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Testing the Developmental Origins Hypothesis (CHIPS-Child)

This study is currently recruiting participants.
Verified March 2012 by Laura Magee, Children's & Women's Health Centre of British Columbia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01545492
First Posted: March 6, 2012
Last Update Posted: March 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Laura Magee, Children's & Women's Health Centre of British Columbia
  Purpose

INTRODUCTION: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled trial (RCT). CHIPS is designed to determine whether 'less tight' control [target diastolic BP (dBP) 100mmHg] or 'tight' control [target dBP 85mmHg] of non-proteinuric hypertension in pregnancy is better for the baby without increasing maternal risk.

CHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to non-invasive examination [anthropometry, hair cortisol, buccal swabs for epigenetic testing and a maternal questionnaire about infant feeding practices and background]. Annual contact will be maintained in years 2-5 and contact will include annual parental measurement of the child's height, weight and waist circumference.

OBJECTIVE: To directly test, for the first time in humans, whether differential blood pressure (BP) control in pregnancy has developmental programming effects, independent of birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less tight') control of maternal BP will be associated with fetal under-nutrition and effects will be consistent with developmental programming.


Condition
Diabetes Stroke Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CHIPS-Child:Testing the Developmental Origins Hypothesis

Further study details as provided by Laura Magee, Children's & Women's Health Centre of British Columbia:

Primary Outcome Measures:
  • difference in 'change in z score for weight' at 12 m(+/- 2m) [ Time Frame: birth to 12m (+/-2m) of age, 24m, 36m, 48m, 60m ]
    Between-group difference in early postnatal weight gain ('change in z score for weight') between birth and 12 m (p<0.05), 24m, 36m, 48m & 60m.


Secondary Outcome Measures:
  • hypothalamic pituitary adrenal axis function [ Time Frame: average of 12m (+/-2m) of age ]
    Hair collected at 12m (+/-2m) of age will be analysed for hypothalamic pituitary adrenal axis function (hair cortisol for overall cortisol production).

  • differences in DNA methylation [ Time Frame: average of 12 m (+/- 2m) of age ]
    Buccal swab samples collected at 12m (+/-2m) of age will be assessed for between-groups differences in DNA methylation, using targeted (genes associated with growth, obesity, cardiovascular disease, and/or a developmental programming effect) and global (genome-wide microarray) methods.


Biospecimen Retention:   Samples With DNA
  1. ~150 strands of hair
  2. Four buccal swabs

Estimated Enrollment: 626
Study Start Date: January 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tight
Children born to women in the CHIPS RCT randomized to "Tight" blood pressure control [target diastolic BP 85mmHg]
Less Tight
Children born to women in the CHIPS RCT randomized to "Less Tight" [target diastolic BP 100mmHg].

Detailed Description:

INTRODUCTION: Growing evidence shows that reduced fetal growth rate is associated with adult cardiovascular risk markers (e.g., obesity) and disease, and evidence worldwide indicates that this relationship is independent of birthweight. The leading theory describes 'developmental programming' in utero leading to permanent alteration of the fetal genome. While those changes are adaptive in utero, they may be maladaptive postnatally.

OBJECTIVE: To directly test, for the first time in humans, whether differential blood pressure (BP) control in pregnancy has developmental programming effects, independent of birthweight. We predict that, like famine or protein malnutrition, 'tight' (vs. 'less tight') control of maternal BP will be associated with fetal under-nutrition and effects will be consistent with developmental programming.

METHODS: CHIPS-Child is a parallel, ancillary study to the CHIPS randomized controlled trial (RCT). CHIPS is designed to determine whether 'less tight' control [target diastolic BP (dBP) 100mmHg] or 'tight' control [target dBP 85mmHg] of non-proteinuric hypertension in pregnancy is better for the baby without increasing maternal risk.

CHIPS-Child is a follow up study at 12 m corrected post-gestational age (± 2 m) limited to non-invasive examination [anthropometry, hair cortisol, buccal swabs for epigenetic testing and a maternal questionnaire about infant feeding practices and background]. Annual contact will be maintained in years 2-5 and contact will include annual parental measurement of the child's height, weight and waist circumference.

Sample size:. CHIPS will recruit 1028 women. We estimate that 80% of CHIPS centres will participate in CHIPS-Child, approximately 97% of babies will survive, and 90% of children will be followed to 12 m resulting in a sample size of 626. Power will be >80% to detect a between-group difference of ≥0.25 in 'change in z-score for weight' between birth and 12 m (2-sided alpha=0.05, SD 1).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Only women participating in the CHIPS RCT and their children born after recruitment are eligible to participate in CHIPS-Child.
Criteria

Inclusion Criteria:

  • All women participating in CHIPS and their children born after recruitment.

Exclusion Criteria:

  • Women who have experienced the loss of their pregnancy or child after recruitment into CHIPS.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545492


Contacts
Contact: Kristal T Louie, MS 604.875.2424 ext 5321 CHIPS-Child@cw.bc.ca

  Show 41 Study Locations
Sponsors and Collaborators
Children's & Women's Health Centre of British Columbia
Investigators
Principal Investigator: Laura A Magee, MD BC Children & Women's Health Centre
  More Information

Publications:
Responsible Party: Laura Magee, Clinical Professor of Medicine, Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier: NCT01545492     History of Changes
Other Study ID Numbers: H08-00882CHIPS-Child
First Submitted: February 24, 2012
First Posted: March 6, 2012
Last Update Posted: March 6, 2012
Last Verified: March 2012

Keywords provided by Laura Magee, Children's & Women's Health Centre of British Columbia:
CHIPS
famine
reprogramming
developmental
blood
pressure
randomised
randomized
hypertension
anthropometry
measurement
genetics
epigenetics
methylation
cortisol
stress
DNA
growth
weight
length
height