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Completed

NCT Number: NCT01511887

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

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.

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Key information

Conditions

Patent Ductus Arteriosus Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases

Age range

20 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hormozgan University of Medical Sciences

Bandar Abbas, Hormozgan, 097145-3388, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral ibuprofen

Drug

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.

Other names: Advil

Primary outcomes

  1. PDA closure after 1 week

    Time frame: 1 weeks after treatment

    PDA closure after 1 week of treatment based on echocardiography

  2. PDA closure after two weeks

    Time frame: 2 weeks after treatment

    PDA closure two weeks after treatment based on echocardiography

Secondary outcomes

  1. Drug side effects

    Time frame: two weeks after treatment

    hemorrhage, abdominal distention, oliguria

Sponsors and collaborators

Lead sponsor

Hormozgan University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jan 19, 2012
Registry last updated
Jan 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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