Testing the Developmental Origins Hypothesis

NCT01545492 | Unknown DMC

• 1 other identifier: H08-00882CHIPS-Child
• Study Type: observational
• Target: 626
• Locations: 8 countries
• Sites: 41

Brief Summary

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.

Conditions

Diabetes; Stroke; Obesity

Keywords

CHIPS; famine; reprogramming; developmental; blood; pressure; randomised; randomized; hypertension; anthropometry; measurement; genetics; epigenetics; methylation; cortisol; stress; DNA; growth; weight; length; height

Outcome Measures

Primary Outcomes (1)

• difference in 'change in z score for weight' at 12 m(+/- 2m)

  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.

  birth to 12m (+/-2m) of age, 24m, 36m, 48m, 60m

Secondary Outcomes (2)

• hypothalamic pituitary adrenal axis function

  average of 12m (+/-2m) of age

• differences in DNA methylation

  average of 12 m (+/- 2m) of age

Study Arms (2)

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" \[target diastolic BP 100mmHg\].

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Women who have experienced the loss of their pregnancy or child after recruitment into CHIPS.

Sponsors & Collaborators

• Children's & Women's Health Centre of British Columbia: lead

Study Sites (41)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Norton Hospital Downtown & Suburban

Louisville, Kentucky, 40202, United States

RECRUITING

Copper University Hospital

Camden, New Jersey, 08103, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Ipswich Hospital

Ipswich, Australia

RECRUITING

King Edward Memorial Hospital

Subiaco, Australia

RECRUITING

Royal Alexandra Hospital

Edmonton, Alberta, Canada

RECRUITING

Surrey Memorial Hospital: Jim Pttison Outpatient Care & Surgery Centre

Surrey, British Columbia, Canada

RECRUITING

BC Children & Women's Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

IWK Health Centre

Halifax, Nova Scotia, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, Canada

RECRUITING

CHUS Fleurimont

Sherbrooke, Ontario, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

RECRUITING

Hopital Sainte-Justine

Montreal, Quebec, Canada

RECRUITING

Royal University Hospital

Saskatoon, Saskatchewan, Canada

RECRUITING

Hospital Base Osorno

Osorno, Chile

RECRUITING

Hospital Dr Sotero del Rio

Puente Alto, Chile

RECRUITING

Tartu University Hospital - Women's Clinic

Tartu, Estonia

RECRUITING

Academic Medical Center

Amsterdam, Netherlands

RECRUITING

OLVG

Amsterdam, Netherlands

RECRUITING

VU Medical Center

Amsterdam, Netherlands

RECRUITING

UMCG

Groningen, Netherlands

RECRUITING

Tergooiziekenhuizen

Hilversum, Netherlands

RECRUITING

MUMC Maastricht

Maastricht, Netherlands

RECRUITING

St Antonius Ziekenhuis

Nieuwegein, Netherlands

RECRUITING

Diakonessen Ziekenhuis

Utrecht, Netherlands

RECRUITING

UMCU

Utrecht, Netherlands

RECRUITING

Maxima Medical Centre

Veldhoven, Netherlands

RECRUITING

Isala Klinieken Zwolle

Zwolle, Netherlands

RECRUITING

Christchurch Women's Hospital

Christchurch, New Zealand

RECRUITING

Birmingham Women's Hospital

Birmingham, United Kingdom

RECRUITING

Bradford Royal Infirmary

Bradford, United Kingdom

RECRUITING

Royal Lancaster Infirmary

Lancaster, United Kingdom

RECRUITING

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

RECRUITING

Nottingham City Hospital

Nottingham, United Kingdom

RECRUITING

Southport & Ormskirk Hospital

Ormskirk, United Kingdom

RECRUITING

Derriford Hospital

Plymouth, United Kingdom

RECRUITING

City Hospitals Sunderland NHS Foundation Trust

Sunderland, United Kingdom

RECRUITING

Singleton Hospital

Swansea, United Kingdom

RECRUITING

New Cross Hospital

Wolverhampton, United Kingdom

RECRUITING

York District Hospital

York, United Kingdom

RECRUITING

Related Publications (7)

• Wadhwa PD, Buss C, Entringer S, Swanson JM. Developmental origins of health and disease: brief history of the approach and current focus on epigenetic mechanisms. Semin Reprod Med. 2009 Sep;27(5):358-68. doi: 10.1055/s-0029-1237424. Epub 2009 Aug 26.

  PMID: 19711246 BACKGROUND

• Waterland RA, Michels KB. Epigenetic epidemiology of the developmental origins hypothesis. Annu Rev Nutr. 2007;27:363-88. doi: 10.1146/annurev.nutr.27.061406.093705.

  PMID: 17465856 BACKGROUND

• Gilbert EF, Varakis J, Opitz JM, ZuRhein GM, Ware R, Viseskul C, Kaveggia EG, Hartmann HA. Generalized gangliosidosis type II (juvenile GM1 gangliosidosis). A pathological, histochemical and ultrastructural study. Z Kinderheilkd. 1975 Sep 11;120(3):151-80. doi: 10.1007/BF00439006.

  PMID: 126533 BACKGROUND

• Painter RC, Roseboom TJ, Bleker OP. Prenatal exposure to the Dutch famine and disease in later life: an overview. Reprod Toxicol. 2005 Sep-Oct;20(3):345-52. doi: 10.1016/j.reprotox.2005.04.005.

  PMID: 15893910 BACKGROUND

• Tobi EW, Lumey LH, Talens RP, Kremer D, Putter H, Stein AD, Slagboom PE, Heijmans BT. DNA methylation differences after exposure to prenatal famine are common and timing- and sex-specific. Hum Mol Genet. 2009 Nov 1;18(21):4046-53. doi: 10.1093/hmg/ddp353. Epub 2009 Aug 4.

  PMID: 19656776 BACKGROUND

• Silveira PP, Portella AK, Goldani MZ, Barbieri MA. Developmental origins of health and disease (DOHaD). J Pediatr (Rio J). 2007 Nov-Dec;83(6):494-504. doi: 10.2223/JPED.1728.

  PMID: 18074050 BACKGROUND

• Cameron N, Demerath EW. Critical periods in human growth and their relationship to diseases of aging. Am J Phys Anthropol. 2002;Suppl 35:159-84. doi: 10.1002/ajpa.10183.

  PMID: 12653312 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. \~150 strands of hair 2. Four buccal swabs

MeSH Terms

Conditions

Diabetes Mellitus; Stroke; Obesity; Hypertension; Body Weight

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura A Magee, MD

  BC Children & Women's Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristal T Louie, MS

CONTACT

604.875.2424; CHIPS-Child@cw.bc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 6, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: March 6, 2012

Record last verified: 2012-03

Locations

GB (11); AU (2); US (4); CA (9); CL (2); ES (1); NL (11); NZ (1)