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

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ClinicalTrials.gov Identifier: NCT00162903
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : November 23, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Study Description
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Brief Summary:

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 or disease
Patent Ductus Arteriosus

Study Design
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Study Type : Observational
Enrollment : 80 participants
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
Study Start Date : January 2002
Study Completion Date : December 2002

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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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
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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
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Study Director: Wu Shiun Hsieh, M.D National Taiwan University Hospital
More Information
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ClinicalTrials.gov Identifier: NCT00162903    
Other Study ID Numbers: 26955
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: November 23, 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:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities