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Completed

NCT Number: NCT05476289

A Follow-up Study of Dragon Study (NCT03520764): to Assess the Growth and Immune-related Outcomes

Dragon follow-up aims to evaluate the growth, allergies, and infections of Chinese subjects up to four years of age who completed the intervention period visit (from Day 0-44 to Week 17) of the Dragon study [EBB16SI08406]. This study aims to provide insights into the role of usage of a partially hydrolyzed formula with added synbiotics in early life children's growth and immune-related outcome up to 4 years of age.

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Key information

Conditions

Healthy Nutrition

Sex eligibility

All sexes

Study type

Observational

Primary location

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

About this study

After providing informed consent, subjects from the prior randomized controlled trial (Dragon study) will be enrolled in the follow-up study. The observation period is from the end of the Dragon study (12 months) to 4 years of age. Data from the end of the Dragon study to the actual age at the enrolment (with 4 years of age as the upper limit) will be collected retrospectively, and data from the actual age at the enrolment (if younger than 4 years of age) to 4 years of age will be collected prospectively. Data will be collected retrospectively or prospectively at four scheduled visit timepoints: 24 months, 30 months, 3 years and 4 years of age. The visit points are in accordance with the health assessment schedule of the Maternal and Children Health Network in China to ensure the data on growth before the start of this follow-up study is available.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children completed the intervention period visits (from Day 0-44 to Week 17) of the Dragon study in one of the randomized groups or in the breastfeeding reference group.
  • Children whose parents provide informed consent for participation in the Dragon Follow Up study.

Exclusion criteria

  • Participated or currently in another interventional clinical trial.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Growth

    Time frame: 12-month to 4-year age

    • Weight, weight gain, height, Body Mass Index (BMI) at 24 months, 30 months, 3 years and 4 years of age
    • Skin folds thickness at 4 years of age
    • Individual skin folds thickness (triceps, biceps, subscapular, suprailiac)
    • Sum of all 4 skin folds thickness
    • Subcutaneous trunk fat (sum of subscapular and suprailiac skinfolds)
    • Subcutaneous peripheral fat (sum of triceps and biceps)
    • Z-score of the following anthropometric parameters up to 4 years of age according to World Health Organization (WHO) growth chart:
    • Height-for-age
    • Weight-for-age
    • BMI-for-age
    • Weight-for-height
    • Subscapular skinfold-for-age
    • Triceps skinfold-for-age

  2. Allergy

    Time frame: 12-month to 4-year age

    • The occurrence of parent reported allergic manifestations and doctor diagnosed allergies (as reported by parents and noted in the subject's medical dossier) at 24 months, 30 months, 3 years and 4 years of age.
    • Respiratory: Wheeze and asthma
    • Skin: Eczema, atopic dermatitis, urticaria
    • Food: Adverse reactions to foods and food allergy (the types of foods that result in allergy should be recorded)
    • Other: Rhinitis (allergic responses to pollen, house dust mite)

  3. Infections

    Time frame: 12-month to 4-year age

    • The occurrence of parent-reported infections symptoms and doctor diagnosed infections (as reported by parents and noted in the subject's medical dossier) at 24 months, 30 months, 3 years and 4 years of age. In particular,
    • Fever
    • Respiratory infections; upper respiratory tract infections, nasopharyngitis, bronchitis/bronchiolitis, pneumonia)
    • Ear infections
    • Skin infections; dermatitis
    • GI infections

  4. Stool microbiota

    Time frame: 3-year age to 4-year age

    Stool microbiota at the enrolment and 4 years of age

  5. Gastrointestinal symptoms

    Time frame: 12-month to 4-year age

    • The occurrence of any gastrointestinal discomfort symptoms in the past 4 weeks, including vomiting, abdominal pain, constipation, diarrhea at the enrolment and 4 years of age.

  6. Medications

    Time frame: 12-month to 4-year age

    • The use of medications and/or a medical device (inhaler) to prevent or relieve allergic manifestations and allergies or infections (as reported by parents and/or noted in the subject's medical dossier).
    • Probiotics and other nutritional supplements

  7. Hospitalisation

    Time frame: 12-month to 4-year age

    • Number of days hospitalised for allergic manifestations, allergies or infections (reported by parents and/or noted in the subject's medical dossier).
    • Number of visits to the emergency room, outpatient departments or clinics for allergic manifestations, allergies and infections.

  8. Parental outcomes

    Time frame: 12-month to 4-year age

    • Parental loss of productive working days due to the child's allergic manifestations, allergies or infections.

Sponsors and collaborators

Lead sponsor

Danone Nutricia

Industry

Collaborators

  • Nutricia Early Life Nutrition (Shanghai) Co., Ltd

Registry information

Official study title

Effect of a Partially Hydrolyzed Formula with Added Synbiotics on Growth and Immune-related Outcomes in Chinese Children Up to Four Years of Age: a Follow-up Study of a Clinical Trial in the First Year of Life

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Jul 27, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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