NCT00245167

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

July 29, 2016

Status Verified

March 1, 2008

Enrollment Period

4.3 years

First QC Date

October 26, 2005

Last Update Submit

July 28, 2016

Conditions

Lung Diseases

Interventions

Tracheal Aspirate FluidPROCEDURE

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight less than 1250 gm
  • Requiring assisted ventilation

You may not qualify if:

  • Moribund condition
  • Major pulmonary or cardiovascular associated anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Mercy Hospital & Clinic

Kansas City, Missouri, 64108, United States

Location

Children's Hospital and Regional Medical Center (Seattle)

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • William E. Troug, MD

    Children's Mercy Hospital & Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 26, 2005

First Posted

October 27, 2005

Study Start

January 1, 2002

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

July 29, 2016

Record last verified: 2008-03

Locations

US(2)