Safety and Efficacy of Ibuprofen in Term Newborns With Patent Ductus Arteriosus (PDA)

Patent Ductus Arteriosus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511887
• Other study ID #: Ibuprofen in PDA
• Status: Completed
• Phase: N/A
• First received: January 13, 2012
• Last updated: January 19, 2012
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Hormozgan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Drug:
• Oral Ibuprofen
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hormozgan University of Medical Sciences	Bandar Abbas	Hormozgan

Sponsors (1)

Lead Sponsor	Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PDA closure after 1 week	PDA closure after 1 week of treatment based on echocardiography	1 weeks after treatment	No
Primary	PDA closure after two weeks	PDA closure two weeks after treatment based on echocardiography	2 weeks after treatment	No
Secondary	Drug side effects	hemorrhage, abdominal distention, oliguria	two weeks after treatment	Yes