Nitric Oxide, Endothelin-1, and the Patency of Ductus Arteriosus in Preterm Infants
Information source: National Taiwan University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patent Ductus Arteriosus
Phase: N/A
Status: Completed
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s):
Wu Shiun Hsieh, M.D, Study Director, Affiliation: National Taiwan University Hospital
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.
Clinical Details
Official title: The Role of Nitric Oxide, Endothelin-1, and Inflammatory Mediators in the Patency of Ductus Arteriosus in Preterm Infants
Study design: Natural History, Cross-Sectional, Defined Population, Prospective Study
Eligibility
Minimum age: N/A.
Maximum age: 1 Year.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of the patency of ductus arteriosus
Exclusion Criteria:
- Congenital anomalies
Locations and Contacts
Additional Information
Starting date: January 2002
Ending date: December 2002
Last updated: November 22, 2005
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