Relationship About Pregnancy Health and Offspring Developmental &Behavioral Outcomes

NCT04017286 | Recruiting

• 1 other identifier: CLi
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 5

Brief Summary

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 .

Conditions

Children Behavior Problem; Pregnancy

Keywords

Developmental assessment; Homocysteine; physique growth; nutrients

Outcome Measures

Primary Outcomes (9)

• Changes in Denver Developmental Screening Test results within 72 months of age

  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.

  72 months

• Changes in Gesell Developmental Schedules test results within 72 months of age

  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.

  72 months

• The Vanderbilt Attention Deficit Hyperactivity Disorder Diagnostic Rating Scale

  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.

  72 months

• Changes in vitamin A

  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.

  72 months

• Changes in Vitamin D

  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.

  72 months

• Changes in Vitamin E

  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.

  72 months

• Homocysteine

  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.

  delivery

• Bisphenol A

  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.

  72 months

• the Adaptive Scale of Infant and Children

  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).

  72 months

Secondary Outcomes (10)

• Beck depression rating scale

  21 weeks of pregnancy

• Hamilton Depression Scale

  21 weeks of pregnancy

• Mini-Mental State Examination

  21 weeks of pregnancy

• Changes in the Montreal Children Hospital Feeding Scale within 12 months of age

  12 months

• Change of weight for height Z-score(WHZ)

  72 months

Study Arms (4)

depressive disorder group

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.

Nutrient-deficient group

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.

depressive disorder and nutrient deficiency group

At 21 weeks of pregnancy, pregnant women with depressive disorder and nutrient deficiency or insufficiency and their offspring were enrolled.

Neither group

At 21 weeks of pregnancy, pregnant women without depressive disorder and nutrient deficiency or insufficiency and their offspring were enrolled.

Eligibility Criteria

• Age: 3 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chen Li: lead

Study Sites (5)

The People's Hospital of Yubei District of Chongqing City

Chongqing, Chongqing Municipality, 401120, China

NOT YET RECRUITING

Chongqing First People's Hospital of Liangjiang New Area

Chongqing, Chongqing Municipality, 401121, China

NOT YET RECRUITING

The Central Hospital of Jiangjin District of Chongqing City

Chongqing, Chongqing Municipality, 402260, China

NOT YET RECRUITING

Wanzhou Health Center for Women and Children

Chongqing, Chongqing Municipality, 404100, China

RECRUITING

The Maternal and Child Health Hospital of Hainan Province

Haikou, Hainan, 570000, China

NOT YET RECRUITING

Related Publications (15)

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• 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.

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• Hanson M. The birth and future health of DOHaD. J Dev Orig Health Dis. 2015 Oct;6(5):434-7. doi: 10.1017/S2040174415001129. Epub 2015 May 25.

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• Zhao H, Nyholt DR. Gene-based analyses reveal novel genetic overlap and allelic heterogeneity across five major psychiatric disorders. Hum Genet. 2017 Feb;136(2):263-274. doi: 10.1007/s00439-016-1755-6. Epub 2016 Dec 29.

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• Dias CC, Figueiredo B, Pinto TM. Children's Sleep Habits Questionnaire - Infant Version. J Pediatr (Rio J). 2018 Mar-Apr;94(2):146-154. doi: 10.1016/j.jped.2017.05.012. Epub 2017 Aug 23.

  PMID: 28842258 BACKGROUND

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  PMID: 39129921 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

In the investigator's study, partly samples of material from research participants are retained in a biorepository.For example, cord blood from newborn, DNA, venous blood and urine. A few of hair is also collected at the same time and stored for future measurements (used to extract DNA in case that the cord blood is unsufficient or DNA extraction from the blood fails unexpectedly).

Study Officials

• Li Chen, MD

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

• Tanya Froehlich, MD,MS

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• yu T Li, MS

  Children's Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

Li Chen, MD

CONTACT

(+86)136 7762 0103; chenli2012@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Director, Professor

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: July 12, 2019
• Study Start: July 1, 2019
• Primary Completion: July 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)