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