Status:
UNKNOWN
The Effect of a New Infant Formula on Growth and Cognition in Healthy Term Infants
Lead Sponsor:
Heilongjiang Feihe Dairy Co. Ltd.
Conditions:
Child Development
Eligibility:
All Genders
30-30 years
Phase:
NA
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 cog...
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. S...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2023
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04508257
Start Date
August 1 2020
End Date
February 28 2023
Last Update
August 18 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Jinhua Nanyuan Community Health Center (site 1919)
Jinhua, Zhejiang, China
2
Jinhua Qiubin Community Health Center (site 1969)
Jinhua, Zhejiang, China
3
Jinhua Xiguan Community Health Center (site 1966)
Jinhua, Zhejiang, China