Patent Ductus Arteriosus Clinical Trial
Official title:
Ibuprofen and Renal Function in Premature Infants
Purpose of the study:
1. To evaluate renal function maturation within the first month of life in very premature
infants.
2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would
alter renal function maturation at short term and up to 28 days of life.
Ibuprofen has improved the prognosis of infants with Patent Ductus Arteriosus. Several
studies showed that Ibuprofen has significantly less side effects than Indomethacin that was
used for this indication. However, experimental studies and few clinical observations
suggested that side effects on renal function could occur in very premature infants.
Purpose of the study:
1. To evaluate renal function maturation within the first month of life in very premature
infants.
2. To determine whether a treatment with Ibuprofen for patent ductus arteriosus would
alter renal function maturation at short term and up to 28 days of life.
Population:
At least 120 infants 27 to 31 weeks gestation will be studied. That number will allow to
demonstrate a 30% difference in creatinine clearance on day 7 postnatally. Careful recording
of mother and child history, and associated therapies prone to alter renal function should
allow to improve the use of this treatment.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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