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Recruiting NCT04017286

Relationship About Pregnancy Health and Offspring Developmental &Behavioral Outcomes

Observational Children Behavior Problem Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Children Behavior Problem, Pregnancy. Basic parameters: 3 months — 72 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Cohort Study of the Association Between Pregnancy Health and Offspring Developmental & Behavioral Outcomes(Multi-Centered)

Overview

This topic puts forward a hypothesis: genetic and environmental factors such as major depressive disorder during pregnancy, nutritional status of vitamin A, D, E, and folic acid, intestinal microecology, and bisphenol A exposure, may affect the cognitive development level of the offspring through the genetic correlation with attention deficit hyperactivity disorder, developmental delay/intellectual disability, and major depressive disorder, allelic heterogeneity and pleiotropy of ITIH3 mediated by SNP and CACNB2, neurotransmitters like dopamine, and metabolic pathways, thereby increasing the risk of attention deficit hyperactivity disorder and developmental delay/intellectual disability prevalence on offspring. This topic planning from allelic heterogeneity and pleiotropy of attention deficit hyperactivity disorder and major depressive disorder mediated by SNP, neurotransmitters like dopamine, and metabolic pathways, explores deeply the influences on children's development level and the risk of common neurological disorder caused by genetic and environmental factors during pregnancy, looking for reasonable prevention, early diagnosis of biomarkers and therapeutic targets, in order to provide data support for further improvement and revision of national mother and infant healthcare policy .

Detailed description

1. Technology Roadmap:①Pregnant Women:Subjects are rolled in the group. ② 21 Weeks of Gestation:Sign informed contents (mother version), test depression scale ( BDI+HAMD ), fill in the basic information questionnaire and collect 3 ml of blood of pregnant women for genetic information extraction. ③Delivery: Sign informed contents(children version), collect 1 ml of umbilical cord blood and 2ml of urine from mother. ④Physical measurements are respectively taken when a child is 3, 6, 12, 24 months old and 3, 6 years old. And the Montreal Children Hospital Feeding Scale will be also respectively completed when a child is 6 and 12 months old. What's more, the investigators plan to carry out developmental screening for the children aged 1, 2, 3 and 6, and if the developmental screening is positive, a diagnostic test then will be carried out. ⑤When children are aged 2, 3 and 6, blood samples are taken from 3 milliliters and urine from 2 milliliters, and nutrients are detected to obtain genetic information. ⑥All biological specimens will be tested for nutrient levels and some other.⑦At last, data analysis is performed on all collected information including physical measurements, feeding behavior questionnaire, all biological specimens and so on. 2. Study Protocol: A. Human Subjects Review: Studies must have approval (or be exempt, as appropriate) from a Human Subjects Protection Review Board prior to the enrollment of the first participant to be eligible for registration (Submitted, approved).

B. Register a clinical study: Prior to the launch of the project, pre-registration will be completed at clinicaltrials.gov in the international clinical study register authority.

C. Study cohort: Screening qualified pregnant women volunteered to take part in the study from pregnancy clinics of Chongqing suburban maternity and child health hospital and The Maternal and Child Health Hospital of Hainan Province. 3. Measuring scale: To assess the depression status and degree of the subjects by Hamilton Depression Scale (HAMD) and Beck depression rating scale (BDI); To evaluate the cognitive function of subjects and exclude the patients with mental retardation by Mini-Mental State Examination (MMSE) and Activity of Daily Living Scale(ADL); To screen or identify the cognitive function and level of children in different age groups by Denver development screening scale (DDST) and Gesell Developmental Schedules (Gesell), and combining with the Adaptive Scale of Infant and Children (SM) to assist in the diagnosis of developmental delay/intellectual disability, The Vanderbilt ADHD Diagnostic Rating Scale on diagnosis of ADHD. 4. Data management and statistical analysis plan:

A. All the data is recorded by the professional staff, and checked by a third person to ensure accuracy of data entry; B. All statistical analysis is performed with SAS 9.4. The statistical analysis is completed by the applicant and the professional statisticians in the epidemiology research office of the unit. 5. Recruitment process:

A. To preach related knowledge of major depressive disorder, ADHD, and developmental delay/intellectual disability in the form of obstetrics clinics, network media, and network health management platform,etc; B. Recruitment information is released by platforms such as obstetrics clinics, network health management platforms, etc., to recruit pregnant women; C. The obstetric nurses and professional recruiters (postgraduate students) assist pregnant women to sign informed consents, agree to participate in the study, and promise that the delivery of children would take part in the same sequence of study as well. 6. The required materials of recruitment:

Manufacture recruiting advertisements of major depressive disorder, ADHD, developmental delay/intellectual disability related knowledge and disease hazards, the importance of early diagnosis, recruitment information of pregnant women and their children enrolled in the study (for example: network media recruitment advertisement, WeChat H5 recruitment advertisement, network health management platform recruitment advertisement, etc.). 7. Benefit Assessment: A. The pregnant women volunteered to participate in the study are able to enjoy regular check-ups (once every three months, including height, weight, blood pressure, mood questionnaires, etc.); B. Eligible children volunteer to participate in the study, all can enjoy free physical examination (height, weight) at the age of 1, 2, 3, and 6, moreover according to age to enjoy free screening or diagnostic test related to cognitive development level and attention deficit hyperactivity disorder test; C. The parents of all the children involved can receive the knowledge of parenting through WeChat or network health management platform, and be provided with free parenting seminars regularly; D. High-risk pregnant women and children are given priority access to the superior hospital for diagnosis and treatment; E. All subjects are eligible for the the nutrient level test of preferential price, 16S test (intestinal flora detection) of the preferential price , free related genetic test; F. Study may solve some urgent problems in the prevention and treatment of developmental disabilities such as ADHD, developmental delay/intellectual disability, and contribute to promoting maternal and child health, improving the quality of the population, and promoting the sustained and healthy development of the national economy. 8. Risk Assessment ( illustrate the possible risk rate and take measures to ensure that risk is minimized in a possible range):

A. Possible risk: the probability of subjects losing to follow-up (loss ratio of 5 to 10% due to various reasons); B. Measurements: The professional staff would regularly contact with the mother or the child by phone or Wechat. And after the birth of a child, childbearing knowledge or childcare lectures are regularly provided for the parents. 9. Special crowd protection:

A.In the course of the study, obstetricians, psychologists, and childcare doctors are all involved in providing health care for pregnant women, mothers and children.

B. At the same time, please protect the subjects' privacy and not to give out the information of the subjects. All subjects' personal information is treated with confidentiality and this study data is only used in the study design scope to ensure that the subjects' privacy is not invaded.

Primary outcome measures

  • Changes in Denver Developmental Screening Test results within 72 months of age [Time frame: 72 months]
  • Changes in Gesell Developmental Schedules test results within 72 months of age [Time frame: 72 months]
  • The Vanderbilt Attention Deficit Hyperactivity Disorder Diagnostic Rating Scale [Time frame: 72 months]
  • Changes in vitamin A [Time frame: 72 months]
  • Changes in Vitamin D [Time frame: 72 months]
  • Changes in Vitamin E [Time frame: 72 months]
  • Homocysteine [Time frame: delivery]
  • Bisphenol A [Time frame: 72 months]
  • the Adaptive Scale of Infant and Children [Time frame: 72 months]
Secondary outcome measures (10)
  • Beck depression rating scale [Time frame: 21 weeks of pregnancy]
  • Hamilton Depression Scale [Time frame: 21 weeks of pregnancy]
  • Mini-Mental State Examination [Time frame: 21 weeks of pregnancy]
  • Changes in the Montreal Children Hospital Feeding Scale within 12 months of age [Time frame: 12 months]
  • Change of weight for height Z-score(WHZ) [Time frame: 72 months]
  • Change of the height for age Z-score(HAZ) [Time frame: 72 months]
  • Change of the weight for Age Z-score(WAZ) [Time frame: 72 months]
  • Ferritin [Time frame: 24 months]
  • Folate [Time frame: 24 months]
  • Activity of Daily Living Scale [Time frame: 21 weeks of pregnancy]

Eligibility criteria

Inclusion criteria

  • Inclusion criteria for pregnant women: Aged 20\~49;
  • no cognitive impairment, able to complete the scale test;
  • Hamilton Depression Scale (HAMD questionnaire) is normal (HAMD score <8 points) or mild to moderate positive (HAMD questionnaire score: 8\~35 points);
  • Participants are asked for their own written informed content for the study;

Exclusion criteria

  • Patients receiving anti-depression therapy during the first 6 months of gestation or during pregnancy;
  • Patients with severe depression with scores of no less than 35 points in the HAMD questionnaire;
  • Patients with other mental disorders;
  • Patients with neurological diseases;
  • Patients with cognitive dysfunction.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 5 centers
  • The People's Hospital of Yubei District of Chongqing City — Chongqing
  • Chongqing First People's Hospital of Liangjiang New Area — Chongqing
  • The Central Hospital of Jiangjin District of Chongqing City — Chongqing
  • Wanzhou Health Center for Women and Children — Chongqing
  • The Maternal and Child Health Hospital of Hainan Province — Haikou

Publications

  • Zeng J, Chen L, Wang Z, Chen Q, Fan Z, Jiang H, Wu Y, Ren L, Chen J, Li T, Song W. Marginal vitamin A deficiency facilitates Alzheimer's pathogenesis. Acta Neuropathol. 2017 Jun;133(6):967-982. doi: 10.1007/s00401-017-1669-y. Epub 2017 Jan 27. PMID 28130638
  • Zeng J, Li T, Gong M, Jiang W, Yang T, Chen J, Liu Y, Chen L. Marginal Vitamin A Deficiency Exacerbates Memory Deficits Following Abeta1-42 Injection in Rats. Curr Alzheimer Res. 2017;14(5):562-570. doi: 10.2174/1567205013666161223162110. PMID 28017127
  • Liu Y, Chen Q, Wei X, Chen L, Zhang X, Chen K, Chen J, Li T. Relationship between perinatal antioxidant vitamin and heavy metal levels and the growth and cognitive development of children at 5 years of age. Asia Pac J Clin Nutr. 2015;24(4):650-8. doi: 10.6133/apjcn.2015.24.4.25. PMID 26693750
  • Hanson C, Lyden E, Furtado J, Van Ormer M, Schumacher M, Kamil A, McGinn E, Rilett K, Elliott E, Cave C, Johnson R, Weishaar K, Anderson-Berry A. Vitamin E status and associations in maternal-infant Dyads in the Midwestern United States. Clin Nutr. 2019 Apr;38(2):934-939. doi: 10.1016/j.clnu.2018.02.003. Epub 2018 Feb 20. PMID 29496275
  • Biederman J, Faraone SV. Attention-deficit hyperactivity disorder. Lancet. 2005 Jul 16-22;366(9481):237-48. doi: 10.1016/S0140-6736(05)66915-2. PMID 16023516
  • Barker DJ, Osmond C. Infant mortality, childhood nutrition, and ischaemic heart disease in England and Wales. Lancet. 1986 May 10;1(8489):1077-81. doi: 10.1016/s0140-6736(86)91340-1. PMID 2871345
  • Lin Y, Xu J, Huang J, Jia Y, Zhang J, Yan C, Zhang J. Effects of prenatal and postnatal maternal emotional stress on toddlers' cognitive and temperamental development. J Affect Disord. 2017 Jan 1;207:9-17. doi: 10.1016/j.jad.2016.09.010. Epub 2016 Sep 19. PMID 27665073
  • Ferguson SS. Receptor tyrosine kinase transactivation: fine-tuning synaptic transmission. Trends Neurosci. 2003 Mar;26(3):119-22. doi: 10.1016/S0166-2236(03)00022-5. PMID 12591212

Identifiers

NCT: NCT04017286 · CLi

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗