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Birth Weight Effect on Blood Pressure in Late Childhood

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypertension

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

11 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 2, 2000
    Last Updated
    March 15, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006322
    Brief Title
    Birth Weight Effect on Blood Pressure in Late Childhood
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    March 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To investigate the relationship of birth weight and childhood blood pressure.
    Detailed Description
    BACKGROUND: Cardiovascular diseases are the leading causes of morbidity and mortality in the United States. On the basis of an interplay of genetic and environmental factors, these diseases appear to be rooted in childhood. Recent reports implicate the intrauterine nutritional environment regulating fetal growth as a determinant of adult cardiovascular disease. According to this concept, impaired fetal growth, with consequent lower birth weight, results in alteration in organ structure and subsequent functional impairment in later life. Higher blood pressure (BP) has been suggested as the possible link between compromised intrauterine growth and the long-term risk for cardiovascular disease. Despite the many reports which appear to support the low birth weight - high BP hypothesis, this concept is in conflict with the body of data on the association of BP with body size in childhood, adolescence, and adulthood which consistently demonstrates a direct relationship between body weight and BP. The results of this prospective study contributed an objective body of data to this important issue. If birth measures reflecting intrauterine exposure do contribute significantly to BP in later childhood, then studies focused on the mechanisms regulating this risk are justified. Alternatively, if post-natal/childhood parameters are the major determinants of later BP, then efforts should focus on effective preventive strategies in childhood, such as obesity. DESIGN NARRATIVE: To examine the low birth weight - high blood pressure concept, the investigators conducted a prospective study on a cohort of children who were well characterized at birth. In 1988, data on weight, length, BP, gestation and maternal health were obtained on 1,160 newborn cases representing a range of birth weight and gestational age. They re-examined these children at age 11-13 years to test the overall hypothesis that birth weight, as well as other newborn measures of intrauterine growth, did not correlate with BP at age 11-13 years. The aims of the project were to: 1) determine if birth weight contributed to BP and/or body size in childhood; 2) determine if the duration of intrauterine growth in terms of gestational age contributed to BP and body size; 3) determine if newborn ponderal index, a measure of relative fetal growth, contributed to BP and body size; and 4) determine the relative contribution of newborn measures of birth weight, gestational age, BP, ponderal index, and maternal health to BP and body size in late childhood. 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
    Cardiovascular Diseases, Heart Diseases, Hypertension

    7. Study Design

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    14676220
    Citation
    Falkner B, Hulman S, Kushner H. Effect of birth weight on blood pressure and body size in early adolescence. Hypertension. 2004 Feb;43(2):203-7. doi: 10.1161/01.HYP.0000109322.72948.24. Epub 2003 Dec 15.
    Results Reference
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    Birth Weight Effect on Blood Pressure in Late Childhood

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