Testing the Developmental Origins Hypothesis (CHIPS-Child)
CHIPS-Child:Testing the Developmental Origins Hypothesis
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.
Studieoversikt
Detaljert beskrivelse
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).
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Ipswich, Australia
- Rekruttering
- Ipswich Hospital
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Subiaco, Australia
- Rekruttering
- King Edward Memorial Hospital
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Alberta
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Edmonton, Alberta, Canada
- Rekruttering
- Royal Alexandra Hospital
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British Columbia
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Surrey, British Columbia, Canada
- Rekruttering
- Surrey Memorial Hospital: Jim Pttison Outpatient Care & Surgery Centre
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Vancouver, British Columbia, Canada, V6H 3N1
- Rekruttering
- BC Children & Women's Health Centre
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Hovedetterforsker:
- Laura A Magee, MD FRCPC MSc
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Rekruttering
- IWK Health Centre
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Ontario
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London, Ontario, Canada
- Rekruttering
- London Health Sciences Centre
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Sherbrooke, Ontario, Canada
- Rekruttering
- CHUS Fleurimont
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Toronto, Ontario, Canada
- Rekruttering
- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada
- Rekruttering
- Hopital Sainte-Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- Rekruttering
- Royal University Hospital
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Osorno, Chile
- Rekruttering
- Hospital Base Osorno
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Puente Alto, Chile
- Rekruttering
- Hospital Dr Sotero del Rio
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Tartu, Estland
- Rekruttering
- Tartu University Hospital - Women's Clinic
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Connecticut
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New Haven, Connecticut, Forente stater, 06510
- Rekruttering
- Yale-New Haven Hospital
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- Rekruttering
- Norton Hospital Downtown & Suburban
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New Jersey
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Camden, New Jersey, Forente stater, 08103
- Rekruttering
- Copper University Hospital
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Oregon
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Portland, Oregon, Forente stater, 97239
- Rekruttering
- Oregon Health & Science University
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Amsterdam, Nederland
- Rekruttering
- OLVG
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Amsterdam, Nederland
- Rekruttering
- Academic Medical Center
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Amsterdam, Nederland
- Rekruttering
- VU Medical Center
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Groningen, Nederland
- Rekruttering
- UMCG
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Hilversum, Nederland
- Rekruttering
- Tergooiziekenhuizen
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Maastricht, Nederland
- Rekruttering
- MUMC Maastricht
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Nieuwegein, Nederland
- Rekruttering
- St Antonius Ziekenhuis
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Utrecht, Nederland
- Rekruttering
- UMCU
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Utrecht, Nederland
- Rekruttering
- Diakonessen Ziekenhuis
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Veldhoven, Nederland
- Rekruttering
- Maxima Medical Centre
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Zwolle, Nederland
- Rekruttering
- Isala Klinieken Zwolle
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Christchurch, New Zealand
- Rekruttering
- Christchurch Women's Hospital
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Birmingham, Storbritannia
- Rekruttering
- Birmingham Women's Hospital
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Bradford, Storbritannia
- Rekruttering
- Bradford Royal Infirmary
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Lancaster, Storbritannia
- Rekruttering
- Royal Lancaster Infirmary
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Newcastle Upon Tyne, Storbritannia
- Rekruttering
- Royal Victoria Infirmary
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Nottingham, Storbritannia
- Rekruttering
- Nottingham City Hospital
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Ormskirk, Storbritannia
- Rekruttering
- Southport & Ormskirk Hospital
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Plymouth, Storbritannia
- Rekruttering
- Derriford Hospital
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Sunderland, Storbritannia
- Rekruttering
- City Hospitals Sunderland NHS Foundation Trust
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Swansea, Storbritannia
- Rekruttering
- Singleton Hospital
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Wolverhampton, Storbritannia
- Rekruttering
- New Cross Hospital
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York, Storbritannia
- Rekruttering
- York District Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Tight
Children born to women in the CHIPS RCT randomized to "Tight" blood pressure control [target diastolic BP 85mmHg]
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Less Tight
Children born to women in the CHIPS RCT randomized to "Less Tight" [target diastolic BP 100mmHg].
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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difference in 'change in z score for weight' at 12 m(+/- 2m)
Tidsramme: birth to 12m (+/-2m) of age, 24m, 36m, 48m, 60m
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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.
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birth to 12m (+/-2m) of age, 24m, 36m, 48m, 60m
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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hypothalamic pituitary adrenal axis function
Tidsramme: average of 12m (+/-2m) of age
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Hair collected at 12m (+/-2m) of age will be analysed for hypothalamic pituitary adrenal axis function (hair cortisol for overall cortisol production).
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average of 12m (+/-2m) of age
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differences in DNA methylation
Tidsramme: average of 12 m (+/- 2m) of age
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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.
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average of 12 m (+/- 2m) of age
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Laura A Magee, MD, BC Children & Women's Health Centre
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- H08-00882CHIPS-Child
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