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

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.
 
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

Tracking Information
First Submitted Date September 12, 2005
First Posted Date September 13, 2005
Last Update Posted Date November 23, 2005
Study Start Date January 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Nitric Oxide, Endothelin-1, and the Patency of Ductus Arteriosus in Preterm Infants
Official Title The Role of Nitric Oxide, Endothelin-1, and Inflammatory Mediators in the Patency of Ductus Arteriosus in Preterm Infants
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Patent Ductus Arteriosus
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: September¬†12,¬†2005)
80
Original Enrollment Same as current
Study Completion Date December 2002
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of the patency of ductus arteriosus

Exclusion Criteria:

  • Congenital anomalies
Sex/Gender
Sexes Eligible for Study: All
Ages up to 1 Year   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00162903
Other Study ID Numbers 26955
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Study Director: Wu Shiun Hsieh, M.D National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date October 2001