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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Ipswich, Australien
- Rekrutierung
- Ipswich Hospital
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Subiaco, Australien
- Rekrutierung
- King Edward Memorial Hospital
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Osorno, Chile
- Rekrutierung
- Hospital Base Osorno
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Puente Alto, Chile
- Rekrutierung
- Hospital Dr Sotero del Rio
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Tartu, Estland
- Rekrutierung
- Tartu University Hospital - Women's Clinic
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Alberta
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Edmonton, Alberta, Kanada
- Rekrutierung
- Royal Alexandra Hospital
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British Columbia
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Surrey, British Columbia, Kanada
- Rekrutierung
- Surrey Memorial Hospital: Jim Pttison Outpatient Care & Surgery Centre
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Vancouver, British Columbia, Kanada, V6H 3N1
- Rekrutierung
- BC Children & Women's Health Centre
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Hauptermittler:
- Laura A Magee, MD FRCPC MSc
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Nova Scotia
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Halifax, Nova Scotia, Kanada
- Rekrutierung
- IWK Health Centre
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Ontario
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London, Ontario, Kanada
- Rekrutierung
- London Health Sciences Centre
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Sherbrooke, Ontario, Kanada
- Rekrutierung
- CHUS Fleurimont
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Toronto, Ontario, Kanada
- Rekrutierung
- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Kanada
- Rekrutierung
- Hopital Sainte-Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada
- Rekrutierung
- Royal University Hospital
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Christchurch, Neuseeland
- Rekrutierung
- Christchurch Women's Hospital
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Amsterdam, Niederlande
- Rekrutierung
- OLVG
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Amsterdam, Niederlande
- Rekrutierung
- Academic Medical Center
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Amsterdam, Niederlande
- Rekrutierung
- VU Medical Center
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Groningen, Niederlande
- Rekrutierung
- UMCG
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Hilversum, Niederlande
- Rekrutierung
- Tergooiziekenhuizen
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Maastricht, Niederlande
- Rekrutierung
- MUMC Maastricht
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Nieuwegein, Niederlande
- Rekrutierung
- St Antonius Ziekenhuis
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Utrecht, Niederlande
- Rekrutierung
- UMCU
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Utrecht, Niederlande
- Rekrutierung
- Diakonessen Ziekenhuis
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Veldhoven, Niederlande
- Rekrutierung
- Maxima Medical Centre
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Zwolle, Niederlande
- Rekrutierung
- Isala Klinieken Zwolle
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Connecticut
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New Haven, Connecticut, Vereinigte Staaten, 06510
- Rekrutierung
- Yale-New Haven Hospital
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Kentucky
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Louisville, Kentucky, Vereinigte Staaten, 40202
- Rekrutierung
- Norton Hospital Downtown & Suburban
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New Jersey
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Camden, New Jersey, Vereinigte Staaten, 08103
- Rekrutierung
- Copper University Hospital
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Oregon
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Portland, Oregon, Vereinigte Staaten, 97239
- Rekrutierung
- Oregon Health & Science University
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Birmingham, Vereinigtes Königreich
- Rekrutierung
- Birmingham Women's Hospital
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Bradford, Vereinigtes Königreich
- Rekrutierung
- Bradford Royal Infirmary
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Lancaster, Vereinigtes Königreich
- Rekrutierung
- Royal Lancaster Infirmary
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Newcastle Upon Tyne, Vereinigtes Königreich
- Rekrutierung
- Royal Victoria Infirmary
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Nottingham, Vereinigtes Königreich
- Rekrutierung
- Nottingham City Hospital
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Ormskirk, Vereinigtes Königreich
- Rekrutierung
- Southport & Ormskirk Hospital
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Plymouth, Vereinigtes Königreich
- Rekrutierung
- Derriford Hospital
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Sunderland, Vereinigtes Königreich
- Rekrutierung
- City Hospitals Sunderland NHS Foundation Trust
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Swansea, Vereinigtes Königreich
- Rekrutierung
- Singleton Hospital
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Wolverhampton, Vereinigtes Königreich
- Rekrutierung
- New Cross Hospital
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York, Vereinigtes Königreich
- Rekrutierung
- York District Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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difference in 'change in z score for weight' at 12 m(+/- 2m)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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hypothalamic pituitary adrenal axis function
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Laura A Magee, MD, BC Children & Women's Health Centre
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- H08-00882CHIPS-Child
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