NCT01511887

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

Evaluation of the Safety and Efficacy of Oral Ibuprofen in Term 20-28 Days Old Newborns Referred to Bandar Abbass Children Hospital in 2011

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hormozgan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 20 Days – 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-12-01
• Completion: 2012-01-01
• First posted: 2012-01-19
• Last updated: 2012-01-20

Locations

1 site across 1 country: Iran