A Follow-up Study of Dragon Study (NCT03520764): to Assess the Growth and Immune-related Outcomes
NCT ID: NCT05476289
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
226 participants
OBSERVATIONAL
2018-01-29
2023-11-30
Brief Summary
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Detailed Description
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As required by relevant law issued by the National Health and Family Planning Commission in China, the maternal and children health network institutions in all provinces should carry out regular health assessments for children aged 0-6 years, in which the growth evaluations should be conducted for children aged 24 months, 30 months, 3 years and 4 years. In this follow-up study, the weight and height parameters will be obtained from the Children's Health Manual, and skinfolds thickness at 4 years of age will be measured on-site by trained personnel.
Except for stool microbiota collection and skinfold thickness measurement, all variables will be collected via our online tools. Data on growth parameters, allergy, infection, medications, and hospitalization will be collected using an electronic data capture system (EDC). Parents are expected to login to an electronic platform at a scheduled time from an Internet-accessible smartphone or tablet to fill the online questionnaire and send photocopies of examination results as required (any information related to personal privacy such as name, address and hospitalization ID should be covered before being taken a photocopy, see section 11.5). Parents will receive reminder short messages on the first day of the scheduled visit window. Those who fail to respond to the follow-up message in two weeks will receive a backup telephone call to complete the filling.
The gastrointestinal symptoms, stool assessment, skinfold thickness and dietary pattern and behaviour will only be collected prospectively. If the subjects' actual age at the enrolment is older than 4 year old, skinfolds thickness, gastrointestinal symptoms, stool assessment and dietary pattern and behaviour at 4 years of age will not be collected.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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A
children who received partially hydrolyzed formula containing synbiotics in the first 17 weeks of life in the Dragon study.
No intervention
No intervention
B
children who received standard infant formula containing prebiotics in the first 17 weeks of life in the Dragon study.
No intervention
No intervention
C
children who received full breastfeeding in the first 17 weeks of life in the Dragon study.
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* Children whose parents provide informed consent for participation in the Dragon Follow Up study.
Exclusion Criteria
ALL
No
Sponsors
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Nutricia Early Life Nutrition (Shanghai) Co., Ltd
UNKNOWN
Danone Nutricia
INDUSTRY
Responsible Party
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Locations
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Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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ELNCN2204
Identifier Type: -
Identifier Source: org_study_id
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