Cardiovascular DiseasesNCT00006322
Birth Weight Effect on Blood Pressure in Late Childhood
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate the relationship of birth weight and childhood blood pressure. Read more about this study
- Who is it for?
- Ages 11 to 13 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1999to Jun 2003
- 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 11 to 13 years
- All sexes
- No healthy volunteers
- Child
No eligibility criteria
About this study
To investigate the relationship of birth weight and childhood blood pressure.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2000 (estimated)
- Study startJul 1999
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006322
- Sponsor's protocol ID
- 925
- Other IDs
- R01HL060858
- Status last verified
- Mar 2005
- First submitted
- 2 Oct 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
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.
PubMed 14676220
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Birth Weight Effect on Blood Pressure in Late Childhood
- ClinicalTrials.gov ID
- NCT00006322
- Acronym / sponsor ID
- 925
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1999
- Study completion
- Jun 2003 (actual)
- First posted
- 3 Oct 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 14676220Falkner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart 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 16 Mar 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?
On the ClinicalTrials.gov record for NCT00006322, which also lists 1 linked publication.
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 16 Mar 2016.