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

Status Completed

Clinical Trial 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 Trial Description

n/a

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00162903
Study type	Observational
Source	National Taiwan University Hospital
Contact
Status	Completed
Phase	N/A
Start date	January 2002
Completion date	December 2002

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04986839` - PAIR (Paracetamol and Ibuprofen Research) Pilot Trial	Phase 2/Phase 3
Recruiting	`NCT03648437` - Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus	Phase 1
Completed	`NCT04126512` - Timing of Surgical PDA Ligation and Neonatal Outcomes
Not yet recruiting	`NCT06045130` - PUFAs in Preterm Infants
Completed	`NCT00217191` - Ibuprofen and Renal Function in Premature Infants	Phase 4
Not yet recruiting	`NCT02894970` - A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation	N/A
Completed	`NCT02621528` - Lifetech CeraFlex™ Post-Market Surveillance Study	N/A
Completed	`NCT03551600` - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Terminated	`NCT03982342` - Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants	N/A
Completed	`NCT01479218` - Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus	N/A
Completed	`NCT00795990` - Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants	N/A
Terminated	`NCT00802685` - Timing of PDA Closure and Respiratory Outcome in Premature Infants	N/A
Withdrawn	`NCT00554307` - Brain, Gut and Kidney Blood Flow During Medical Closure of PDA	N/A
Completed	`NCT03723889` - Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
Recruiting	`NCT04397913` - Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
Completed	`NCT02750228` - PDA Post NICU Discharge
Recruiting	`NCT02220270` - Hyperion™ International Registry Trial	N/A
Completed	`NCT01593163` - Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus	Phase 3
Recruiting	`NCT06298344` - The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease	Early Phase 1
Completed	`NCT03277768` - Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms