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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
Hormozgan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Days - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

First Posted
January 13, 2012
Last Updated
January 19, 2012
Sponsor
Hormozgan University of Medical Sciences
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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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