Indomethacin PK-PD in Extremely Preterm Neonates (INDO)

University of Manitoba

Status and phase: Withdrawn; Phase 2

Conditions: Patent Ductus Arteriosus After Premature Birth

Treatments: Drug: Indomethacin Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04025177

B2018:095

Details and patient eligibility

About

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.

Full 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, neonates will receive intravenous indomethacin at a dose of 0.1mg/kg every 24 hours for 3 days. Indomethacin levels will be measured at regular intervals. Urine output and serum electrolytes will be monitored prior to each dose of indomethacin. An echocardiogram will be repeated after completion of indomethacin treatment (between 72-120 hours of age) to reassess the status of PDA.

Sex: All

Ages: 23 to 26 weeks old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Neonates with an open PDA

Experimental group

Description:

Neonates born between 23 (0/7) and 26 (6/7) weeks gestational age with an open PDA, according to clinical protocol criteria, and no contraindication to the use of indomethacin.

Treatment:

Drug: Indomethacin Injection