NCT00831038

Brief Summary

Infants less than 2 years old who have been newly diagnosed with problems swallowing will have pulmonary function tests performed to try to detect the presence of chronic lung disease. Six months later after the infants have received appropriate therapy for their swallowing problems, pulmonary function tests will be performed again to see if there has been any change in their chronic lung disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

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

August 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 30, 2011

Status Verified

November 1, 2011

Enrollment Period

2.8 years

First QC Date

January 27, 2009

Last Update Submit

November 28, 2011

Conditions

Chronic Lung Disease

Keywords

pulmonary function testsinfantschronic lung diseasedysphagiachronic aspiration

Outcome Measures

Primary Outcomes (1)

  • infant pulmonary function test results

    On admission to study and 6 months later

Interventions

Infant Pulmonary Function TestsPROCEDURE

Tests will be performed on study patients within 1 week of study enrollment and again 6 months later.

Eligibility Criteria

Age1 Month - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • infants between ages 1-24 months who have been newly diagnosed with dysphagia

You may not qualify if:

  • cystic fibrosis
  • obstructive sleep apnea
  • seizures
  • allergy or adverse reaction to chloral hydrate
  • heart disease
  • liver disease
  • kidney disease
  • pneumonia
  • pleural effusion
  • neuromuscular disease
  • major congenital anomalies
  • tracheoesophageal fistula
  • vascular ring
  • bronchopulmonary dysplasia
  • pharyngeal anomalies
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LeBonheur Children's Medical Center

Memphis, Tennessee, 38103, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • James D Tutor, MD

    Methodist/LeBonheur Healthcare/University of Tennessee College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
James D. Tutor, M.D.

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

August 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

November 30, 2011

Record last verified: 2011-11

Locations

US(1)