The Effect of a New Infant Formula on Growth and Cognition in Healthy Term Infants
NCT ID: NCT04508257
Last Updated: 2020-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
450 participants
INTERVENTIONAL
2020-08-01
2023-02-28
Brief Summary
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Detailed Description
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* Compare measures of normal, healthy mental development at 365 days of age among infants receiving an investigational formula, infants receiving the control and breastfed group.
Secondary Objectives
To compare between the two study groups:
* Measures of mental development up to 365 days of age
* Rate of body weight, length and head circumference gain
* Achieved weight, length and head circumference
* Stool characteristics, tolerance and formula acceptance
* Fecal microbiome analysis
* Antibiotic treatment
* Medically-confirmed adverse
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Investigational Formula (Stage 1&2)
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.
Oral feeding of Investigational Formula (Stage 1&2)
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)
Control formula have comparable macronutrients and micronutrients, but does not contain DHA，ARA and MFGM.
Oral feeding of Control formula (Stage 1&2)
Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age.
Breast feeding
Breast fed of human milk
Breast feeding
Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.
Interventions
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Oral feeding of Investigational Formula (Stage 1&2)
Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age.
Oral feeding of Control formula (Stage 1&2)
Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age.
Breast feeding
Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
Additional Criteria for Inclusion in the Stool Collection Subset
* 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
30 Days
30 Days
ALL
Yes
Sponsors
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Heilongjiang Feihe Dairy Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Gong Zhang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Anhui Medical University Affiliated Children's Hospital, China
Locations
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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, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19-SM-09-FEIHE-001
Identifier Type: -
Identifier Source: org_study_id
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