Closure of Patent Ductus Arteriosus With Indomethacin or Ibuprofen in Extreme Low Birth Weight Infants
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|