Status:
WITHDRAWN
Indomethacin PK-PD in Extremely Preterm Neonates
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
St. Boniface Hospital
Health Sciences Centre, Winnipeg, Manitoba
Conditions:
Patent Ductus Arteriosus After Premature Birth
Eligibility:
All Genders
23-26 years
Phase:
PHASE2
Brief Summary
This is a phase II open-label study evaluating the pharmacokinetics and pharmacodynamics of targeted early use of indomethacin for PDA treatment in preterm neonates \<27 weeks' gestational age.
Detailed Description
Neonates will be enrolled following an echocardiogram performed within 12 hours after birth that confirms an open PDA (with no other contraindications for indomethacin treatment). After enrollment, ne...
Eligibility Criteria
Inclusion
- Male or female infant born between 23 (0/7) and 26 (6/7) week GA
- Infant diagnosed with PDA according to clinical protocol criteria
- Able to adhere to indomethacin administration protocol
- The patient is born in the study center.
- Subject's parent(s)/legal guardian(s) has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
- In the investigator's opinion, the subject's parent(s)/legal guardian(s) understand(s) and can comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.
Exclusion
- known major congenital malformations (renal, cardiac, gastrointestinal and central nervous system)
- genetic syndromes-inborn errors of metabolism
- severe renal compromise
- intrauterine growth retardation with birth weight \<3rd centile
- thrombocytopenia \<50,000/mm3
- moderate to severe pulmonary hypertension
- clinical sepsis -meningitis- hepatitis
- anticipated drug-drug-interactions (specifically CYP2C9, CYP2C19 and UGT 1-1)
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04025177
Start Date
January 1 2020
End Date
February 1 2022
Last Update
October 6 2021
Active Locations (2)
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1
St. Boniface General Hospital Research Centre
Winnipeg, Manitoba, Canada, R2H 2A6
2
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9