Closure of Patent Ductus Arteriosus With Indomethacin or Ibuprofen in Extreme Low Birth Weight Infants
|ClinicalTrials.gov Identifier: NCT01758913|
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : January 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Patent Ductus Arteriosus||Drug: Ibuprofen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
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
- 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.
- Urine output [ Time Frame: 1 month ]To compare the urine output between indomethacin and ibuprofen treatment in extremely low birth weight infants.
- Serum creatinine [ Time Frame: 1 month ]To compare serum creatinine between indomethacin and ibuprofen treatment in extremely low birth weight infants.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|