- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04508257
The Effect of a New Infant Formula on Growth and Cognition in Healthy Term Infants
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 Overview
Status
Conditions
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Li Zhang, MD
- Phone Number: +86 21 51097272
- Email: charlie.zhang@sprim.cn
Study Locations
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-
Zhejiang
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Jinhua, Zhejiang, China
- Recruiting
- Jinhua Nanyuan Community Health Center (site 1919)
-
Contact:
- Melody Hou
- Phone Number: +86 133 2198 2383
- Email: 13321982383@163.com
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Jinhua, Zhejiang, China
- Recruiting
- Jinhua Qiubin Community Health Center (site 1969)
-
Contact:
- Melody Hou
- Phone Number: +86 133 2198 2383
- Email: 13321982383@163.com
-
Jinhua, Zhejiang, China
- Recruiting
- Jinhua Xiguan Community Health Center (site 1966)
-
Contact:
- Melody Hou
- Phone Number: +86 133 2198 2383
- Email: 13321982383@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age.
|
ACTIVE_COMPARATOR: Control formula (Stage 1&2)
Control formula have comparable macronutrients and micronutrients, but does not contain DHA,ARA and MFGM.
|
Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age.
|
OTHER: Breast feeding
Breast fed of human milk
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Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at 365 days of age
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant Language capabilities
Time Frame: at 365 days of age
|
Language Scale of Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is used to evaluate the infant Language capabilities at 365 days of age.
|
at 365 days of age
|
Infant motor skills
Time Frame: at 365 days of age
|
Motor Scale of Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is used to evaluate the infant motor skills at 365 days of age.
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at 365 days of age
|
Infant social-emotional capabilities
Time Frame: at 365 days of age
|
Social-emotional Scale of Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is used to evaluate the infant social-emotional capabilities at 365 days of age.
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at 365 days of age
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Infant adaptive behavior tests
Time Frame: at 365 days of age
|
Adaptive behavior Scale of Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is used as the infant adaptive behavior assessment tool at 365 days of age.
|
at 365 days of age
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Ages and Stages Questionnaires (ASQ)
Time Frame: at 120, 180, and 275 days of age
|
Ages and Stages Questionnaires (ASQ) is administered at 120, 180, and 275 days of age. ASQ is a developmental screening system comprised of age-specific questionnaires which measure 5 domains of infant development.
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at 120, 180, and 275 days of age
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MacArthur-Bates Communicative Development Inventory(CDI) tests
Time Frame: at 365 days of age
|
MacArthur-Bates Communicative Development Inventory (CDI) tests is administered at 365 days of age. It is a parent-report measure that has been validated against actual child language diaries.
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at 365 days of age
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Carey Toddler Temperament Scale( TTS )tests
Time Frame: at 365 days of age
|
Carey Toddler Temperament Scale (TTS) tests is administered at 365 days of age. TTS is a 97-item questionnaire which measures the nine categories of temperament: activity level, regularity, adaptability, approach-withdrawal, intensity, mood, persistence, sensory threshold and distractibility.
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at 365 days of age
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Infant attention
Time Frame: at 365 days of age
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Single object attention and free play tasks is used to measure the infant's attention capabilities.
The tasks assess overall fixation (attention) and looking away (inattention) in regards to novel and familiar objects.
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at 365 days of age
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Achieve body weight
Time Frame: at 30, 90, 120, 180, 275, and 365 days of age
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Achieve body weight (grams) of infants and toddlers at each study visit
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at 30, 90, 120, 180, 275, and 365 days of age
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Achieve body length
Time Frame: at 30, 90, 120, 180, 275, and 365 days of age
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Achieve body length (cm) of infants and toddlers at each study visit
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at 30, 90, 120, 180, 275, and 365 days of age
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Achieve head circumference
Time Frame: at 30, 90, 120, 180, 275, and 365 days of age
|
Achieve head circumference (cm) of infants and toddlers at each study visit
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at 30, 90, 120, 180, 275, and 365 days of age
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24-Hour dietary recall of Formula intake
Time Frame: at 30, 90, 120, 180, 275, and 365 days of age
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The parent/caregiver need to record the amount of study formula consumed as well as any other infant formula or milk consumed since the last study visit
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at 30, 90, 120, 180, 275, and 365 days of age
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24-Hour Recall of Stool Characteristics Questionnaire
Time Frame: at 30, 90, 120, 180, 275, and 365 days of age
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The parent/caregiver will also be asked to recall the number of bowel movements and the stool consistency seen most often over the 24-hour period. Pictures will be provided to the participant's parent or caregiver for use as a guide in rating the stool consistency. Questionnaire: What stool consistency was seen most often in your baby's bowel movements over the past 24 hours?(Use pictures provided for reference) (0) No bowel movement;
For option 0~5, 0 and 1 represent poor stool Characteristics , 2-5 represent fine stool Characteristics. |
at 30, 90, 120, 180, 275, and 365 days of age
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24-Hour Recall of Tolerance Questionnaire
Time Frame: at 30, 90, 120, 180, 275, and 365 days of age
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Tolerance information concerning how fussy and gassy the infant has been and if the infant has been more fussy and/or gassy than normal need to be recalled and recorded by parent/caregiver for the 24-hour period prior to the study visit. Questionnaire:
For Question 1 ~ 4, the lower the score, the better. |
at 30, 90, 120, 180, 275, and 365 days of age
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Percentages of adverse events
Time Frame: from 30 days of age to 365 days of age
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Number and percentages of infants in each group experiencing any medically-confirmed adverse events and any serious adverse events.
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from 30 days of age to 365 days of age
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Stool collection
Time Frame: at enrollment and 120 days of age
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Fecal microbiome analysis of samples collected at enrollment and at 120 days of age
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at enrollment and 120 days of age
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Percentage of infants with oral antibiotic treatments
Time Frame: at 365 days of age
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Percentage(%) of infants in each group using any oral antibiotic treatments.
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at 365 days of age
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Percentage of infants with intramuscular antibiotic treatments
Time Frame: at 365 days of age
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Percentage(%) of infants in each group using intramuscular antibiotic treatments.
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at 365 days of age
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Percentage of infants with intravenous (IV) antibiotic treatments
Time Frame: at 365 days of age
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Percentage(%) of infants in each group using intravenous (IV) antibiotic treatments.
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at 365 days of age
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Collaborators and Investigators
Investigators
- Principal Investigator: Gong Zhang, M.D., Ph.D., Anhui Medical University Affiliated Children's Hospital, China
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19-SM-09-FEIHE-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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