Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants

Randomized, Double-blind, Parallel, Controlled Study to Evaluate the Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants

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.

Study Overview

• Status: Unknown
• Conditions: Child Development
• Intervention / Treatment: Dietary supplement: Oral feeding of Feihe Stage 1 infant formula; Dietary supplement: Oral feeding of control Stage 1 formula; Dietary supplement: Breast feeding

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.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Jinhua, Zhejiang, China
      • Jinhua Nanyuan Community Health Center (site 1919)
    • Jinhua, Zhejiang, China
      • Jinhua Qiubin Community Health Center (site 1969)
    • Jinhua, Zhejiang, China
      • Jinhua Xiguan Community Health Center (site 1966)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Formula; Feihe Stage 1 infant formula	Dietary supplement: Oral feeding of Feihe Stage 1 infant formula; Oral feeding of Feihe Stage 1 infant formula for 16 weeks
Active Comparator: Control 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)	Dietary supplement: Oral 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))
Other: Breast feeding; Breast fed of human milk	Dietary supplement: Breast feeding; Breast feeding of human milk for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of change in body weight (grams/day) from baseline	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.	2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of change in body length (mm/day) from baseline	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.	2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Rate of change in head circumference (mm/day) from baseline	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.	2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved body weight	Achieved body weight (grams) at each study visit	2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved body length	Achieved body length (cm) at each study visit	2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved head circumference	Achieved head circumference (cm) at each study visit	2 weeks, 4 weeks, 8 weeks, 12 weeks, 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 weight 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 length for age.	16 weeks
Percentages of infants in each group who are <10th percentile in head circumference for age.	Percentages of infants in each group who are <10th percentile in head circumference for age.	16 weeks
Adverse events rate	Number and percentages of infants in each group experiencing any adverse events and any serious adverse events	16 weeks
Average daily formula intake	Average daily formula intake volume based on 3-day records kept by parents or care-givers prior to each study visit.	2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Percentage of fussiness	Percentages of parents in each group reporting fussiness	16 weeks
Percentage of colic	Percentages of parents in each group reporting colic	16 weeks
Percentage of patterns	Percentages of parents in each group reporting sleeping patterns	16 weeks
Percentage of cramps	Percentages of parents in each group reporting cramps	16 weeks
Percentage of regurgitation	Percentages of parents in each group reporting regurgitation	16 weeks
Stool characteristics	Score of stool characteristics	16 weeks
Percentage of respiratory manifestations	Percentages of parents in each group reporting respiratory manifestations	16 weeks
Percentage of dermatologic manifestations	Percentages of parents in each group reporting dermatologic manifestations	16 weeks
Fecal Bifidobacteria counts	Total fecal Bifidobacteria counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.	8 weeks,16 weeks
Fecal Lactobacillus counts	Total fecal Lactobacillus counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.	8 weeks,16 weeks
Stool short-chain fatty acid	Total stool short-chain fatty acid metabolites in mg/g dry stool at 8 weeks and 16 weeks.	8 weeks,16 weeks

Collaborators and Investigators

• Sponsor: Heilongjiang Feihe Dairy Co. Ltd.
• Investigators: Principal Investigator: Fei Li, PhD, Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): April 19, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 18-SM-12-FEIHE-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No