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

Not Applicable

Completed

• Conditions: Patent Ductus Arteriosus
• Interventions: Drug: Ibuprofen

• Registration Number: NCT01758913
• Lead Sponsor: Taipei Medical University Hospital

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 Timeline

• Study Start: 2007-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-12
• Study First Submitted: 2012-12-16
• Study First Submitted QC: 2012-12-27
• Study First Posted: 2013-01-01
• Last Update Submitted: 2013-01-01
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ibuprofen	Ibuprofen	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.

Primary Outcome Measures

Name	Time	Method
Number of infants with ductus closure	6 months	To compare the number of infants with ductus closure treated with indomethacin and ibuprofen in extremely low birth weight infants.

Secondary Outcome Measures

Name	Time	Method
Urine output	1 month	To compare the urine output between indomethacin and ibuprofen treatment in extremely low birth weight infants.

Trial Locations

Locations (1)

John H. Stroger, Jr. Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States