Patent Ductus Arteriosus Clinical Trial
Official title:
Randomized Pilot Study Comparing Oral Ibuprofen With Intravenous Ibuprofen in Very Low Birth Weight Infants With Patent Ductus Arteriosus
it is a prospective randomized simple-blinded pilot trial with the principal aim to compare efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative closure of PDA in very low birth weight infants. The likelihood of ductal closure with only one or two doses of treatment is a secondary objective.
We calculated that a study group of 62 patients would be necessary for the study to be able to detect a difference of at least 25 percentage points in the closure rate between the oral ibuprofen and intravenous ibuprofen groups, assuming a closure rate of 65 percent with intravenous ibuprofen, with a p value of 0, 05 and a power of 80 percent.Patients (gestational age, 25 to 32 weeks) with echocardiographically confirmed patent ductus arteriosus and respiratory distress will randomly be assigned to receive one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of either intravenous ibuprofen (group I, n = 32) or oral ibuprofen (group O, n = 32), starting on the third day of life. The rate of ductal closure, side effects, complications, and the patients' clinical course will be recorded. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), 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
|
||
| Completed |
NCT00217191 -
Ibuprofen and Renal Function in Premature Infants
|
Phase 4 | |
| 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.
|