Closure of Patent Ductus Arteriosus With Indomethacin or Ibuprofen in Extreme Low Birth Weight Infants
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacological Closure of Patent Ductus Arteriosus in Extreme Low Birth Weight Infants. A Comparison of Efficacy, Side Effects and Outcomes Between Indomethacin and Ibuprofen|
- Number of infants with ductus closure [ Time Frame: 6 months ] [ Designated as safety issue: No ]To compare the number of infants with ductus closure treated with indomethacin and ibuprofen in extremely low birth weight infants.
- Urine output [ Time Frame: 1 month ] [ Designated as safety issue: No ]To compare the urine output between indomethacin and ibuprofen treatment in extremely low birth weight infants.
- Serum creatinine [ Time Frame: 1 month ] [ Designated as safety issue: No ]To compare serum creatinine between indomethacin and ibuprofen treatment in extremely low birth weight infants.
|Study Start Date:||February 2007|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Infant who was assigned to ibuprofen, an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 hours respectively as a course was given.
To compare the efficacy, the side effects and the renal prostaglandin (PG) excretion between indomethacin and ibuprofen in extremely low birth weight (ELBW) infants.
Other Name: 2-[4-(2-methylpropyl)phenyl]propanoic acid
The aims of this study are to compare the efficacy, the side effects and the renal prostaglandin (PG) excretion between indomethacin and ibuprofen in extremely low birth weight (ELBW) infants. We enrolled one hundred and ten ELBW infants who had clinically significant and echo-evidence patent ductus arteriosus were assigned into 2 groups, 56 received indomethacin (0.2 mg/kg, 0.1 mg/kg and 0.1 mg/kg in 24 hours interval) and 54 received ibuprofen (10 mg/kg, 5mg/kg and 5 mg/kg in 24 hours interval). Serum electrolytes, creatinine, renal function (urine output, glomerular filtration rate (GFR), fractional excretion of sodium and potassium, osmolar clearance and free water clearance), urinary PG excretion, pulmonary outcome and mortality were all evaluated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758913
|United States, Illinois|
|John H. Stroger, Jr. Hospital of Cook County|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Tsu-Fu Yeh, MD, PhD||Taipei Medical University|