Studies
| Study First Submitted Date | 2018-05-21 |
| Study First Posted Date | 2019-07-12 |
| Last Update Posted Date | 2021-02-01 |
| Start Month Year | July 1, 2019 |
| Primary Completion Month Year | July 31, 2025 |
| Verification Month Year | January 2021 |
| Verification Date | 2021-01-31 |
| Last Update Posted Date | 2021-02-01 |
Detailed Descriptions
| Sequence: | 20662299 |
| Description | 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.
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. 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. 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. 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. 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.). 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. 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. 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. |
Facilities
| Sequence: | 199440401 | Sequence: | 199440402 | Sequence: | 199440403 | Sequence: | 199440404 | Sequence: | 199440405 |
| Status | Not yet recruiting | Status | Not yet recruiting | Status | Not yet recruiting | Status | Recruiting | Status | Not yet recruiting |
| Name | The People’s Hospital of Yubei District of Chongqing City | Name | Chongqing First People’s Hospital of Liangjiang New Area | Name | The Central Hospital of Jiangjin District of Chongqing City | Name | Wanzhou Health Center for Women and Children | Name | The Maternal and Child Health Hospital of Hainan Province |
| City | Chongqing | City | Chongqing | City | Chongqing | City | Chongqing | City | Haikou |
| State | Chongqing | State | Chongqing | State | Chongqing | State | Chongqing | State | Hainan |
| Zip | 401120 | Zip | 401121 | Zip | 402260 | Zip | 404100 | Zip | 570000 |
| Country | China | Country | China | Country | China | Country | China | Country | China |
Facility Contacts
| Sequence: | 28029424 | Sequence: | 28029425 | Sequence: | 28029426 | Sequence: | 28029427 | Sequence: | 28029428 |
| Facility Id | 199440401 | Facility Id | 199440402 | Facility Id | 199440403 | Facility Id | 199440404 | Facility Id | 199440405 |
| Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary |
| Name | chun Y Su, MD | Name | Chao Li, MB | Name | Feng Li, Master | Name | zhi W Shen, Master | Name | Ling Li, Master |
| [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | |||||
| Phone | (+86)189 9613 7157 | Phone | (+86)13896164470 | Phone | (+86)136 6801 9599 | Phone | (+86)137 0945 8848 | Phone | (+86)186 8985 3985 |
| Phone Extension | +86 | Phone Extension | +86 | Phone Extension | +86 | Phone Extension | +86 | Phone Extension | +86 |
Conditions
| Sequence: | 52016506 | Sequence: | 52016507 |
| Name | Children Behavior Problem | Name | Pregnancy |
| Downcase Name | children behavior problem | Downcase Name | pregnancy |
Id Information
| Sequence: | 40037434 |
| Id Source | org_study_id |
| Id Value | CLi |
Countries
| Sequence: | 42433782 |
| Name | China |
| Removed | False |
Design Groups
| Sequence: | 55423015 | Sequence: | 55423016 | Sequence: | 55423017 | Sequence: | 55423018 |
| Title | depressive disorder group | Title | Nutrient-deficient group | Title | depressive disorder and nutrient deficiency group | Title | Neither group |
| Description | At 21 weeks of pregnancy, women diagnosed with depressive disorder by the Hamilton depression scale and Beck depression rating scale and their offspring were enrolled. | Description | Nutrients (Vitamin A,D,E) were tested at 21 weeks of pregnancy, and pregnant women with one or more nutrient deficiencies or insufficiency and their offspring were enrolled. | Description | At 21 weeks of pregnancy, pregnant women with depressive disorder and nutrient deficiency or insufficiency and their offspring were enrolled. | Description | At 21 weeks of pregnancy, pregnant women without depressive disorder and nutrient deficiency or insufficiency and their offspring were enrolled. |
Keywords
| Sequence: | 79620033 | Sequence: | 79620034 | Sequence: | 79620035 | Sequence: | 79620036 |
| Name | Developmental assessment | Name | Homocysteine | Name | physique growth | Name | nutrients |
| Downcase Name | developmental assessment | Downcase Name | homocysteine | Downcase Name | physique growth | Downcase Name | nutrients |
Design Outcomes
| Sequence: | 176840425 | Sequence: | 176840426 | Sequence: | 176840427 | Sequence: | 176840428 | Sequence: | 176840429 | Sequence: | 176840430 | Sequence: | 176840431 | Sequence: | 176840432 | Sequence: | 176840433 | Sequence: | 176840434 | Sequence: | 176840435 | Sequence: | 176840436 | Sequence: | 176840437 | Sequence: | 176840438 | Sequence: | 176840439 | Sequence: | 176840440 | Sequence: | 176840441 | Sequence: | 176840442 | Sequence: | 176840443 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Changes in Denver Developmental Screening Test results within 72 months of age | Measure | Changes in Gesell Developmental Schedules test results within 72 months of age | Measure | The Vanderbilt Attention Deficit Hyperactivity Disorder Diagnostic Rating Scale | Measure | Changes in vitamin A | Measure | Changes in Vitamin D | Measure | Changes in Vitamin E | Measure | Homocysteine | Measure | Bisphenol A | Measure | the Adaptive Scale of Infant and Children | Measure | Beck depression rating scale | Measure | Hamilton Depression Scale | Measure | Mini-Mental State Examination | Measure | Changes in the Montreal Children Hospital Feeding Scale within 12 months of age | Measure | Change of weight for height Z-score(WHZ) | Measure | Change of the height for age Z-score(HAZ) | Measure | Change of the weight for Age Z-score(WAZ) | Measure | Ferritin | Measure | Folate | Measure | Activity of Daily Living Scale |
| Time Frame | 72 months | Time Frame | 72 months | Time Frame | 72 months | Time Frame | 72 months | Time Frame | 72 months | Time Frame | 72 months | Time Frame | delivery | Time Frame | 72 months | Time Frame | 72 months | Time Frame | 21 weeks of pregnancy | Time Frame | 21 weeks of pregnancy | Time Frame | 21 weeks of pregnancy | Time Frame | 12 months | Time Frame | 72 months | Time Frame | 72 months | Time Frame | 72 months | Time Frame | 24 months | Time Frame | 24 months | Time Frame | 21 weeks of pregnancy |
| Description | The DDST is taking at the age of 12 months,24 months,36months and 72months respectively ,consists of 104 items, spread 4 domains, such as gross motor, fine motor, language and personal-social skill. A normal score means no delay in any domain and no more than one caution; an abnormal score means two or more domains with two or more delays or one domain with two or more delays and another domains with one delay; a suspect score means one or more domains with one delay and more than one cautions or one domain with two or more delays; a score of untestable means enough refused items that the score would be suspect if they had been delays. | Description | The GDS is taking at the age of 12 months,24 months, 36 months and 72 months respectively , evaluate a child’s cognitive, language, motor and social-emotional responses in five strands: adaptation, gross motor, fine motor, language and personal-social skill, then schedule operates off what is known as an individual’s developmental quotient (DQ). Diagnostic criteria: the score of DQ≥86: normal, 76-85: marginal , 55-75: mild mental retardation, 40-54: moderate mental retardation, 25-39: severe mental retardation, and ≤25 : extremely severe mental retardation. | Description | The Vanderbilt ADHD Diagnostic Rating Scale (VADRS) is for children at the age of 72 months. Scores of 2 or 3 on a single Symptom question reflect often-occurring behaviors. Scores of 4 or 5 on Performance questions reflect problems in performance. To meet the diagnosis of ADHD, one must have at least 6 positive responses to either the inattentive 9 or hyperactive 9 core symptoms, or both. | Description | Vitamin A is measured for the mothers at first visit during 21 weeks of gestation and delivery, for the children is 24 months, 36 months and 72 months respectively. It is measured by HPLC and tandem mass spectrometry. And it is considered as Vitamin A deficiency when the concentration is below 0.70 umol/L, 0.70-1.05 umol/L is considered as marginal vitamin A deficiency, 1.05-2.56 umol/L is considered as normal range, and over 2.56 umol/L is considered as Vitamin A excess. | Description | Vitamin D is measured for the mothers at first visit during 21 weeks of gestation and delivery, for the children is 24 months, 36 months and 72 months respectively. It is measured by HPLC and tandem mass spectrometry. the measurement of the concentration of 25-OH-D3 as that of vitamin D. It is below 30 nmol/L considered as Vitamin D deficiency, 30-50 nmol/L considered as Vitamin D insufficiency, over 50 nmol/L considered as Vitamin D sufficiency. | Description | Vitamin E is measured for the mothers at first visit during 21 weeks of gestation and delivery, for the children is 24 months, 36 months and 72 months respectively. It is measured by HPLC and tandem mass spectrometry. It is normal range with the concentration of 11.6-46.4 umol/L. | Description | Homocysteine is measured for the mothers at first visit during 21 weeks of gestation and delivery. It is measured by HPLC and tandem mass spectrometry. The concentration of homocysteine less than 11.4umol/L is normal for men and less than 10.4 umol/L for women. | Description | The concentration of bisphenol A is measured for mother at delivery and for children aged 2 and 6. The investigators measured the concentration of urine in order to compare the differences of children between high dose of BPA with low dose of BPA. However, as far as we know, the normal range of bisphenol A has not been reported at home and abroad. We also want to explore the relationship between bisphenol A and neuropsychiatric development. | Description | This scale is assessed for the children at the age of 72 months. Extremely low (≤5), severely low (6 points), moderately low (8 points), marginal (9 points), normal (10 points), more than normal (11 points), excellent (12 points), very good (13 points). | Description | The investigators assess Beck depression rating scale the severity of depression of the women at 21 weeks of pregnancy by Beck depression rating scale, a 21-items questionnaire. Scoring criteria: 0-13: good mental state, 14-19: mildly depressed, 20-28: moderately depressed, 29-63: severe depression. | Description | The investigators assess the mood of the pregnant women at 21 weeks of pregnancy by the scale. Total score < 8: normal; A score of 8 to 20: possible depression; A score of 20 to 35: depression; Overall score > 35: major depression. | Description | The investigators screened the questionnaire to assess cognitive impairment of the pregnant women at 21 weeks of pregnancy. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. | Description | The scale measured for the children aged 6 months and 12 months respectively. The score previously calculated is the original score without standardization (rough score), and the total score of the scale (rough score) is 14-98, and then the rough score is converted into standardized score. If the standard score is less than or equal to 50, there is no difficulty in feeding; if the standard score is 51-60, there is mild difficulty in feeding; if the standard score is 61-70, there is moderate difficulty in feeding; if the standard score is greater than 70, there is severe difficulty in feeding. | Description | The measurement of body length/height and weight (the average of three consecutive measurements) for age is at 3 months, 6 months,12 months,24 months,36 months and 72 months respectively and calculated by WHO2006 curve. It’s considered abnormal when the WHZ is below P3 or over P97, the normal range is between P3~P97. | Description | The measurement of body length/height (the average of three consecutive measurements) for age is at 3 months, 6 months,12 months , 24 months, 36 months and 72 months respectively and calculated by WHO2006 curve. It’s considered abnormal when the HAZ is below P3 or over P97, the normal range is between P3~P97. | Description | The measurement of weight (the average of three consecutive measurements) for age is at 3 months, 6 months,12 months , 24 months, 36 months and 72 months respectively and calculated by WHO2006 curve . It’s considered abnormal when the WAZ is below P3 or over P97, the normal range is between P3~P97. | Description | The ferritin is measured for mothers at 21 weeks of pregnancy and for children at the age of 24 months. It is measured by chemiluminescence method. It is normal when the concentration of ferritin is between 5-148 ng/ml for girls and 28-365 ng/ml for boys. | Description | The folate is measured for mothers at 21 weeks of pregnancy and for children at the age of 24 months. It is measured by chemiluminescence method. It is normal when the concentration of folate is greater than 5.38 ng/ml. | Description | The investigators screened the questionnaire to assess cognitive impairment of the pregnant women at 21 weeks of pregnancy. ADLs can be broken down into the following categories: personal hygiene, continence management, dressing, feeding, ambulating. The evaluation results can be analyzed according to the total score, subscale score and single score. The total score < 16 points, completely normal; > 16 points, with varying degrees of functional decline, and the maximum score is 64 points. Single points; 1 point :normal, 2-4 points : functional decline.≥2 items with a score ≥3 points, or a total score ≥ 22 points, are considered to have obvious dysfunction. |
Browse Conditions
| Sequence: | 192873537 | Sequence: | 192873538 |
| Mesh Term | Problem Behavior | Mesh Term | Behavioral Symptoms |
| Downcase Mesh Term | problem behavior | Downcase Mesh Term | behavioral symptoms |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48175041 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Chen Li |
Overall Officials
| Sequence: | 29196253 | Sequence: | 29196254 | Sequence: | 29196255 |
| Role | Study Director | Role | Principal Investigator | Role | Study Chair |
| Name | Li Chen, MD | Name | Tanya Froehlich, MD,MS | Name | yu T Li, MS |
| Affiliation | Children’s Hospital of Chongqing Medical University | Affiliation | Children’s Hospital Medical Center, Cincinnati | Affiliation | Children’s Hospital of Chongqing Medical University |
Central Contacts
| Sequence: | 11974435 |
| Contact Type | primary |
| Name | Li Chen, MD |
| Phone | (+86)136 7762 0103 |
| [email protected] | |
| Phone Extension | +86 |
| Role | Contact |
Eligibilities
| Sequence: | 30674762 |
| Sampling Method | Probability Sample |
| Gender | All |
| Minimum Age | 3 Months |
| Maximum Age | 72 Months |
| Healthy Volunteers | No |
| Population | This study is based on source material from Chongqing suburban maternity and child health hospital. The investigators randomly select the pregnant women aged 20 to 49 from the pregnancy clinics and obstetric wards, respectively construct mother-child matching and a prospective study cohort depending on whether the pregnant women with major depressive disorder or not, nutrition state of vitamin A, D, E, during pregnancy. |
| Criteria | Inclusion Criteria:
Inclusion criteria for pregnant women: Aged 20~49; Exclusion Criteria: Patients receiving anti-depression therapy during the first 6 months of gestation or during pregnancy; |
| Adult | False |
| Child | True |
| Older Adult | False |
Calculated Values
| Sequence: | 253863999 |
| Number Of Facilities | 5 |
| Registered In Calendar Year | 2018 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | False |
| Minimum Age Num | 3 |
| Maximum Age Num | 72 |
| Minimum Age Unit | Months |
| Maximum Age Unit | Months |
| Number Of Primary Outcomes To Measure | 9 |
| Number Of Secondary Outcomes To Measure | 10 |
Designs
| Sequence: | 30421523 |
| Observational Model | Cohort |
| Time Perspective | Prospective |
Responsible Parties
| Sequence: | 28788048 |
| Responsible Party Type | Sponsor-Investigator |
| Name | Chen Li |
| Title | Vice Director, Professor |
| Affiliation | Children’s Hospital of Chongqing Medical University |
Study References
| Sequence: | 51905693 | Sequence: | 51905694 | Sequence: | 51905695 | Sequence: | 51905696 | Sequence: | 51905697 | Sequence: | 51905698 | Sequence: | 51905699 | Sequence: | 51905700 | Sequence: | 51905701 | Sequence: | 51905702 | Sequence: | 51905703 | Sequence: | 51905704 | Sequence: | 51905705 | Sequence: | 51905706 |
| Pmid | 28130638 | Pmid | 28017127 | Pmid | 26693750 | Pmid | 29496275 | Pmid | 16023516 | Pmid | 2871345 | Pmid | 27665073 | Pmid | 12591212 | Pmid | 27895322 | Pmid | 24998923 | Pmid | 26004094 | Pmid | 28035465 | Pmid | 28842258 | Pmid | 23933821 |
| Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
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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. | Citation | 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. Erratum In: Lancet. 2006 Jan 21;367(9506):210. | Citation | 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. | Citation | 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. | Citation | Ferguson SS. Receptor tyrosine kinase transactivation: fine-tuning synaptic transmission. 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