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Lung DiseasesNCT00005422

Longitudinal Analysis of Spirometry in Black Children

An observational study of Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 100 years, men only
Conditions the study is for
Lung Diseases
How many people
Not given
Where
No sites listed yet
Study dates
Apr 1992to Mar 1995
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 100 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

No eligibility criteria

About this study

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.

Read the 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.

Conditions
Lung Diseases
Medical subject headings
Lung Diseases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startApr 1992
  3. Study completionMar 1995

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005422
Sponsor's protocol ID
4340
Other IDs
R03HL048400
Status last verified
Jun 2000
First submitted
25 May 2000
Last updated
13 May 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.

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