The Effect of a New Infant Formula on Growth and Cognition in Healthy Term Infants

NCT04508257 | Unknown DMC

• 1 other identifier: 19-SM-09-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 trial and is intended to evaluate the nutritive effects of two staged study formulas on growth and cognitive outcomes. Approximately 450 participants will be enrolled with the expectation of having 105 participants per group (315 for three groups: control group, investigational group, and breastfeeding reference group ) complete Study Visit 6 at 365 days of age ± 7 days (allowing for a 30% drop-out rate). Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age. The study period will include feeding up to 365 days of age and cognitive testing up to 365 days of age. Stool samples will be collected from a subset of participants at enrollment and at 120 days of age for fecal microbiome analysis.

Conditions

Child Development

Outcome Measures

Primary Outcomes (1)

• Infant cognitive development

  Cognitive Scale of the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is used to evaluate infant cognitive development at 365 days of age. 1. Unabbreviated scale title： Bayley-III Scales of Infant Development Tables and Graphs Report-- Cognitive Scale ； 2. Bayley-III contains two scoring systems of composite scores and percentile ranks. The normal range for composite scores is between 40-160 with mean at 100 and 0-99 for the percentile ranks. 3. Higher scores mean a better outcome.

  at 365 days of age

Secondary Outcomes (19)

• Infant Language capabilities

  at 365 days of age

• Infant motor skills

  at 365 days of age

• Infant social-emotional capabilities

  at 365 days of age

• Infant adaptive behavior tests

  at 365 days of age

• Ages and Stages Questionnaires (ASQ)

  at 120, 180, and 275 days of age

Study Arms (3)

Investigational Formula (Stage 1&2)

EXPERIMENTAL

Investigational formula contains DHA，ARA and enriched whey protein (source of milk fat globule membrane) to support the healthy growth and Cognitive development of infants.

Dietary Supplement: Oral feeding of Investigational Formula (Stage 1&2)

Control formula (Stage 1&2)

ACTIVE COMPARATOR

Control formula have comparable macronutrients and micronutrients, but does not contain DHA，ARA and MFGM.

Dietary Supplement: Oral feeding of Control formula (Stage 1&2)

Breast feeding

OTHER

Breast fed of human milk

Dietary Supplement: Breast feeding

Interventions

Oral feeding of Investigational Formula (Stage 1&2) DIETARY_SUPPLEMENT

Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age.

Investigational Formula (Stage 1&2)

Oral feeding of Control formula (Stage 1&2) DIETARY_SUPPLEMENT

Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age.

Control formula (Stage 1&2)

Breast feeding DIETARY_SUPPLEMENT

Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.

Breast feeding

Eligibility Criteria

• Age: 30 Days - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• days of age at randomization, inclusive (day of birth is considered day 0)
• Exclusively formula-fed for at least 3 days prior to randomization
• Singleton birth
• Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
• Birth weight of 2500g to 4000g
• Signed informed consent obtained for infant's participation in the study
• Parent or guardian of infant agrees not to enroll infant in another interventional clinical research study while participating in this 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)
• Weight at Visit 1 is \<95% of birth weight \[(weight at Visit 1÷birth weight) x 100 \<95%\]
• Infant is 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) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others.
• 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)
• Weight at Visit 1 is \<95% of birth weight \[(weight at Visit 1÷birth weight) x 100 \<95%\]
• Infant is 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) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others.
• Vaginal birth
• Participant has not received antibiotic treatment antibiotic and/or corticosteroid treatment for at least 30 days prior to the collection.
• Participant has not consumed prebiotics/probiotics supplements
• Parent/caregiver has access to a home freezer for sample storage

Sponsors & Collaborators

• Heilongjiang Feihe Dairy Co. Ltd.: lead

Study Sites (3)

Jinhua Nanyuan Community Health Center (site 1919)

Jinhua, Zhejiang, China

RECRUITING

Jinhua Qiubin Community Health Center (site 1969)

Jinhua, Zhejiang, China

RECRUITING

Jinhua Xiguan Community Health Center (site 1966)

Jinhua, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

Lactation

Intervention Hierarchy (Ancestors)

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

Study Officials

• Gong Zhang, M.D., Ph.D.

  Anhui Medical University Affiliated Children's Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, MD

CONTACT

+86 21 51097272; charlie.zhang@sprim.cn

Wei Zhang, PhD

CONTACT

+86 10 8457 4688; zhangwei1@feihe.com

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: August 2, 2020
• First Posted: August 11, 2020
• Study Start: August 1, 2020
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

CN (3)