Study Stopped
As the revised OHB-607-202 protocol extends the study's observational arm through 24 months corrective age (CA), the SHP607-203 protocol was terminated at 24 months CA.
Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Long-Term Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
2 other identifiers
observational
26
3 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2020
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2020
CompletedFirst Posted
Study publicly available on registry
August 10, 2020
CompletedStudy Start
First participant enrolled
September 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2022
CompletedMarch 24, 2023
April 1, 2022
1.9 years
July 27, 2020
March 22, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
Number of Emergency Room Visits
Number of emergency room visits associated with a respiratory diagnosis will be reported.
12 months CA through 60 months CA
Number of Hospitalizations
Number of hospitalizations associated with a respiratory diagnosis will be reported.
12 months CA through 60 months CA
Incidence of Signs and Symptoms of Respiratory Disease
Incidence of signs and symptoms of respiratory disease (yes/no) is assessed by recording episodes of wheezing, coughing, and respiratory medication.
12 months CA through 60 months CA
Number of Days of Respiratory Medication Use
Number of days of respiratory medication use (for example, bronchodilators, steroids, leukotriene inhibitors, diuretics) will be reported.
12 months CA through 60 months CA
Total Number of Days on Home Respiratory Technology use
Total number of days on home respiratory technology use (for example, home oxygen, continuous positive airway pressure \[CPAP\], tracheostomy) will be reported.
12 months CA through 60 months CA
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
12 months CA through 60 months CA
Secondary Outcomes (18)
Growth Parameters: Body Weight
At 12, 24, and 60 months CA
Growth Parameters: Body Length
At 12 and 24 months CA
Growth Parameters: Height
At 60 months CA
Growth parameters: Head circumference
At 12 and 24 months CA
Physical Development as Assessed by Physical Examination
At 12, 24, and 60 months CA
- +13 more secondary outcomes
Study Arms (3)
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.
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.
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.
Interventions
This is a non-interventional study.
Eligibility Criteria
Participants who previously received SHP607 or standard neonatal care in Study SHP607-202 (NCT03253263) are planned to be enrolled in Study SHP607-203.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oak Hill Bio Ltdlead
Study Sites (8)
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genova, 16147, Italy
Presidio Ospedaliero Di Treviso Ca' Foncello
Treviso, 31100, Italy
Ashford and St. Peter's Hospitals NHS Trust - St. Peter*s Hospital
Chertsey, Surrey, KT16 0PZ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2020
First Posted
August 10, 2020
Study Start
September 9, 2020
Primary Completion
August 5, 2022
Study Completion
August 5, 2022
Last Updated
March 24, 2023
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share
De-identified individual participant data from this particular study will not be shared in order to minimize the risk that individual patients could be reidentified, given that there are limited numbers of study participants at each study site per year.