Safety and Efficacy of Ibuprofen in Term Newborns With Patent Ductus Arteriosus (PDA)
Primary Purpose
Patent Ductus Arteriosus
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
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 Arteriosus, PDA, Term newborns, Ibuprofen
Eligibility Criteria
Inclusion Criteria:
- Term newborn (37 weeks of gestation or more)
- Age between 20-28 days
- confirmed diagnosis of PDA by echocardiography by pediatric cardiologist
Exclusion Criteria:
- Asphyxia
- Hemorrhage
- Platelet count < 150000
- renal or gastrointestinal malformations
- associated congenital heart disease
Sites / Locations
- Hormozgan University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Oral Ibuprofen
No treatment
Arm Description
10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated.
No treatment
Outcomes
Primary Outcome Measures
PDA closure after 1 week
PDA closure after 1 week of treatment based on echocardiography
PDA closure after two weeks
PDA closure two weeks after treatment based on echocardiography
Secondary Outcome Measures
Drug side effects
hemorrhage, abdominal distention, oliguria
Full Information
NCT ID
NCT01511887
First Posted
January 13, 2012
Last Updated
January 19, 2012
Sponsor
Hormozgan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01511887
Brief Title
Safety and Efficacy of Ibuprofen in Term Newborns With Patent Ductus Arteriosus (PDA)
Official Title
Evaluation of the Safety and Efficacy of Oral Ibuprofen in Term 20-28 Days Old Newborns Referred to Bandar Abbass Children Hospital in 2011
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hormozgan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.
Detailed Description
Patent Ductus Arteriosus (PDA) accounts for about 10% of Congenital Heart Disease. Surgical treatment in PDA is associated with higher rate of complication than pharmacologic treatment. Efficacy of Ibuprofen is shown in preterm and low birth weights newborn with PDA. Studies in term neonates after the first days of birth are rare. The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.
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 Arteriosus, PDA, Term newborns, Ibuprofen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Ibuprofen
Arm Type
Experimental
Arm Description
10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Drug
Intervention Name(s)
Oral Ibuprofen
Other Intervention Name(s)
Advil
Intervention Description
10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated.
Primary Outcome Measure Information:
Title
PDA closure after 1 week
Description
PDA closure after 1 week of treatment based on echocardiography
Time Frame
1 weeks after treatment
Title
PDA closure after two weeks
Description
PDA closure two weeks after treatment based on echocardiography
Time Frame
2 weeks after treatment
Secondary Outcome Measure Information:
Title
Drug side effects
Description
hemorrhage, abdominal distention, oliguria
Time Frame
two weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Days
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Term newborn (37 weeks of gestation or more)
Age between 20-28 days
confirmed diagnosis of PDA by echocardiography by pediatric cardiologist
Exclusion Criteria:
Asphyxia
Hemorrhage
Platelet count < 150000
renal or gastrointestinal malformations
associated congenital heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamidreza Mahboobi, MD
Organizational Affiliation
Hormozgan University of Medical Sciences (HUMS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hormozgan University of Medical Sciences
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
097145-3388
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Ibuprofen in Term Newborns With Patent Ductus Arteriosus (PDA)
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