Status:
UNKNOWN
Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
Lead Sponsor:
Heilongjiang Feihe Dairy Co. Ltd.
Conditions:
Child Development
Eligibility:
All Genders
10-14 years
Phase:
NA
Brief Summary
This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective study and is intended to evaluate the nutritional adequacy and tolerance of a new study formula compar...
Detailed Description
Primary Objective 1\) Compare the rate of weight gain (in g/day) between infants receiving an investigational formula and infants receiving a control formula between at baseline (B), B+2 weeks, B+4 w...
Eligibility Criteria
Inclusion
- 10-14 days of age at enrolment and randomization, inclusive (day of birth is considered day 0)
- Plan to exclusively formula feed (formula groups) OR exclusively feed human milk (breastfeeding group)
- Healthy singleton birth
- Gestational age of 37-42 completed weeks (37 weeks 0 days through 42 weeks 6 days)
- Birth weight of 2490g to 4200g
- Signed informed consent obtained for infant's and mother's participation in the 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)
- Known allergy to cow's milk protein or a well-documented family history of allergy to cow's milk protein
- Weight at randomization is \<90% of birth weight \[(weight at Visit 1÷birth weight) x 100 \<90%\]
- 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)
- Known head/brain disease/injury such as microcephaly, macrocephaly or others.
- Enrollment in another interventional clinical research study while participating in this study
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2020
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04013087
Start Date
July 8 2019
End Date
December 30 2020
Last Update
April 24 2020
Active Locations (3)
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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