Patent Ductus Arteriosus Clinical Trial
Official title:
Ibuprofen vs. Indomethacin as Second Course of Therapy for Resistant PDA in Low Birth Weight Neonates
Patency of the ductus arteriosus (PDA) is functionally essential for fetal circulation,
however persistence of ductal patency postnatally may have significant adverse hemodynamic
effects in the neonate. Medical therapy for PDA predominantly involves the administration of
one of two non-steroidal anti-inflammatory drugs: indomethacin or ibuprofen. Both of these
therapies have been shown to be successful in mediating ductal closure in approximately 70%
of treated infants.
However, the need for a second course of treatment for PDA closure remains quite common. The
investigators hypothesize that, because of small differences between the two drugs, a
greater percentage of infants who did not respond to a first course of therapy with
indomethacin will respond to a second course with ibuprofen than to a repeat course of
indomethacin.
As such, the investigators aim to compare secondary therapy with a repeat course of
indomethacin to secondary therapy with ibuprofen in infants whose ductus remained patent
after a first course of therapy with indomethacin.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel 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 |
NCT03551600 -
Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
|
||
| Completed |
NCT02621528 -
Lifetech CeraFlex™ Post-Market Surveillance Study
|
N/A | |
| 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.
|