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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2002-12-31

Brief Summary

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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

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Conditions

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Patent Ductus Arteriosus

Keywords

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Preterm infant, Patent ductus arteriosus, Nitric oxide,Endothelin-1

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of the patency of ductus arteriosus

Exclusion Criteria

* Congenital anomalies

Minimum Eligible Age

0 Years

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Wu Shiun Hsieh, M.D

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Other Identifiers

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26955

Identifier Type: -

Identifier Source: org_study_id