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.
Descripción general del estudio
Descripción detallada
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 de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kristal T Louie, MS
- Número de teléfono: 5321 604.875.2424
- Correo electrónico: CHIPS-Child@cw.bc.ca
Ubicaciones de estudio
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Ipswich, Australia
- Reclutamiento
- Ipswich Hospital
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Subiaco, Australia
- Reclutamiento
- King Edward Memorial Hospital
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Alberta
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Edmonton, Alberta, Canadá
- Reclutamiento
- Royal Alexandra Hospital
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British Columbia
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Surrey, British Columbia, Canadá
- Reclutamiento
- Surrey Memorial Hospital: Jim Pttison Outpatient Care & Surgery Centre
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Vancouver, British Columbia, Canadá, V6H 3N1
- Reclutamiento
- BC Children & Women's Health Centre
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Investigador principal:
- Laura A Magee, MD FRCPC MSc
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Nova Scotia
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Halifax, Nova Scotia, Canadá
- Reclutamiento
- IWK Health Centre
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Ontario
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London, Ontario, Canadá
- Reclutamiento
- London Health Sciences Centre
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Sherbrooke, Ontario, Canadá
- Reclutamiento
- CHUS Fleurimont
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Toronto, Ontario, Canadá
- Reclutamiento
- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canadá
- Reclutamiento
- Hopital Sainte-Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá
- Reclutamiento
- Royal University Hospital
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Osorno, Chile
- Reclutamiento
- Hospital Base Osorno
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Puente Alto, Chile
- Reclutamiento
- Hospital Dr Sotero del Rio
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Reclutamiento
- Yale-New Haven Hospital
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- Reclutamiento
- Norton Hospital Downtown & Suburban
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New Jersey
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Camden, New Jersey, Estados Unidos, 08103
- Reclutamiento
- Copper University Hospital
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Reclutamiento
- Oregon Health & Science University
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Tartu, Estonia
- Reclutamiento
- Tartu University Hospital - Women's Clinic
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Christchurch, Nueva Zelanda
- Reclutamiento
- Christchurch Women's Hospital
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Amsterdam, Países Bajos
- Reclutamiento
- OLVG
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Amsterdam, Países Bajos
- Reclutamiento
- Academic Medical Center
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Amsterdam, Países Bajos
- Reclutamiento
- VU Medical Center
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Groningen, Países Bajos
- Reclutamiento
- UMCG
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Hilversum, Países Bajos
- Reclutamiento
- Tergooiziekenhuizen
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Maastricht, Países Bajos
- Reclutamiento
- MUMC Maastricht
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Nieuwegein, Países Bajos
- Reclutamiento
- St Antonius Ziekenhuis
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Utrecht, Países Bajos
- Reclutamiento
- UMCU
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Utrecht, Países Bajos
- Reclutamiento
- Diakonessen Ziekenhuis
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Veldhoven, Países Bajos
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- Maxima Medical Centre
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Zwolle, Países Bajos
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- Isala Klinieken Zwolle
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Birmingham, Reino Unido
- Reclutamiento
- Birmingham Women's Hospital
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Bradford, Reino Unido
- Reclutamiento
- Bradford Royal Infirmary
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Lancaster, Reino Unido
- Reclutamiento
- Royal Lancaster Infirmary
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Newcastle Upon Tyne, Reino Unido
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- Royal Victoria Infirmary
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Nottingham, Reino Unido
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- Nottingham City Hospital
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Ormskirk, Reino Unido
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- Southport & Ormskirk Hospital
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Plymouth, Reino Unido
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- Derriford Hospital
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Sunderland, Reino Unido
- Reclutamiento
- City Hospitals Sunderland NHS Foundation Trust
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Swansea, Reino Unido
- Reclutamiento
- Singleton Hospital
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Wolverhampton, Reino Unido
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- New Cross Hospital
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York, Reino Unido
- Reclutamiento
- York District Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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difference in 'change in z score for weight' at 12 m(+/- 2m)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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hypothalamic pituitary adrenal axis function
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Investigadores
- Investigador principal: Laura A Magee, MD, BC Children & Women's Health Centre
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- H08-00882CHIPS-Child
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