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

NCT04013087 | Unknown DMC

• 1 other identifier: 18-SM-12-FEIHE-001
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 3

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.

Conditions

Child Development

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Rate of change in body length (mm/day) from baseline

  2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks

• Rate of change in head circumference (mm/day) from baseline

  2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks

• Achieved body weight

  2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks

• Achieved body length

  2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks

• Achieved head circumference

  2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Study Arms (3)

Test Formula

EXPERIMENTAL

Feihe Stage 1 infant formula

Dietary Supplement: Oral feeding of Feihe Stage 1 infant formula

Control formula

ACTIVE COMPARATOR

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

Breast feeding

OTHER

Breast fed of human milk

Dietary Supplement: Breast feeding

Interventions

Oral feeding of Feihe Stage 1 infant formula DIETARY_SUPPLEMENT

Oral feeding of Feihe Stage 1 infant formula for 16 weeks

Test Formula

Oral feeding of control Stage 1 formula DIETARY_SUPPLEMENT

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))

Control formula

Breast feeding DIETARY_SUPPLEMENT

Breast feeding of human milk for 16 weeks

Breast feeding

Eligibility Criteria

• Age: 10 Days - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heilongjiang Feihe Dairy Co. Ltd.: lead

Study Sites (3)

Jinhua Nanyuan Community Health Center (site 1919)

Jinhua, Zhejiang, China

Location

Jinhua Qiubin Community Health Center (site 1969)

Jinhua, Zhejiang, China

Location

Jinhua Xiguan Community Health Center (site 1966)

Jinhua, Zhejiang, China

Location

MeSH Terms

Interventions

Lactation

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Fei Li, PhD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 9, 2019
• Study Start: July 8, 2019
• Primary Completion: April 19, 2020
• Study Completion: December 30, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

CN (3)