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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Child Development
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
- Enrollment
- 450
- Locations
- 3
- Primary Endpoint
- Infant cognitive development
- Last Updated
- 5 years ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
Infant cognitive development
Time Frame: at 365 days of age
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.
Secondary Outcomes
- Percentage of infants with intramuscular antibiotic treatments(at 365 days of age)
- Ages and Stages Questionnaires (ASQ)(at 120, 180, and 275 days of age)
- Achieve head circumference(at 30, 90, 120, 180, 275, and 365 days of age)
- 24-Hour dietary recall of Formula intake(at 30, 90, 120, 180, 275, and 365 days of age)
- Infant motor skills(at 365 days of age)
- Achieve body weight(at 30, 90, 120, 180, 275, and 365 days of age)
- Percentages of adverse events(from 30 days of age to 365 days of age)
- MacArthur-Bates Communicative Development Inventory（CDI） tests(at 365 days of age)
- Carey Toddler Temperament Scale( TTS )tests(at 365 days of age)
- Infant Language capabilities(at 365 days of age)
- Infant social-emotional capabilities(at 365 days of age)
- Infant adaptive behavior tests(at 365 days of age)
- Infant attention(at 365 days of age)
- Percentage of infants with oral antibiotic treatments(at 365 days of age)
- Achieve body length(at 30, 90, 120, 180, 275, and 365 days of age)
- 24-Hour Recall of Stool Characteristics Questionnaire(at 30, 90, 120, 180, 275, and 365 days of age)
- Stool collection(at enrollment and 120 days of age)
- 24-Hour Recall of Tolerance Questionnaire(at 30, 90, 120, 180, 275, and 365 days of age)
- Percentage of infants with intravenous (IV) antibiotic treatments(at 365 days of age)