Efficacy and Safety of Oral Versus Intravenous Ibuprofen for PDA Treatment in ELBW Infants
Primary Purpose
Patent Ductus Arteriosus
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
oral ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring Patent ductus arteriosis, İbuprofen, Extremely Low Birth Weigh infant
Eligibility Criteria
Inclusion Criteria:
- Birth weight below 1000 gram
- Diagnosed patent ductus arteriosis by Echocardiographic examination
Exclusion Criteria:
- Accompanied other congenital cardiac anomalies
- Severe thrombocytopenia < 60.000
- Severe intracranial bleeding (Grade 3-4)
- Intestinal abnormality and necrotising enterocolitis
Sites / Locations
- Zekai Tahir Burak Maternity Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
intravenous ibuprofen
Oral ibuprofen
Arm Description
Extremely low birth weight patients receiving iv ibuprofen
Extremely low birth weight patients receiving oral ibuprofen
Outcomes
Primary Outcome Measures
Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575
To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment
Secondary Outcome Measures
Efficacy and Safety of Oral Versus Intravenous Ibuprofen
Evaluation of renal tolerance and complications
Full Information
NCT ID
NCT01261117
First Posted
November 29, 2010
Last Updated
August 8, 2011
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01261117
Brief Title
Efficacy and Safety of Oral Versus Intravenous Ibuprofen for PDA Treatment in ELBW Infants
Official Title
Oral Versus Intravenous Ibuprofen Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.
Detailed Description
To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.Seventy ELBW preterm infants with patent ductus arteriosis will be enrolled in this prospective-randomized study. Patients will receive either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
One of the following echocardiographic criteria of a duct size >1.5 mm, a left atrium-to-aorta ratio >1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of ibuprofen treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus
Keywords
Patent ductus arteriosis, İbuprofen, Extremely Low Birth Weigh infant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intravenous ibuprofen
Arm Type
Active Comparator
Arm Description
Extremely low birth weight patients receiving iv ibuprofen
Arm Title
Oral ibuprofen
Arm Type
Active Comparator
Arm Description
Extremely low birth weight patients receiving oral ibuprofen
Intervention Type
Drug
Intervention Name(s)
oral ibuprofen
Intervention Description
oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals
Primary Outcome Measure Information:
Title
Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575
Description
To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Efficacy and Safety of Oral Versus Intravenous Ibuprofen
Description
Evaluation of renal tolerance and complications
Time Frame
Results will be identified in 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Birth weight below 1000 gram
Diagnosed patent ductus arteriosis by Echocardiographic examination
Exclusion Criteria:
Accompanied other congenital cardiac anomalies
Severe thrombocytopenia < 60.000
Severe intracranial bleeding (Grade 3-4)
Intestinal abnormality and necrotising enterocolitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Erdeve
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital
City
Ankara
ZIP/Postal Code
06600
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Oral Versus Intravenous Ibuprofen for PDA Treatment in ELBW Infants
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