Clinical Trial: Closure of Patent Ductus Arteriosus With Indomethacin or Ibuprofen in Extreme Low Birth Weight Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Ibupr

Brief 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.

Detailed Summary: 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.
Sponsor: Taipei Medical University Hospital

Current Primary Outcome: Number of infants with ductus closure [ Time Frame: 6 months ]

To compare the number of infants with ductus closure treated with indomethacin and ibuprofen in extremely low birth weight infants.


Original Primary Outcome: Same as current

Current Secondary Outcome: Urine output [ Time Frame: 1 month ]

To compare the urine output between indomethacin and ibuprofen treatment in extremely low birth weight infants.


Original Secondary Outcome: Renal function, utine output and serum BUN and creatinine [ Time Frame: 6 months ]

To compare the renal function between indomethacin and ibuprofen treatment in extremely low birth weight infants.


Information By: Taipei Medical University Hospital

Dates:
Date Received: December 16, 2012
Date Started: February 2007
Date Completion:
Last Updated: January 1, 2013
Last Verified: December 2012