Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis

NCT00006273 | Unknown

• 2 other identifiers: NCRR-M01RR00750-9040IU-9509-20
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES: I. Compare the resting energy expenditure using respiratory calorimetry in infants and children with moderate to severe cystic fibrosis versus age matched healthy controls. II. Determine the total energy expenditure and energy spent on physical activity using the doubly labeled water method in these patient populations.

Conditions

Cystic Fibrosis

Keywords

cardiovascular and respiratory diseases; cystic fibrosis; genetic diseases and dysmorphic syndromes; rare disease

Eligibility Criteria

• Age: 0 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Diagnosis of cystic fibrosis (CF) by two positive sweat tests No exacerbations of present condition within past 2 months FEV1 less than 50% of predicted No other uncorrected lung disease No requirement for supplemental oxygen OR * Healthy (control group) Age matched to CF patients No preexisting lung disease Clinically well No hospitalizations within past 6 months --Prior/Concurrent Therapy-- * Concurrent pancreatic enzyme supplementation for CF required Clinically stable on current medications (CF patients) --Patient Characteristics-- * Age: Birth to 12 months 6 to 10 years * Cardiovascular: No major cardiovascular problems (CF patients) No preexisting heart disease (control group) * Pulmonary: See Disease Characteristics * Other: No chromosomal abnormalities (CF patients) No acute infection (CF patients) No diabetes mellitus (both groups)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• Indiana University School of Medicine: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202-5167, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Respiratory Tract Diseases; Genetic Diseases, Inborn; Rare Diseases

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine A. Leitch

  Indiana University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: NATURAL HISTORY
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: September 12, 2000
• Study Start: June 1, 1996
• Last Updated: June 24, 2005

Record last verified: 2003-12

Locations

US (1)