Patent Ductus Arteriosus
Conditions
Keywords
PDA, indomethacin, pentoxifylline, Patent Ductus Arteriosus [PDA] resistant to therapy
Brief summary
Persistent postnatal ductal patency may have significant adverse hemodynamic effects, frequently necessitating therapeutic intervention in order to facilitate ductal closure. Medical therapy for patency of the ductus arteriosus is successful mediating ductal closure in approximately 70% of treated infants. In a recent study in our population, 17% of the babies showed no ductal response to the first course of treatment and 9.4% of our study infants eventually underwent surgical ligation of the ductus after failure of medical therapeutic closure.We propose to evaluate and compare two alternate therapeutic approaches to ductal closure in babies who do not respond to initial therapy.
Interventions
DRUGIndomethacin
IV indomethacin starting at a dose of 0.4 mg/kg given over 30 minutes, increased daily by increments of 0.2 mg/kg/dose and given at intervals of 12 hours until a maximum dose of 1 mg/kg is reached, or until a total indomethacin dose of 6 mg/kg has been given. Daily echocardiography will be performed to monitor the progress of ductal closure. Once echocardiographic evidence of a closed ductus is achieved, two additional doses indomethacin will be given 24 hours and 48 hours later, using the same dose used in the last indomethacin infusion.
DRUGPentoxifylline
IV indomethacin will be re-started at a dose of 0.2 mg/kg to run over 30 minutes at 12 hour intervals to be given concurrently with pentoxifylline (5 mg/kg/hour to run over 6 hour once a day for a maximum of 6 days. Daily echocardiography will be performed to monitor the progress of ductal closure. Once echocardiographic evidence of a closed ductus is achieved, two additional doses indomethacin will be given 24 hours and 48 hours later and another day of pentoxifylline infusion, provided that the 6 day maximum has not yet been
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Days to 4 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Inborn premature neonates admitted to the neonatal intensive care unit of the Shaare Zedek Medical Center and diagnosed as having a hemodynamically significant patent ductus arteriosus (sPDA) will be considered as potential candidates for study if/when they do not respond to initial therapy
Exclusion criteria
* Any baby not considered viable * Any baby with IVH grade 3-4 of recent onset (within 3 days. \[If no head ultrasound has been performed within the last 3-4 days, one should performed prior to onset of study.\] * Any baby with dysmorphic features or congenital abnormalities * Any baby with structural heart disease other than PDA * Any baby with documented infection, * Any baby with thrombocytopenia (\<50,000).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary objective in this study is to improve ductal closure rates in those infants who do not respond to a first course of therapy. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Our secondary objective is to compare the therapeutic efficacy of two very different secondary treatment protocols. | 2 years |
| To monitor and compare potential side effects of the two treatment approaches | 2 years |
Countries
Israel
Contacts
Primary ContactCathy Hammerman, MD
Outcome results
None listed