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.
調査の概要
詳細な説明
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).
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Connecticut
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New Haven、Connecticut、アメリカ、06510
- 募集
- Yale-New Haven Hospital
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Kentucky
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Louisville、Kentucky、アメリカ、40202
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- Norton Hospital Downtown & Suburban
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New Jersey
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Camden、New Jersey、アメリカ、08103
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- Copper University Hospital
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Oregon
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Portland、Oregon、アメリカ、97239
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- Oregon Health & Science University
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Birmingham、イギリス
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- Birmingham Women's Hospital
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Bradford、イギリス
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- Bradford Royal Infirmary
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Lancaster、イギリス
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- Royal Lancaster Infirmary
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Newcastle Upon Tyne、イギリス
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- Royal Victoria Infirmary
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Nottingham、イギリス
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- Nottingham City Hospital
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Ormskirk、イギリス
- 募集
- Southport & Ormskirk Hospital
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Plymouth、イギリス
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- Derriford Hospital
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Sunderland、イギリス
- 募集
- City Hospitals Sunderland NHS Foundation Trust
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Swansea、イギリス
- 募集
- Singleton Hospital
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Wolverhampton、イギリス
- 募集
- New Cross Hospital
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York、イギリス
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- York District Hospital
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Tartu、エストニア
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- Tartu University Hospital - Women's Clinic
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Amsterdam、オランダ
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- OLVG
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Amsterdam、オランダ
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- Academic Medical Center
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Amsterdam、オランダ
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- VU Medical Center
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Groningen、オランダ
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- UMCG
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Hilversum、オランダ
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- Tergooiziekenhuizen
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Maastricht、オランダ
- 募集
- MUMC Maastricht
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Nieuwegein、オランダ
- 募集
- St Antonius Ziekenhuis
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Utrecht、オランダ
- 募集
- UMCU
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Utrecht、オランダ
- 募集
- Diakonessen Ziekenhuis
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Veldhoven、オランダ
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- Maxima Medical Centre
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Zwolle、オランダ
- 募集
- Isala Klinieken Zwolle
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Ipswich、オーストラリア
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- Ipswich Hospital
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Subiaco、オーストラリア
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- King Edward Memorial Hospital
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Alberta
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Edmonton、Alberta、カナダ
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- Royal Alexandra Hospital
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British Columbia
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Surrey、British Columbia、カナダ
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- Surrey Memorial Hospital: Jim Pttison Outpatient Care & Surgery Centre
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Vancouver、British Columbia、カナダ、V6H 3N1
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- BC Children & Women's Health Centre
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主任研究者：
- Laura A Magee, MD FRCPC MSc
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Nova Scotia
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Halifax、Nova Scotia、カナダ
- 募集
- IWK Health Centre
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Ontario
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London、Ontario、カナダ
- 募集
- London Health Sciences Centre
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Sherbrooke、Ontario、カナダ
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- CHUS Fleurimont
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Toronto、Ontario、カナダ
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- Sunnybrook Health Sciences Centre
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Quebec
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Montreal、Quebec、カナダ
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- Hopital Sainte-Justine
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Saskatchewan
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Saskatoon、Saskatchewan、カナダ
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- Royal University Hospital
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Osorno、チリ
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- Hospital Base Osorno
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Puente Alto、チリ
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- Hospital Dr Sotero del Rio
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Christchurch、ニュージーランド
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- Christchurch Women's Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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difference in 'change in z score for weight' at 12 m(+/- 2m)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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hypothalamic pituitary adrenal axis function
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Laura A Magee, MD、BC Children & Women's Health Centre
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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