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

Hormozgan University of Medical Sciences

Status: Completed

Conditions: Patent Ductus Arteriosus

Treatments: Drug: Oral Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT01511887

Ibuprofen in PDA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 28 days old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Oral Ibuprofen

Experimental group

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.

Treatment:

Drug: Oral Ibuprofen

No treatment

No Intervention group

Description:

No treatment