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.
Panoramica dello studio
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Ipswich, Australia
- Reclutamento
- Ipswich Hospital
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Subiaco, Australia
- Reclutamento
- King Edward Memorial Hospital
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Alberta
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Edmonton, Alberta, Canada
- Reclutamento
- Royal Alexandra Hospital
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British Columbia
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Surrey, British Columbia, Canada
- Reclutamento
- Surrey Memorial Hospital: Jim Pttison Outpatient Care & Surgery Centre
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Vancouver, British Columbia, Canada, V6H 3N1
- Reclutamento
- BC Children & Women's Health Centre
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Investigatore principale:
- Laura A Magee, MD FRCPC MSc
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Reclutamento
- IWK Health Centre
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Ontario
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London, Ontario, Canada
- Reclutamento
- London Health Sciences Centre
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Sherbrooke, Ontario, Canada
- Reclutamento
- CHUS Fleurimont
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Toronto, Ontario, Canada
- Reclutamento
- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada
- Reclutamento
- Hopital Sainte-Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- Reclutamento
- Royal University Hospital
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Osorno, Chile
- Reclutamento
- Hospital Base Osorno
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Puente Alto, Chile
- Reclutamento
- Hospital Dr Sotero del Rio
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Tartu, Estonia
- Reclutamento
- Tartu University Hospital - Women's Clinic
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Christchurch, Nuova Zelanda
- Reclutamento
- Christchurch Women's Hospital
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Amsterdam, Olanda
- Reclutamento
- OLVG
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Amsterdam, Olanda
- Reclutamento
- Academic Medical Center
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Amsterdam, Olanda
- Reclutamento
- VU Medical Center
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Groningen, Olanda
- Reclutamento
- UMCG
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Hilversum, Olanda
- Reclutamento
- Tergooiziekenhuizen
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Maastricht, Olanda
- Reclutamento
- MUMC Maastricht
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Nieuwegein, Olanda
- Reclutamento
- St Antonius Ziekenhuis
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Utrecht, Olanda
- Reclutamento
- UMCU
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Utrecht, Olanda
- Reclutamento
- Diakonessen Ziekenhuis
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Veldhoven, Olanda
- Reclutamento
- Maxima Medical Centre
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Zwolle, Olanda
- Reclutamento
- Isala Klinieken Zwolle
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Birmingham, Regno Unito
- Reclutamento
- Birmingham Women's Hospital
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Bradford, Regno Unito
- Reclutamento
- Bradford Royal Infirmary
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Lancaster, Regno Unito
- Reclutamento
- Royal Lancaster Infirmary
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Newcastle Upon Tyne, Regno Unito
- Reclutamento
- Royal Victoria Infirmary
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Nottingham, Regno Unito
- Reclutamento
- Nottingham City Hospital
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Ormskirk, Regno Unito
- Reclutamento
- Southport & Ormskirk Hospital
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Plymouth, Regno Unito
- Reclutamento
- Derriford Hospital
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Sunderland, Regno Unito
- Reclutamento
- City Hospitals Sunderland NHS Foundation Trust
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Swansea, Regno Unito
- Reclutamento
- Singleton Hospital
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Wolverhampton, Regno Unito
- Reclutamento
- New Cross Hospital
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York, Regno Unito
- Reclutamento
- York District Hospital
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06510
- Reclutamento
- Yale-New Haven Hospital
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40202
- Reclutamento
- Norton Hospital Downtown & Suburban
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New Jersey
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Camden, New Jersey, Stati Uniti, 08103
- Reclutamento
- Copper University Hospital
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Oregon
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Portland, Oregon, Stati Uniti, 97239
- Reclutamento
- Oregon Health & Science University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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difference in 'change in z score for weight' at 12 m(+/- 2m)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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hypothalamic pituitary adrenal axis function
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Laura A Magee, MD, BC Children & Women's Health Centre
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- H08-00882CHIPS-Child
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