NCT00570297

Brief Summary

Bronchiolitis is a significant cause of morbidity and hospitalization in children, accounting for approximately 125,000 hospitalizations per year in the U.S. Recently, genetic variations of the β2-adrenergic receptor (β2-AR) have been shown to influence response to β2-AR agonist therapy in children with asthma. We suspect that genetic variations of the β2-AR also affect response to β2-AR agonist therapy in children with bronchiolitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

December 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2007

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

November 30, 2023

Status Verified

October 1, 2022

Enrollment Period

10.3 years

First QC Date

December 6, 2007

Last Update Submit

November 27, 2023

Conditions

Bronchiolitis

Keywords

PediatricPolymorphism, GeneticAdrenergic beta-Agonists

Outcome Measures

Primary Outcomes (1)

  • Change in lung resistance

    The primary end point is change in lung resistance following a single dose of inhaled b2-AR agonist therapy (albuterol).

    Immediate

Secondary Outcomes (2)

  • Change in lung compliance

    Duration of hospitalization

  • Comparison by genotype

    Duration of Hospitalization

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children hospitalized in the intensive care unit with bronchiolitis

You may qualify if:

  • Admission to the CCMC with a primary admission diagnosis of bronchiolitis.
  • Age between 0 and 2 years.
  • Intubated with cuffed endotracheal tube and mechanically ventilated for less than 72 hours.
  • Receiving inhaled albuterol therapy

You may not qualify if:

  • Congenital Heart Defect
  • Immunodeficiency
  • Pre-existing chronic lung disease, including asthma
  • Receiving additional bronchodilator therapy (such as theophylline or ipratropium) or any therapy that would interfere with measuring pulmonary compliance or resistance
  • Receiving Albuterol more frequently than every 4 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Christopher L Carroll, MD

    Connecticut Children's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 10, 2007

Study Start

December 1, 2007

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

November 30, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)