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

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04013087
• Other study ID #: 18-SM-12-FEIHE-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2020
• Source: Heilongjiang Feihe Dairy Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: December 30, 2020
• Est. primary completion date: April 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Child Development

Intervention

Dietary Supplement:
• Oral feeding of Feihe Stage 1 infant formula
Oral feeding of Feihe Stage 1 infant formula for 16 weeks
• 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))
• Breast feeding
Breast feeding of human milk for 16 weeks

Locations

Country	Name	City	State
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)	Jinhua	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang Feihe Dairy Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Achieved body weight	Achieved body weight (grams) at each study visit	2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary	Achieved body length	Achieved body length (cm) at each study visit	2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary	Achieved head circumference	Achieved head circumference (cm) at each study visit	2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events rate	Number and percentages of infants in each group experiencing any adverse events and any serious adverse events	16 weeks
Secondary	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
Secondary	Percentage of fussiness	Percentages of parents in each group reporting fussiness	16 weeks
Secondary	Percentage of colic	Percentages of parents in each group reporting colic	16 weeks
Secondary	Percentage of patterns	Percentages of parents in each group reporting sleeping patterns	16 weeks
Secondary	Percentage of cramps	Percentages of parents in each group reporting cramps	16 weeks
Secondary	Percentage of regurgitation	Percentages of parents in each group reporting regurgitation	16 weeks
Secondary	Stool characteristics	Score of stool characteristics	16 weeks
Secondary	Percentage of respiratory manifestations	Percentages of parents in each group reporting respiratory manifestations	16 weeks
Secondary	Percentage of dermatologic manifestations	Percentages of parents in each group reporting dermatologic manifestations	16 weeks
Secondary	Fecal Bifidobacteria counts	Total fecal Bifidobacteria counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.	8 weeks,16 weeks
Secondary	Fecal Lactobacillus counts	Total fecal Lactobacillus counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.	8 weeks,16 weeks
Secondary	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