Healthy NutritionNCT05476289
A Follow-up Study of Dragon Study (NCT03520764): to Assess the Growth and Immune-related Outcomes
An observational study of Healthy Nutrition, run by Danone Nutricia at 1 site in China.
Trial summary
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]. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy Nutrition
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2018to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of healthy term-born children who completed the intervention period visit (from Day 0-44 to Week 17) of the preceding Dragon study, irrespective of whether they participated in one of the randomised groups or in the breastfeeding reference group. In total, 226 subjects had completed the Week 17 visit in the Dragon study. The subjects will be enrolled in the Dragon follow up after obtaining informed consent from their parents for the follow-up study.
Who may be able to join
- 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.
Who cannot join
- Participated or currently in another interventional clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Healthy Nutrition
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| A | children who received partially hydrolyzed formula containing synbiotics in the first 17 weeks of life in the Dragon study. Receives: Other: No intervention | |
| B | children who received standard infant formula containing prebiotics in the first 17 weeks of life in the Dragon study. Receives: Other: No intervention | |
| C | children who received full breastfeeding in the first 17 weeks of life in the Dragon study. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
- 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
Measured: 12-month to 4-year age
Allergy
- 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)
Measured: 12-month to 4-year age
Infections
- 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
Measured: 12-month to 4-year age
Stool microbiota
Stool microbiota at the enrolment and 4 years of age
Measured: 3-year age to 4-year age
Gastrointestinal symptoms
- 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.
Measured: 12-month to 4-year age
Medications
- 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
Measured: 12-month to 4-year age
Hospitalisation
- 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.
Measured: 12-month to 4-year age
Parental outcomes
- Parental loss of productive working days due to the child's allergic manifestations, allergies or infections.
Measured: 12-month to 4-year age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start29 Jan 2018
- Primary completion17 Nov 2021
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Nutricia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutricia Early Life Nutrition (Shanghai) Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476289
- Sponsor's protocol ID
- ELNCN2204
- Status last verified
- Sep 2024
- First submitted
- 21 Jul 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05476289
- Acronym / sponsor ID
- ELNCN2204
- Conditions
- Healthy Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Danone NutriciaIndustry (pharma, biotech, devices)
- Collaborators
- Nutricia Early Life Nutrition (Shanghai) Co., Ltd
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: No interventionchildren who received partially hydrolyzed formula containing synbiotics in the first 17 weeks of life in the Dragon study. |
| B | – | Other: No interventionchildren who received standard infant formula containing prebiotics in the first 17 weeks of life in the Dragon study. |
| C | – | Other: No interventionchildren who received full breastfeeding in the first 17 weeks of life in the Dragon study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of healthy term-born children who completed the intervention period visit (from Day 0-44 to Week 17) of the preceding Dragon study, irrespective of whether they participated in one of the randomised groups or in the breastfeeding reference group. In total, 226 subjects had completed the Week 17 visit in the Dragon study. The subjects will be enrolled in the Dragon follow up after obtaining informed consent from their parents for the follow-up study.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Participated or currently in another interventional clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | A, B, C |
Primary outcome
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
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)
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
Stool microbiota
Time frame: 3-year age to 4-year age
Stool microbiota at the enrolment and 4 years of age
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.
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Nutrition, run by Danone Nutricia at 1 site 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth (time frame: 12-month to 4-year age). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.