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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01511887

Enrollment

Registered

2012-01-19

Start date

2011-01-31

Completion date

2012-01-31

Last updated

2012-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus

Keywords

Patent Ductus Arteriosus, PDA, Term newborns, Ibuprofen

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.

Interventions

DRUGOral 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Days to 28 Days

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Drug side effects	two weeks after treatment	hemorrhage, abdominal distention, oliguria

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026