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

This study has been completed.
Sponsor:
Collaborators:
John H. Stroger Hospital
China Medical University Hospital
Information provided by (Responsible Party):
Taipei Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01758913
First received: December 16, 2012
Last updated: January 1, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention
Patent Ductus Arteriosus
Drug: Ibuprofen

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Taipei Medical University Hospital:

Primary Outcome Measures:
  • Number of infants with ductus closure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To compare the number of infants with ductus closure treated with indomethacin and ibuprofen in extremely low birth weight infants.


Secondary Outcome Measures:
  • Urine output [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    To compare the urine output between indomethacin and ibuprofen treatment in extremely low birth weight infants.


Other Outcome Measures:
  • Serum creatinine [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    To compare serum creatinine between indomethacin and ibuprofen treatment in extremely low birth weight infants.


Enrollment: 110
Study Start Date: February 2007
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Ibuprofen
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

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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01758913

Locations
United States, Illinois
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Taipei Medical University Hospital
John H. Stroger Hospital
China Medical University Hospital
Investigators
Principal Investigator: Tsu-Fu Yeh, MD, PhD Taipei Medical University
  More Information

Publications:
Responsible Party: Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT01758913     History of Changes
Other Study ID Numbers: PDA Ind Ibu ELBW
Study First Received: December 16, 2012
Last Updated: January 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Taipei Medical University Hospital:
Bronchopulmonary dysplasia
patent ductus arteriosus
prostaglandin
Respiratory distress syndrome

Additional relevant MeSH terms:
Birth Weight
Ductus Arteriosus, Patent
Body Weight
Signs and Symptoms
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cardiovascular Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on August 28, 2014