Possible Relation of Toll-Like Receptors and Nitric Oxide to Chronic Lung Disease

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00245167
First received: October 26, 2005
Last updated: March 3, 2008
Last verified: March 2008
  Purpose

The first objective of this study is to determine if increased expression of one or more members of the toll-like receptor (TLR) family of receptors that are found on inflammatory cells (present in the airway) precede development of chronic lung disease (CLD) of prematurity. The study will also determine if there is a significant correlation between TLRs and the severity of CLD. The second objective of this study is to determine the impact of c-administration of inhaled nitric oxide (INO) on TLR expression in infants at risk of developing CLD or with early CLD.


Condition Intervention
Lung Diseases
Procedure: Tracheal Aspirate Fluid

Study Type: Observational
Official Title: TLR's, Nitric Oxide and Chronic Lung Disease: Any Connections?

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Estimated Enrollment: 120
Study Start Date: January 2002
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

This study will examine the role of two members in the family of transmembrane receptors, TLRs, found on leukocytes and other cells that are upregulated in response to endotoxin and other stimuli. These substances transfer the signals that propagate inflammation and production of inflammatory cytokines. CLD of prematurity is characterized by early (first week of life) evidence of lung airway inflammation. It is unknown if TLR family members propagate this pathway.

DESIGN NARRATIVE:

This study will involve saving weekly tracheal aspirate fluid samples obtained with routine airway toilet in infants less than or equal to 1250 gm birth weight, who are admitted to a Neonatal Intensive Care unit requiring assisted ventilation via an endotracheal tube. The waste sample will be collected with the cellular contents separated by centrifugation and placed on Trizol reagent after obtaining a cell count. Later extraction and batch analysis of TLR, mRNA, and proteins as well as mRNA and protein for housekeeping genes will be performed. Immunohistochemistry will also be used to semi-quantitate the samples. Samples will be obtained in the first one to two days, and again at the end of the first week of life. In infants who were also participating in the related "Low Dose INO in CLD of Prematurity" study, in which tracheal aspirate samples were collected, when the code is broken to determine who received nitric oxide versus placebo, the second aim of the study will be carried out: to determine the impact, if any, of INO.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Birth weight less than 1250 gm
  • Requiring assisted ventilation

Exclusion Criteria:

  • Moribund condition
  • Major pulmonary or cardiovascular associated anomaly
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245167

Locations
United States, Missouri
Children's Mercy Hospital & Clinic
Kansas City, Missouri, United States, 64108
United States, Washington
Children's Hospital and Regional Medical Center (Seattle)
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Investigators
Principal Investigator: William E. Troug, MD Children's Mercy Hospital & Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00245167     History of Changes
Other Study ID Numbers: 1316, R01 HL070560
Study First Received: October 26, 2005
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on September 30, 2014