Clinical trial NCT03520764: To Investigate Effects of a New Infant Formula in Healthy Term Chinese Infants
Official title: A Randomised, Controlled, Double-blind Study to Investigate the Effects of a New Infant Formula on Growth, Safety, and Tolerance in Healthy Term Chinese Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Infants
Lead sponsor: Danone Nutricia
Sponsor class: INDUSTRY
Collaborators: name: Nutricia Early Life Nutrition (Shanghai) Co., Ltd
First posted: 2018-05-11
Enrollment: 284
Sex: ALL
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group: New infant formula with synbiotics; Control group: Standard infant formula with prebiotics
Primary purpose: OTHER

Brief summary: This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants.

Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. The total duration of the study is around 12 months which includes 8 study visits.

Infants, whose mother has the intention to fully breastfeed her infant at least until 17 weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother has the intention to fully formula feed her infant as of 44 days of age at the latest, will be randomized to receive either the investigational product or control product until infants reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and continue be followed up until 12 months of age.

Safety, growth and tolerance parameters will be followed and collected throughout the study.


Eligibility criteria: Inclusion Criteria:

1. Healthy Chinese term infants ≤ 44 days
2. Birth weight within normal range
3. Head circumference within normal range
4. Fully formula fed by the time of randomization OR fully breastfed and with intention to fully breastfeed until 17 weeks of age

Exclusion Criteria:

- The mothers of infants:

1. who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;
2. known to have a significant medical condition that might interfere with the study or known to affect intra-uterine growth, as per investigator's clinical judgement;

   - Parents/Legally acceptable representatives/Caregivers of infants:
3. who are incapable to comply with study protocol

   - Infants:
4. who have to be fed with a special diet other than standard cow's milk based infant formula;
5. known to have current or previous illnesses/conditions which could interfere with the study products or its outcome parameters
6. known or suspected to have an allergic condition towards cow's milk, soy or fish;
7. with any history of, or current participation in any other study involving investigational or marketed products.

Primary outcomes:
measure: Weight gain per day from baseline (g/day)
timeFrame: at the age of 17 weeks
Secondary outcomes:
measure: Weight gain per day from baseline (g/day) in infant receiving test product compared to breastfed infant.
timeFrame: at the age of 17 weeks
measure: Increment per day from baseline on length (mm/day)
timeFrame: at the age of 17 weeks
measure: Increment per day from baseline on head circumference (mm/day)
timeFrame: at the age of 17 weeks
measure: Increment per day from baseline on mid-upper arm circumference (mm/day)
timeFrame: at the age of 17 weeks
measure: Z-scores of anthropometric parameters from baseline on weight
timeFrame: from baseline until the age of 17 weeks
measure: Z-scores of anthropometric parameters from baseline on length
timeFrame: from baseline until the age of 17 weeks
measure: Z-scores of anthropometric parameters from baseline on head circumference
timeFrame: from baseline until the age of 17 weeks
measure: Z-scores of anthropometric parameters from baseline on mid-upper arm circumference
timeFrame: from baseline until the age of 17 weeks
measure: Effect on incidence, frequency and severity of (serious) adverse events
timeFrame: from baseline until the age of 17 weeks
measure: Parent-reported occurrence of diarrhea
timeFrame: from baseline until the age of 17 weeks
measure: Parent-reported severity of diarrhea
timeFrame: from baseline until the age of 17 weeks
measure: Parent-reported occurrence of constipation
timeFrame: from baseline until the age of 17 weeks
measure: Parent-reported severity of constipation
timeFrame: from baseline until the age of 17 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University 3rd Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou women and Children's Medical Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Province Maternal and Children Hospital
state: Guangdong
city: Wuxi
country: China
facility: Wuxi Poeple's Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Research Center
state: Shanghai
city: Shanghai
country: China
facility: Xin Hua Hospital
state: Shanghai
Study officials:
References: