To Investigate Effects of a New Infant Formula in Healthy Term Chinese Infants

N/ACompletedNCT03520764

Danone Nutricia284 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

284

Conditions

Healthy Infants

Interventions

Eligibility

Sex: ALLMax age: 44 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (6)

Peking University 3rd Hospital

Beijing, Beijing Municipality, China

Guangzhou women and Children's Medical Center

Guangzhou, Guangdong, China

Guangdong Province Maternal and Children Hospital

Guangzhou, Guangdong, China

Wuxi Poeple's Hospital

Wuxi, Jiangsu, China

Shanghai Public Health Clinical Research Center

Shanghai, Shanghai Municipality, China

Xin Hua Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Weight gain per day from baseline (g/day)

Time frame: at the age of 17 weeks

Secondary Outcomes

Weight gain per day from baseline (g/day) in infant receiving test product compared to breastfed infant.

Time frame: at the age of 17 weeks

Increment per day from baseline on length (mm/day)

Time frame: at the age of 17 weeks

Increment per day from baseline on head circumference (mm/day)

Time frame: at the age of 17 weeks

Increment per day from baseline on mid-upper arm circumference (mm/day)

Time frame: at the age of 17 weeks

Z-scores of anthropometric parameters from baseline on weight