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

NCT05476289 | Completed

• 1 other identifier: ELNCN2204
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

Brief 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 \[EBB16SI08406\]. 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.

Conditions

Healthy Nutrition

Outcome Measures

Primary Outcomes (8)

• 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

  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)

  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

  12-month to 4-year age

• Stool microbiota

  Stool microbiota at the enrolment and 4 years of age

  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.

  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

  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.

  12-month to 4-year age

• Parental outcomes

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

  12-month to 4-year age

Study Arms (3)

A

children who received partially hydrolyzed formula containing synbiotics in the first 17 weeks of life in the Dragon study.

Other: No intervention

B

children who received standard infant formula containing prebiotics in the first 17 weeks of life in the Dragon study.

Other: No intervention

C

children who received full breastfeeding in the first 17 weeks of life in the Dragon study.

Other: No intervention

Interventions

No intervention OTHER

No intervention

A; B; C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Participated or currently in another interventional clinical trial.

Sponsors & Collaborators

• Danone Nutricia: lead
• Nutricia Early Life Nutrition (Shanghai) Co., Ltd: collaborator

Study Sites (1)

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

Shanghai, Shanghai Municipality, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool Sample will be retained on Baseline visit and Visit 4 (48months)

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 27, 2022
• Study Start: January 29, 2018
• Primary Completion: November 17, 2021
• Study Completion: November 30, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)