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

Not Applicable

Completed

• Conditions: Patent Ductus Arteriosus
• Interventions: Drug: Oral Ibuprofen

• Registration Number: NCT01511887
• Lead Sponsor: Hormozgan University of Medical Sciences

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-12
• Status Verified: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-19
• Last Update Submitted: 2012-01-19
• Last Update Posted: 2012-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Ibuprofen	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.

Primary Outcome Measures

Name	Time	Method
PDA closure after 1 week	1 weeks after treatment	PDA closure after 1 week of treatment based on echocardiography
PDA closure after two weeks	2 weeks after treatment	PDA closure two weeks after treatment based on echocardiography

Secondary Outcome Measures

Name	Time	Method
Drug side effects	two weeks after treatment	hemorrhage, abdominal distention, oliguria

Trial Locations

Locations (1)

Hormozgan University of Medical Sciences; 🇮🇷 Bandar Abbas, Hormozgan, Iran, Islamic Republic of