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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-09

Study Completion Date

2022-08-05

Brief Summary

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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.

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Detailed Description

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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 investigational product in this study.

Conditions

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Retinopathy of Prematurity (ROP) Intraventricular Hemorrhage Bronchopulmonary Dysplasia Chronic Lung Disease of Prematurity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SHP607 250 mcg/kg/24 hours

Participants who received 250 micrograms per kilogram per 24 hours (mcg/kg/24 hours) in the previous study SHP607-202 (NCT03253263) will be followed into this long-term study SHP607-203.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

SHP607 400 mcg/kg/24 hours

Participants who received 400 mcg/kg/24 hours in the previous study SHP607-202 (NCT03253263) will be followed into this long-term study SHP607-203.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

Standard Neonatal Care

Participants who received standard neonatal care in the previous study SHP607-202 (NCT03253263) will be followed into this long-term study SHP607-203.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

Interventions

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No Intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

\- 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.

Minimum Eligible Age

12 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No