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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | April 1992 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005422 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Longitudinal Analysis of Spirometry in Black Children |
| Official Title ICMJE | |
| 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. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Natural History |
| Condition ICMJE | Lung Diseases |
| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | March 1995 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00005422 |
| Responsible Party | |
| Study ID Numbers ICMJE | 4340 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | June 2000 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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