Clinical trial NCT04013087: Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
Official title: Randomized, Double-blind, Parallel, Controlled Study to Evaluate the Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Development
Lead sponsor: Heilongjiang Feihe Dairy Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2019-07-09
Enrollment: 450
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of change in body weight (grams/day) from baseline
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary outcomes:
measure: Rate of change in body length (mm/day) from baseline
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
measure: Rate of change in head circumference (mm/day) from baseline
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
measure: Achieved body weight
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
measure: Achieved body length
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
measure: Achieved head circumference
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
measure: Percentages of infants in each group who are <10th percentile in weight for age.
timeFrame: 16 weeks
measure: Percentages of infants in each group who are <10th percentile in length for age.
timeFrame: 16 weeks
measure: Percentages of infants in each group who are <10th percentile in head circumference for age.
timeFrame: 16 weeks
measure: Adverse events rate
timeFrame: 16 weeks
measure: Average daily formula intake
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
measure: Percentage of fussiness
timeFrame: 16 weeks
measure: Percentage of colic
timeFrame: 16 weeks
measure: Percentage of patterns
timeFrame: 16 weeks
measure: Percentage of cramps
timeFrame: 16 weeks
measure: Percentage of regurgitation
timeFrame: 16 weeks
measure: Stool characteristics
timeFrame: 16 weeks
measure: Percentage of respiratory manifestations
timeFrame: 16 weeks
measure: Percentage of dermatologic manifestations
timeFrame: 16 weeks
measure: Fecal Bifidobacteria counts
timeFrame: 8 weeks,16 weeks
measure: Fecal Lactobacillus counts
timeFrame: 8 weeks,16 weeks
measure: Stool short-chain fatty acid
timeFrame: 8 weeks,16 weeks
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Jinhua Nanyuan Community Health Center (site 1919)
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Qiubin Community Health Center (site 1969)
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Xiguan Community Health Center (site 1966)
state: Zhejiang
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Fei Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: