Clinical trial NCT04508257: The Effect of a New Infant Formula on Growth and Cognition in Healthy Term Infants
Official title: Randomized, Double-blind, Parallel, Controlled Study to Evaluate the Nutritive Effects of Two Staged Infant Formulas on Growth and Cognitive Outcomes in Healthy Term Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Development
Lead sponsor: Heilongjiang Feihe Dairy Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-11
Enrollment: 450
Sex: ALL
Minimum age (years): 30
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Primary Objective

* 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

Eligibility criteria: Inclusion Criteria:

* 30 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

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)
* 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

Primary outcomes:
measure: Infant cognitive development
timeFrame: at 365 days of age
Secondary outcomes:
measure: Infant Language capabilities
timeFrame: at 365 days of age
measure: Infant motor skills
timeFrame: at 365 days of age
measure: Infant social-emotional capabilities
timeFrame: at 365 days of age
measure: Infant adaptive behavior tests
timeFrame: at 365 days of age
measure: Ages and Stages Questionnaires (ASQ)
timeFrame: at 120, 180, and 275 days of age
measure: MacArthur-Bates Communicative Development Inventory（CDI） tests
timeFrame: at 365 days of age
measure: Carey Toddler Temperament Scale( TTS )tests
timeFrame: at 365 days of age
measure: Infant attention
timeFrame: at 365 days of age
measure: Achieve body weight
timeFrame: at 30, 90, 120, 180, 275, and 365 days of age
measure: Achieve body length
timeFrame: at 30, 90, 120, 180, 275, and 365 days of age
measure: Achieve head circumference
timeFrame: at 30, 90, 120, 180, 275, and 365 days of age
measure: 24-Hour dietary recall of Formula intake
timeFrame: at 30, 90, 120, 180, 275, and 365 days of age
measure: 24-Hour Recall of Stool Characteristics Questionnaire
timeFrame: at 30, 90, 120, 180, 275, and 365 days of age
measure: 24-Hour Recall of Tolerance Questionnaire
timeFrame: at 30, 90, 120, 180, 275, and 365 days of age
measure: Percentages of adverse events
timeFrame: from 30 days of age to 365 days of age
measure: Stool collection
timeFrame: at enrollment and 120 days of age
measure: Percentage of infants with oral antibiotic treatments
timeFrame: at 365 days of age
measure: Percentage of infants with intramuscular antibiotic treatments
timeFrame: at 365 days of age
measure: Percentage of infants with intravenous (IV) antibiotic treatments
timeFrame: at 365 days of age
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Jinhua Nanyuan Community Health Center (site 1919)
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Qiubin Community Health Center (site 1969)
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Xiguan Community Health Center (site 1966)
state: Zhejiang
Study officials:
affiliation: Anhui Medical University Affiliated Children's Hospital, China
name: Gong Zhang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: