drugset / Trial / NCT01758913
Closure of Patent Ductus Arteriosus With Indomethacin or Ibuprofen in Extreme Low Birth Weight Infants
Completed
110 enrolled
Taipei Medical University Hospital
China Medical University Hospital · collabCook County Health · collab
NaSingle-groupOpen-labelTreatment
Summary
Pharmacological closure of ductus arteriosus with prostaglandin (PG) inhibitors has been used for years. Previous studies indicated that ibuprofen has similar effect on ductal closure as indomethacin but has less adverse effects on renal function, cerebral blood flow and mesenteric blood flow.1-7 There are, however, very few studies being done specifically on extremely low birth weight (ELBW) infant \< 1000 g. This group of infants has immature kidney and often has poor response to PG inhibitors and has high mortality and morbidity. We hypothesized that, in ELBW infants, the ductal and renal response to PG inhibitors may be different between indomethacin and ibuprofen.
Timeline
- Start
- 2007-02
- Primary completion
- 2012-02
- Completion
- 2012-02
Publications
- Background Yeh TF, Achanti B, Patel H, Pildes RS. Indomethacin therapy in premature infants with patent ductus arteriosus--determination of therapeutic plasma levels. Dev Pharmacol Ther. 1989;12(4):169-78.
- Background Yeh TF, Raval D, Luken J, Thalji A, Lilien L, Pildes RS. Clinical evaluation of premature infants with patent ductus arteriosus: a scoring system with echocardiogram, acid-base, and blood gas correlations. Crit Care Med. 1981 Sep;9(9):655-7. doi: 10.1097/00003246-198109000-00009.
- Background Yeh TF, Luken J, Raval D, Thalji A, Carr I, Pildes RS. Indomethacin treatment in small versus large premature infants with ductus arteriosus. Comparison of plasma indomethacin concentration and clinical response. Br Heart J. 1983 Jul;50(1):27-30. doi: 10.1136/hrt.50.1.27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibuprofen | Small molecule | 5 mg/kg | — |