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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04986839 -
PAIR (Paracetamol and Ibuprofen Research) Pilot Trial
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03648437 -
Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus
|
Phase 1 | |
| Completed |
NCT04126512 -
Timing of Surgical PDA Ligation and Neonatal Outcomes
|
||
| Not yet recruiting |
NCT06045130 -
PUFAs in Preterm Infants
|
||
| Not yet recruiting |
NCT02894970 -
A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation
|
N/A | |
| Completed |
NCT02621528 -
Lifetech CeraFlex™ Post-Market Surveillance Study
|
N/A | |
| Completed |
NCT03551600 -
Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
|
||
| Terminated |
NCT03982342 -
Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants
|
N/A | |
| Completed |
NCT01479218 -
Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus
|
N/A | |
| Completed |
NCT00795990 -
Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants
|
N/A | |
| Terminated |
NCT00802685 -
Timing of PDA Closure and Respiratory Outcome in Premature Infants
|
N/A | |
| Withdrawn |
NCT00554307 -
Brain, Gut and Kidney Blood Flow During Medical Closure of PDA
|
N/A | |
| Completed |
NCT03723889 -
Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
|
||
| Recruiting |
NCT04397913 -
Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
|
||
| Completed |
NCT02750228 -
PDA Post NICU Discharge
|
||
| Recruiting |
NCT02220270 -
Hyperion™ International Registry Trial
|
N/A | |
| Completed |
NCT01593163 -
Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus
|
Phase 3 | |
| Recruiting |
NCT06298344 -
The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease
|
Early Phase 1 | |
| Completed |
NCT03277768 -
Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.
|
||
| Completed |
NCT03022253 -
Platelet Transfusion for Treatment of Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates
|
Phase 3 |