Patent Ductus Arteriosus
Conditions
Keywords
PDA, Paracetamol, Indomethacin, Ibuprofen
Brief summary
The investigators propose that paracetamol will be similarly effective to ibuprofen in treating PDA in the premature neonate, with fewer side effects.
Detailed description
Preterm neonates with a hemodynamically significant PDA will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1.po Paracetamol at a dose of 15 mg/kg every 6 hours at x 3 days or Group 2- IV indomethacin - 0.2 mg/kg/dose q 12h for three doses; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).Clinical staff will be blinded as to the study group assignment of the babies and since the group 1 drug is to be given every six hours, all babies will receive a parenteral substance every 6 hours. For Group 2 infants, the intermittent doses will be IV D5W alternating with drug.All infants will fed trophic feeds (20 cc/kg/day) during the treatment for ductal closure.
Interventions
DRUGParacetamol
po Paracetamol 15 mg/kg every 6 hours x 3 days
DRUGNSAID
IV indomethacin 2 mg/kg/dose for three doses at 12 hour intervals; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).
DRUGD5W
Since the paracetamol is given q 6 hours, in order to maintain blinding of the clinical staff, a placebo (D5W) must be given intermittently between the doses of NSAID such that each infant will receive drug every 6 hours.
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Days to 2 Weeks
Healthy volunteers
No
Inclusion criteria
* Echocardiographic diagnosis of hemodynamically significant patent ductus arteriosus
Exclusion criteria
* Major congenital anomalies * Life-threatening infection * Active NEC and/or intestinal perforation * Recent (within the previous 24 hours) intraventricular hemorrhage Grade 3-4 * Urine output \<1 ml per kilogram per hour during the preceding 8 hours * Serum creatinine concentration of \>1.6 mg % * Platelet count of \<60,000 per cc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Closure of the Ductus | 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of peripheral vasoconstriction | 48 hours | Doppler flow velocity in anterior cerebral artery, superior mesenteric artery and renal artery will be measured before and after pharmacologic treatment. |
| Absence of hepatotoxicity | 1 week | Liver function will be compared between the two study groups at 1 week following completion of pharmacologic treatment |
Countries
Israel
Contacts
Primary ContactCathy Hammerman, MD
Backup ContactAlona Bin-Nun, MD
Outcome results
None listed