AzTrials
AzTrials

Children Behavior ProblemAPCSAHAODBONCT04017286

Relationship About Pregnancy Health and Offspring Developmental &Behavioral Outcomes

An observational study of Children Behavior Problem and Pregnancy, run by Chen Li at 5 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 3 to 72 months
Conditions the study is for
Children Behavior Problem, Pregnancy
How many people
3,000 participants
Where
5 sitesChina
Study dates
1 Jul 2019to 31 Dec 2028
How long will I take part?
6 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 72 months
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • 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;

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Li Chen, MD contact

(+86)136 7762 0103 ext. +86

chenli2012@126.com

5 sites in 1 country

China5 sites, 5 recruiting

  • The People's Hospital of Yubei District of Chongqing City

    Chongqing, Chongqing Municipality, 401120

    chun Y Su, MD, (+86)189 9613 7157 ext. +86, 1501614339@qq.com

    Not yet recruiting

  • Chongqing First People's Hospital of Liangjiang New Area

    Chongqing, Chongqing Municipality, 401121

    Chao Li, MB, (+86)13896164470 ext. +86, 695040138@qq.com

    Not yet recruiting

  • The Central Hospital of Jiangjin District of Chongqing City

    Chongqing, Chongqing Municipality, 402260

    Feng Li, Master, (+86)136 6801 9599 ext. +86, 123495256@qq.com

    Not yet recruiting

  • Wanzhou Health Center for Women and Children

    Chongqing, Chongqing Municipality, 404100

    zhi W Shen, Master, (+86)137 0945 8848 ext. +86, 13709458848@126.com

    Recruiting

  • The Maternal and Child Health Hospital of Hainan Province

    Haikou, Hainan, 570000

    Ling Li, Master, (+86)186 8985 3985 ext. +86, liling53985@126.com

    Not yet recruiting

Other trials in China

About this study

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

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 .

Read the 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).
  3. 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.
  4. 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.
  5. 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.
  6. Data management and statistical analysis plan:
  7. 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.
  8. Recruitment process:
  9. 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.
  10. 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.).
  11. 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.
  12. Risk Assessment ( illustrate the possible risk rate and take measures to ensure that risk is minimized in a possible range):
  13. 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.
  14. 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.

  1. 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.
Keywords
Developmental assessment, Homocysteine, physique growth, nutrients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04017286
Study groupRoleWhat they receive
depressive disorder groupAt 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 groupNutrients (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 groupAt 21 weeks of pregnancy, pregnant women with depressive disorder and nutrient deficiency or insufficiency and their offspring were enrolled.
Neither groupAt 21 weeks of pregnancy, pregnant women without depressive disorder and nutrient deficiency or insufficiency and their offspring were enrolled.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 72 months

  2. 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.

    Measured: 72 months

  3. 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.

    Measured: 72 months

  4. 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.

    Measured: 72 months

  5. 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.

    Measured: 72 months

  6. 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.

    Measured: 72 months

  7. 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.

    Measured: delivery

  8. 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.

    Measured: 72 months

  9. 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).

    Measured: 72 months

Secondary outcomes (10)

  1. Beck depression rating scale

    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.

    Measured: 21 weeks of pregnancy

  2. Hamilton Depression Scale

    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.

    Measured: 21 weeks of pregnancy

  3. Mini-Mental State Examination

    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.

    Measured: 21 weeks of pregnancy

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

    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.

    Measured: 12 months

  5. Change of weight for height Z-score(WHZ)

    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.

    Measured: 72 months

  6. Change of the height for age Z-score(HAZ)

    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.

    Measured: 72 months

  7. Change of the weight for Age Z-score(WAZ)

    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.

    Measured: 72 months

  8. Ferritin

    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.

    Measured: 24 months

  9. Folate

    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.

    Measured: 24 months

  10. Activity of Daily Living Scale

    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.

    Measured: 21 weeks of pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2019
  2. Study start1 Jul 2019
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
Target duration
6 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04017286
Sponsor's protocol ID
CLi
Acronym
APCSAHAODBO
Status last verified
Jan 2021
First submitted
21 May 2018
Last updated
1 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data is confidential during the study.

Publications

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    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 27665073

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  • Vinkhuyzen AAE, Eyles DW, Burne THJ, Blanken LME, Kruithof CJ, Verhulst F, Jaddoe VW, Tiemeier H, McGrath JJ. Gestational vitamin D deficiency and autism-related traits: the Generation R Study. Mol Psychiatry. 2018 Feb;23(2):240-246. doi: 10.1038/mp.2016.213. Epub 2016 Nov 29.

    PubMed 27895322

  • Salucci S, Ambrogini P, Lattanzi D, Betti M, Gobbi P, Galati C, Galli F, Cuppini R, Minelli A. Maternal dietary loads of alpha-tocopherol increase synapse density and glial synaptic coverage in the hippocampus of adult offspring. Eur J Histochem. 2014 May 2;58(2):2355. doi: 10.4081/ejh.2014.2355.

    PubMed 24998923

  • 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.

    PubMed 26004094

  • 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.

    PubMed 28035465

  • 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.

    PubMed 28842258

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    PubMed 23933821

  • Zhao W, Li C, Shen WZ, Li KY, Cai YX, Li F, Fu H, Peng B, Chen J, Li TY, Chen L. Cord blood vitamin A and vitamin D levels in relation to physical growth in exclusively breastfed infants aged 0-6 months. Front Endocrinol (Lausanne). 2024 Jul 26;15:1394408. doi: 10.3389/fendo.2024.1394408. eCollection 2024.

    PubMed 39129921

Questions about this trial

What is this clinical trial studying?

An observational study of Children Behavior Problem and Pregnancy, run by Chen Li at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Li Chen, MD ((+86)136 7762 0103 ext. +86, chenli2012@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Denver Developmental Screening Test results within 72 months of age (time frame: 72 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04017286, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.

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