Brief Title
Closure of Patent Ductus Arteriosus With Indomethacin or Ibuprofen in Extreme Low Birth Weight Infants
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
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 Description
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.
Study Type
Interventional
Primary Outcome
Number of infants with ductus closure
Secondary Outcome
Urine output
Condition
Patent Ductus Arteriosus
Intervention
Ibuprofen
Study Arms / Comparison Groups
Ibuprofen
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
110
Start Date
February 2007
Completion Date
February 2012
Primary Completion Date
February 2012
Eligibility Criteria
Inclusion Criteria:
- The selection criteria were: (1) preterm infants with birth weight <1000 g; 2)
radiographic diagnosis of respiratory distress syndrome (RDS); (3) requirement of
mechanical ventilation and (4) echocardiographic and clinical evidence of significant
patent ductus arteriosus (PDA).
Exclusion Criteria:
- Exclusion criteria included: (1) evidence of infection or sepsis; 2) lethal congenital
anomalies; (3) oliguria (< 1 ml/kg/h) and/or serum creatinine > 2.0 mg/dl and (4) low
platelet count (< 50,000/mm3) or bleeding tendency.
Gender
All
Ages
N/A - 6 Months
Accepts Healthy Volunteers
No
Contacts
Tsu-Fu Yeh, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01758913
Organization ID
PDA Ind Ibu ELBW
Responsible Party
Sponsor
Study Sponsor
Taipei Medical University Hospital
Collaborators
John H. Stroger Hospital
Study Sponsor
Tsu-Fu Yeh, MD, PhD, Principal Investigator, Taipei Medical University
Verification Date
December 2012