enrolled in SHP607-202 (NCT03253263) will be followed from 12 months corrected age (CA) through 60 months CA. Participants will not receive any inve...
Eligibility Criteria
Inclusion
- Participants who were randomized into Study SHP607-202 (NCT03253263). Participants who were randomized, but did not complete Study SHP607-202 (NCT03253263) must be at least 12 months CA.
- Written informed consents (and assents, if applicable) must be signed and dated by the participant's parent(s)/legally authorized representative(s) prior to any study-related procedures. The informed consent and any assents for underage parents must be approved by the institutional review board (IRB)/independent ethics committee (IEC).
Exclusion
- \- Participants are excluded from the study if the participant or participant's parent(s)/legally authorized representative(s) is/are unable to comply with the protocol or is/are unlikely to be available for long-term follow-up as determined by the investigator.
Key Trial Info
Start Date :
September 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 5 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04506619
Start Date
September 9 2020
End Date
August 5 2022
Last Update
March 24 2023
Active Locations (8)
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1
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
2
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
3
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
4
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901