This is a randomized, open-label, prospective study to evaluate the nutritive effects of an a2 infant formula on growth and tolerance in healthy term infants. A total of 280 healthy, term, mixed-fed infants between 60 and 120 days of age were enrolled at Shanghai. The participants were randomly assigned to one of the two study groups: the a2 infant formula group and the conventional A1/A2 infant formula group. Each group contained 140 infants. The study duration was 56 days.
Primary objective: To compare the growth measurements of the infants fed with the a2 infant formula with those fed with conventional A1/A2 infant formula during the study period. Secondary objectives: To compare the two study groups in 1. Dermatitis quality of life 2. Formula tolerability and acceptability 3. All medically confirmed adverse events The study included four visits at day 0 (baseline), day 14, day 28 and day 56. Information of efficacy outcomes were collected at each visit. Subject diary was used to record tolerance data and daily formula feeding amount during the study. The parents of the participants were also required evaluate their satisfaction with the study formula at the last visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
280
Oral intake of a2 Platinum Premium Infant Formula Stage 1 milk powder (dissolved in water)
Oral intake of Frisolac Infant Formula Step 1 (Dutch Edition) milk power (dissolved in water)
Shanghai Weierkang Pediatric Outpatient Department
Shanghai, China
Body weight measured in gram.
Body weight measured in gram.
Time frame: Baseline, Day 14, Day 28, Day 56
Body length measured in centimeter.
Body length measured in centimeter.
Time frame: Baseline, Day 14, Day 28, Day 56
Head circumference measured in centimeter.
Head circumference measured in centimeter.
Time frame: Baseline, Day 14, Day 28, Day 56
Body mass index calculated from body weight and length.
Body mass index calculated from as weight (kg) dived by the square of body length (meter).
Time frame: Baseline, Day 14, Day 28, Day 56
Weight-for-age Z-score that describe the distance and direction of the weight of a participant away from the mean of the population of the same age
A standard score for measuring weight growth calculated according to the WHO Growth Standards. The weight-for-age Z-score is the distance and direction of the weight of a participant away from the mean body weight of the population of the same age.
Time frame: Baseline, Day 14, Day 28, Day 56
Length-for-age Z-score that describe the distance and direction of the body length of a participant away from the mean body length of the population of the same age
A standard score for measuring body length growth calculated according to the WHO Growth Standards. The length-for-age Z-score is the distance and direction of the body length of a participant away from the mean body length of the population of the same age.
Time frame: Baseline, Day 14, Day 28, Day 56
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BMI-for-age Z-score that describe the distance and direction of the body mass index of a participant away from the mean body mass index of the population of the same age
A standard score for measuring body mass index (BMI) calculated according to the WHO Growth Standards. The BMI-for-age Z-score is the distance and direction of the body mass index of a participant away from the mean body mass index of the population of the same age.
Time frame: Baseline, Day 14, Day 28, Day 56
Head circumference-for-age Z-score that describe the distance and direction of the head circumference of a participant away from the mean head circumference of the population of the same age
A standard score for measuring head circumference calculated according to the WHO Growth Standards. The head circumference-for-age Z-score is the distance and direction of the head circumference of a participant away from the mean head circumference of the population of the same age.
Time frame: Baseline, Day 14, Day 28, Day 56
Weight-for-length Z-score that describe the distance and direction of the weight of a participant away from the mean weight of the population of the same body length
A standard score for measuring weight-for-length growth calculated according to the WHO Growth Standards. The weight-for-length Z-score is the distance and direction of the body weight of a participant away from the mean body weight of the population of the same body length.
Time frame: Baseline, Day 14, Day 28, Day 56
Infants' gastrointestinal symptom score evaluated using the Infant Gastrointestinal Symptom Questionnaire (IGSQ)
The IGSQ score is the sum of 5 domains scores of stooling, spitting up/vomiting, crying, fussiness and flatulence, derived by summing up the relating raw individual scores. Each raw score range from 0 to 5, with higher score indicating more severe gastrointestinal symptoms. Data was collected daily, and the average score during the past week of each visit was used for analyses.
Time frame: Baseline, Day 14, Day 28, Day 56
Number of crying periods evaluated in each 15-minutes period during a day
Number of 15-minute periods at morning, afternoon, evening and night, and the daily total number of crying periods. Data was collected daily, and the average daily number of crying periods during the past week of each visit was used for analyses.
Time frame: Baseline, Day 14, Day 28, Day 56
Infants' Dermatitis Quality of Life Index (IDQoL) that measured participants' quality of life related to dermatitis
An index to evaluate the quality of life related to dermatitis during the past week of each visit. The IDQoL index is the sum of one score for evaluating dermatitis severity (range from 0 to 4 indicating increasing severity from no symptom to very servere symptom) and 10 individual scores (each range from 0 to 3 indicating increasing frequency from none to very often) evaluating the possible problems encountered in daily life due to dermatitis, including itching and scratching, mood, time to get to sleep, sleep disturbance, disturbed playing or swimming, disturbed family activities, problems during meal times, problems from treatment, problems at dressing, and problems at bath time.
Time frame: Baseline, Day 14, Day 28, Day 56
Average daily formula intake amount (ml/day) during the past week measured by formula intake diary
Daily formula intake amount was recorded in ml. The average daily formula intake amount during the past week of each visit was used to assess formula feeding amount.
Time frame: Baseline, Day 14, Day 28, Day 56
Percent of participants with relieved gastrointestinal symptoms by the end of the study, evaluated using the Formula Satisfaction Questionnaire
Parents were required to report whether the gastrointestinal symptoms of the participant have been relieved by the end of the study. Dichotomized variable with 2 levels: Yes or No.
Time frame: Day 56
Percent of participants with relieved skin symptoms by the end of the study, evaluated using the Formula Satisfaction Questionnaire
Parents were required to report whether participant's skin symptoms such as eczema or dermatitis have been relieved by the end of the study. Dichotomized variable with 2 levels: Yes or No.
Time frame: Day 56
Percent of parents of the participants with intention of continuing to feed the child with the study formula, measured in 3 levels: Yes, No, or Not sure using the Formula Satisfaction Questionnaire
Parents were required to indicate their intention of continuing to feed the child with the study formula. Categorical variable with 3 levels: Yes, No, or Not sure.
Time frame: Day 56
Percent of overall satisfaction levels with the study formula, measured in 4 levels: Satisfied, Neutral, Dissatisfied, or Not sure using the Formula Satisfaction Questionnaire
Overall satisfaction with study formula was evaluated by the parents at the end of the study. Category variable with 4 levels: Satisfied, Neutral, Dissatisfied, or Not sure.
Time frame: Day 56