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Nitric Oxide, Endothelin-1, and the Patency of Ductus Arteriosus in Preterm Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00162903
First Posted: September 13, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose

BACKGROUND Patent ductus arteriosus (PDA) is a frequent clinical event in preterm infant. The cardiopulmonary functions of these preterm babies may be adversely affected by the patency of ductus arteriosus. Ductal tissues are sensitive to the constricting effect of endothelin-1 and the dilating effect of prostaglandins, inflammatory mediators, and concentration of oxygen.

OBJECTIVE To examine the role of endogenous nitric oxide (NO) and endothelin-1 (ET-1) in the pathogenesis of patent ductus arteriosus of the preterm infants. We hypothesize that the patency of ductus arterious in preterm infants is probably due to inappropriate production of endogenous nitric oxide and the interaction with various inflammatory mediators and prostaglandins, which is different from those of term infants. In addition, the secretion of endothelin is probably decreased. The purpose of this study is to monitor the changes of these substance sequentially, and to evaluate the relationship among endothelin-1, endogenous nitric oxide, and inflammatory mediators in the pathophysiology of patent ductus arteriosus in preterm infants.

METHODS AND MATERIALS

  1. Inclusion criteria:

    1. Preterm infants with gestational age less than 32 weeks or birth weight less than 2000 gm.
    2. Informed consent
  2. Numbers of study population:

    With 80-100 evaluable infants (40-50 patients in PDA and non-PDA groups, respectively)

  3. Blood sample, collecting on day 1,3,7 after regular echocardiographic evaluation, is assessed for inflammatory mediator (IL-8, IL-10), nitric oxide metabolites (nitrite and nitrate), endothelin-1, and cGMP
  4. Statistical analysis: Student t-test testing the differences of clinical data, Wilcoxon signed rank test for comparing data obtained between the PDA and non-PDA patients, the PDA patients before and after intravenous indomethacin, and those who are responsive or refractory to the therapy.

Condition
Patent Ductus Arteriosus

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: The Role of Nitric Oxide, Endothelin-1, and Inflammatory Mediators in the Patency of Ductus Arteriosus in Preterm Infants

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 80
Study Start Date: January 2002
Estimated Study Completion Date: December 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of the patency of ductus arteriosus

Exclusion Criteria:

  • Congenital anomalies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162903


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Wu Shiun Hsieh, M.D National Taiwan University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00162903     History of Changes
Other Study ID Numbers: 26955
First Submitted: September 12, 2005
First Posted: September 13, 2005
Last Update Posted: December 9, 2005
Last Verified: October 2001

Keywords provided by National Taiwan University Hospital:
Preterm infant, Patent ductus arteriosus, Nitric oxide,Endothelin-1

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents