Indomethacin PK-PD in Extremely Preterm Neonates

• Status: Withdrawn
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manitoba
• Collaborators: Health Sciences Centre, Winnipeg, Manitoba; St. Boniface General Hospital Research Centre; St. Boniface Hospital; University at Buffalo
• Treatments: Indomethacin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)