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.
Who can participate
Age range23 Weeks – 26 Weeks
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Area under the curve from serial Indomethacin levels