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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04444791
Other study ID # PUMCPublicHealth
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date December 1, 2020

Study information

Verified date June 2020
Source Peking Union Medical College
Contact Zhao Jian, Doctor
Phone 86+15645120652
Email 15645120652@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Purpose: To investigate the growth and development status for children of 1 ~ 3 years old in China, and to explore and analyze the influencing factors of infant growth. Mother's health status would also be investigated simultaneously.

Methods and analysis: This is a multicenter prospective cohort study. Participants were all from the Chinese Pregnant Women Cohort Study (CPWCS), which is a multicenter prospective cohort study we conducted before. In simple terms, pregnant women during the first trimester (5~13 weeks' gestational age) were included from 25 July 2017 to 26 November 2018. Related information were collected by electronic self-administered questionnaire, including general information, environmental exposure assessment, physical activity assessment, dietary and nutritional assessment, depression assessment, sleep quality assessment and economic burden assessment. Subsequently, objective medical information, obstetric and neonatal outcomes were collected through hospital information system (HIS).

To further assess the mothers' and infants' health status, a new multicenter prospective cohort study, including more than 1000 participants of the CPWCS from 5 hospitals of 5 different provinces in China, will be conducted. Through the electronic self-administered questionnaire surveys and laboratory testing methods, information about infants' feeding, sleeping, defecating, oral health, early development and common allergic diseases will be collected. And we will also assess mothers' current health habits and status, such as sleeping, diet, anxiety, physical activity, and oral health. SAS statistical software will be used for data analysis.

Ethics and Dissemination Permission for the study was obtained from Chinese Academy of Medical Sciences and Peking Union Medical College. Ethics approval was obtained from the Ethics Review Committee of Department of Scientific Research, School of Basic Medicine, Peking Union Medical College, Beijing, China. The results will be published in peer-reviewed journals or disseminated through conference presentations.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1978
Est. completion date December 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years and older
Eligibility Inclusion Criteria:

1. participated in the CPWCS and were pregnant women included in the previous cohort;

2. the baseline, first trimester, delivery outcomes, and neonatal outcomes data in the CPWCS were complete;

3. live birth and singleton in the CPWCS;

4. participate in the CPWCS-OF with child born in the CPWCS willingly;

5. able to complete the questionnaire;

6. resident in the study area;

7. signed the informed consent.

Exclusion Criteria:

1. subjects not included in the CPWCS;

2. incomplete data in either of baseline, first trimester, delivery outcomes, and neonatal outcomes in the CPWCS;

3. pregnancy outcomes in the CPWCS were not singleton (abortion, stillbirth, twins, multiple births);

4. no longer resident in the study area;

5. the child has died;

6. the mother currently has mental problems and cannot cooperate well with the research.

Study Design


Locations

Country Name City State
China School of Public Health, Peking Union Medical College Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Infants' and young children's feeding situation The mother will report these questions. 2020.8.1-2020.12.1
Primary Infants' sleeping conditions 2020.8.1-2020.12.1
Primary Infants' defecation situation 2020.8.1-2020.12.1
Primary Infants' oral development 2020.8.1-2020.12.1
Primary Infants' early development 2020.8.1-2020.12.1
Primary Mother' knowledge of infant oral health care 2020.8.1-2020.12.1
Primary Infants' physical health (asthma, allergies, autism) 2020.8.1-2020.12.1
Secondary Mothers' physical activity 2020.8.1-2020.12.1
Secondary Mothers' dietary patterns 2020.8.1-2020.12.1
Secondary Mothers' lifestyle (smoking, sleeping) 2020.8.1-2020.12.1
Secondary Mothers' anxiety condition 2020.8.1-2020.12.1
Secondary Mothers' oral health 2020.8.1-2020.12.1
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