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

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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.

Study Type

Observational

Condition

Patent Ductus Arteriosus

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

80

Start Date

January 2002

Completion Date

December 2002

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical diagnosis of the patency of ductus arteriosus

        Exclusion Criteria:

          -  Congenital anomalies

Gender

All

Ages

N/A - 1 Year

Accepts Healthy Volunteers

No

Contacts

Wu Shiun Hsieh, M.D, ,

Administrative Informations

NCT ID

NCT00162903

Organization ID

26955

Study Sponsor

National Taiwan University Hospital

Study Sponsor

Wu Shiun Hsieh, M.D, Study Director, National Taiwan University Hospital

Verification Date

October 2001