drugset / Trial / NCT00616382
Treating the Resistant Patent Ductus Arteriosus (PDA)
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2008-03
- Primary completion
- 2010-03
- Completion
- —
Publications
- Results Sperandio M, Beedgen B, Feneberg R, Huppertz C, Brussau J, Poschl J, Linderkamp O. Effectiveness and side effects of an escalating, stepwise approach to indomethacin treatment for symptomatic patent ductus arteriosus in premature infants below 33 weeks of gestation. Pediatrics. 2005 Dec;116(6):1361-6. doi: 10.1542/peds.2005-0293.
- Results Gonzalez A, Sosenko IR, Chandar J, Hummler H, Claure N, Bancalari E. Influence of infection on patent ductus arteriosus and chronic lung disease in premature infants weighing 1000 grams or less. J Pediatr. 1996 Apr;128(4):470-8. doi: 10.1016/s0022-3476(96)70356-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indomethacin | Small molecule | 0.2 mg/kg | Intravenous |
| Subject | Indomethacin | Small molecule | 1 mg/kg | Intravenous |
| Subject | Pentoxifylline | Small molecule | 5 mg/kg | — |