The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
265
Standard infant formula
Infant formula supplemented with HMO
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Growth
Infant growth measured as body weight gain per day
Time frame: From enrollment until end of the 3 month-study
Weight
Infant weight (kg)
Time frame: Monthly, from enrollment until end of the 3 month-study
Recumbent length
Infant length (cm and cm/day)
Time frame: Monthly, from enrollment until end of the 3 month-study
Head circumference
Head circumference (cm and cm/day)
Time frame: Monthly, from enrollment until end of the 3 month-study
Anthropometry z-scores
World Health Organization (WHO) growth standard calculated z-scores for weight, length, weight-for-length and head circumference
Time frame: Monthly, from enrollment until end of the 3 month-study
Formula tolerance
Parents are asked to keep a diary on formula intake 3 days prior to each monthly study visit
Time frame: Monthly, from enrollment until end of the 3 month-study
Gastro-intestinal comfort
Parents are asked to keep a diary 3 days prior to each monthly study visit including questions on gastro-intestinal symptoms (e.g. cramps, constipation, vomiting) and crying behavior
Time frame: Monthly, from enrollment until end of the 3 month-study
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