Longitudinal Analysis of Spirometry in Black Children
Primary Purpose
Lung Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by

About this trial
This is an observational trial for Lung Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005422
First Posted
May 25, 2000
Last Updated
May 12, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005422
Brief Title
Longitudinal Analysis of Spirometry in Black Children
Study Type
Observational
2. Study Status
Record Verification Date
June 2000
Overall Recruitment Status
Completed
Study Start Date
April 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 1995 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To conduct a longitudinal investigation of early childhood lower respiratory illness (LRI) and patterns of lung growth using an existing electronic dataset generated by an 18-year study (1972-1990) of a population of 102 Black children followed from birth at the Frank Porter Graham Child Development Center.
Detailed Description
BACKGROUND:
The study should improve knowledge of the patterns of functional lung development during childhood and factors that influence both relative level and growth rate of lung function in Black children and should offer new understanding of the predictive value of spirometric tests of lung function performed at an early age.
DESIGN NARRATIVE:
The study used a previously existing database which was of unique value because it included comprehensive respiratory illness data collected on-site during the children's tenure in the Frank Porter Graham Child Development Center's daycare facility and spirometric data collected longitudinally from three to 13 years of age. Furthermore, the measurements were for children in a racial group for whom limited cross-sectional or longitudinal spirometric data were available.
The longitudinal analyses had two primary objectives. The first was to characterize patterns of functional lung development in Black children from three to 13 years of age and relate these patterns to potentially influential factors such as (a) wheezing and non-wheezing associated LRI experience during the infant (ages 0 to two) and preschool (ages two to five) years, (b) ages of occurrence of first and subsequent LRI episodes, and (c) respiratory syncytial virus etiology of LRI. Potentially confounding factors included prenatal and childhood exposure to environmental tobacco smoke and allergies. The second objective was to determine the degree to which spirometric parameters 'track' for individual children and for populations of children over the interval from three to 13 years of age. This objective required assessment of the degree to which spirometric evaluations during the preschool years were predictive of later lung function.
The statistical analyses for achieving these objectives used recently developed statistical methods based on the general linear mixed model. By design, these methods for longitudinal data handled unbalanced data with missing values, incorporated time-varying covariates, and provided more exactly the extent to which the level of lung function of individual children was maintained relative to that of other study children and determined the value of preschool spirometric measurements as predictors of levels of spirometric performance during later childhood and adolescence. These analyses utilized methods developed by Stewart, Pekow, Burchinal, and Helms in 1991 that were unique in that they were designed to handle incomplete, inconsistently-timed data as well as complete, balanced data.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Learn more about this trial
Longitudinal Analysis of Spirometry in Black Children
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