Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
- Conditions
- Child Development
- Interventions
- Dietary Supplement: Oral feeding of control Stage 1 formulaDietary Supplement: Oral feeding of Feihe Stage 1 infant formulaDietary Supplement: Breast feeding
- Registration Number
- NCT04013087
- Lead Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
- Brief Summary
This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective study and is intended to evaluate the nutritional adequacy and tolerance of a new study formula compared with a concurrent control formula. Approximately 450 infants will be enrolled from approximately 3 China sites. Of these infants, approximately 300 will be randomized 1:1 to receive an investigational formula or a control formula for 16weeks of feeding. The remaining approximately 150 infants will be enrolled as a breastfeeding reference group. The primary outcome measure is the rate of weight gain in g/day between baseline and 16 weeks in the test group compared to control formula group. Participants will have the option of providing stool samples at 8 weeks and 16 weeks for analysis of microbiota and metabolomics. The study period will be 16 weeks, and all infants in the 2 formula groups will receive formula free of charge for 6 months.
- Detailed Description
Primary Objective
1) Compare the rate of weight gain (in g/day) between infants receiving an investigational formula and infants receiving a control formula between at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
Secondary Objectives
1. Compare rate of change in length (mm/day) among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
2. Compare rate of change in head circumference (mm/day) among infants receiving an investigational formula, infants receiving a control formula and breastfeeding infants at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
3. Evaluate and compare achieved body weight, length, and head circumference at each visit and after 16 weeks.
4. Evaluate plotted raw growth data on World Health Organization standard growth charts.1
5. Compare the types and incidence of adverse events among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
6. Compare average daily intake of formula between infants receiving an investigational formula and infants receiving a control formula.
7. Compare parents' and physician's assessment of formula tolerance among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
8. Compare counts of Bifidobacteria and Lactobacillus species in stools of infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
9. Compare stool short-chain fatty acid metabolites (including total SCFAs, acetic, propionic, n-butyric, iso-butyric and n-valeric acids, L-lactic acid and D-lactic acid, etc) among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 450
- 10-14 days of age at enrolment and randomization, inclusive (day of birth is considered day 0)
- Plan to exclusively formula feed (formula groups) OR exclusively feed human milk (breastfeeding group)
- Healthy singleton birth
- Gestational age of 37-42 completed weeks (37 weeks 0 days through 42 weeks 6 days)
- Birth weight of 2490g to 4200g
- Signed informed consent obtained for infant's and mother's participation in the study
- History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
- Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
- Known allergy to cow's milk protein or a well-documented family history of allergy to cow's milk protein
- Weight at randomization is <90% of birth weight [(weight at Visit 1÷birth weight) x 100 <90%]
- Immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others)
- Known head/brain disease/injury such as microcephaly, macrocephaly or others.
- Enrollment in another interventional clinical research study while participating in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control formula Oral feeding of control Stage 1 formula A commercially available product with comparable composition but does not contain sn-2 palmitate enriched vegetable oil as an ingredient (regular vegetable oil is used) Test Formula Oral feeding of Feihe Stage 1 infant formula Feihe Stage 1 infant formula Breast feeding Breast feeding Breast fed of human milk
- Primary Outcome Measures
Name Time Method Rate of change in body weight (grams/day) from baseline 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks Rate of change in body weight (grams/day) between baseline and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
- Secondary Outcome Measures
Name Time Method Percentage of regurgitation 16 weeks Percentages of parents in each group reporting regurgitation
Fecal Bifidobacteria counts 8 weeks,16 weeks Total fecal Bifidobacteria counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.
Achieved body length 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks Achieved body length (cm) at each study visit
Rate of change in body length (mm/day) from baseline 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks Rate of change in length (mm/day) measured between baseline (B) and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
Percentages of infants in each group who are <10th percentile in head circumference for age. 16 weeks Percentages of infants in each group who are \<10th percentile in head circumference for age.
Percentage of fussiness 16 weeks Percentages of parents in each group reporting fussiness
Achieved head circumference 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks Achieved head circumference (cm) at each study visit
Percentage of patterns 16 weeks Percentages of parents in each group reporting sleeping patterns
Percentage of cramps 16 weeks Percentages of parents in each group reporting cramps
Stool short-chain fatty acid 8 weeks,16 weeks Total stool short-chain fatty acid metabolites in mg/g dry stool at 8 weeks and 16 weeks.
Rate of change in head circumference (mm/day) from baseline 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks Rate of change in head circumference (mm/day) measured between baseline (B) and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
Percentages of infants in each group who are <10th percentile in weight for age. 16 weeks Percentages of infants in each group who are \<10th percentile in weight for age.
Percentage of respiratory manifestations 16 weeks Percentages of parents in each group reporting respiratory manifestations
Percentage of dermatologic manifestations 16 weeks Percentages of parents in each group reporting dermatologic manifestations
Achieved body weight 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks Achieved body weight (grams) at each study visit
Percentages of infants in each group who are <10th percentile in length for age. 16 weeks Percentages of infants in each group who are \<10th percentile in length for age.
Adverse events rate 16 weeks Number and percentages of infants in each group experiencing any adverse events and any serious adverse events
Fecal Lactobacillus counts 8 weeks,16 weeks Total fecal Lactobacillus counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.
Average daily formula intake 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks Average daily formula intake volume based on 3-day records kept by parents or care-givers prior to each study visit.
Percentage of colic 16 weeks Percentages of parents in each group reporting colic
Stool characteristics 16 weeks Score of stool characteristics
Trial Locations
- Locations (3)
Jinhua Qiubin Community Health Center (site 1969)
🇨🇳Jinhua, Zhejiang, China
Jinhua Nanyuan Community Health Center (site 1919)
🇨🇳Jinhua, Zhejiang, China
Jinhua Xiguan Community Health Center (site 1966)
🇨🇳Jinhua, Zhejiang, China