Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants

Stopped early

Conditions studied: Retinopathy of Prematurity (ROP), Intraventricular Hemorrhage, Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity

In brief

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.

Key facts

Study ID

NCT04506619

Run by

Oak Hill Bio Ltd

People needed

26

Starts

2020-09-09

Expected to finish

2022-08-05

Last updated by the study team

2023-03-24

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Memorial Hospital of South Bend — South Bend, Indiana, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Azienda Ospedaliera Universitaria Careggi — Florence, Italy
• Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN — Genova, Italy
• Presidio Ospedaliero Di Treviso Ca' Foncello — Treviso, Italy
• Ashford and St. Peter's Hospitals NHS Trust - St. Peter*s Hospital — Chertsey, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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