Trial record 14 of 53 for:    "Patent ductus arteriosus"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hamidreza Mahboobi, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01511887
First received: January 13, 2012
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Patent Ductus Arteriosus
Drug: Oral Ibuprofen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hormozgan University of Medical Sciences:

Primary Outcome Measures:
  • PDA closure after 1 week [ Time Frame: 1 weeks after treatment ] [ Designated as safety issue: No ]
    PDA closure after 1 week of treatment based on echocardiography

  • PDA closure after two weeks [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
    PDA closure two weeks after treatment based on echocardiography


Secondary Outcome Measures:
  • Drug side effects [ Time Frame: two weeks after treatment ] [ Designated as safety issue: Yes ]
    hemorrhage, abdominal distention, oliguria


Enrollment: 40
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: Advil
No Intervention: No treatment
No treatment

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.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511887

Locations
Iran, Islamic Republic of
Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 097145-3388
Sponsors and Collaborators
Hormozgan University of Medical Sciences
Investigators
Principal Investigator: Hamidreza Mahboobi, MD Hormozgan University of Medical Sciences (HUMS)
  More Information

No publications provided

Responsible Party: Hamidreza Mahboobi, Principal Investigator, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01511887     History of Changes
Other Study ID Numbers: Ibuprofen in PDA
Study First Received: January 13, 2012
Last Updated: January 19, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Hormozgan University of Medical Sciences:
Patent Ductus Arteriosus
PDA
Term newborns
Ibuprofen

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014