Child Development
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOral feeding of Feihe Stage 1 infant formula
Oral feeding of Feihe Stage 1 infant formula for 16 weeks
DIETARY_SUPPLEMENTOral feeding of control Stage 1 formula
Oral feeding of control Stage 1 formula for 16 weeks (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))
DIETARY_SUPPLEMENTBreast feeding
Breast feeding of human milk for 16 weeks
Sponsors
Heilongjiang Feihe Dairy Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Achieved body weight | 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks | Achieved body weight (grams) at each study visit |
| Achieved body length | 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks | Achieved body length (cm) at each study visit |
| Achieved head circumference | 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks | Achieved head circumference (cm) at each study visit |
| 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. |
| 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. |
| 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. |
| Adverse events rate | 16 weeks | Number and percentages of infants in each group experiencing any adverse events and any serious adverse events |
| 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 fussiness | 16 weeks | Percentages of parents in each group reporting fussiness |
| 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. |
| 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 |
| Percentage of regurgitation | 16 weeks | Percentages of parents in each group reporting regurgitation |
| Stool characteristics | 16 weeks | Score of stool characteristics |
| 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 |
| Fecal Bifidobacteria counts | 8 weeks,16 weeks | Total fecal Bifidobacteria counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks. |
| Fecal Lactobacillus counts | 8 weeks,16 weeks | Total fecal Lactobacillus counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks. |
| 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. |
| Percentage of colic | 16 weeks | Percentages of parents in each group reporting colic |
Countries
China
Outcome results
None listed