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

About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006322
First Posted
October 2, 2000
Last Updated
March 15, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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
background
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Birth Weight Effect on Blood Pressure in Late Childhood
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