Healthy Growth
Conditions
Keywords
infant formula, human milk oligosaccharide, HMO, growth
Brief summary
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.
Interventions
Standard infant formula
OTHERInfant formula supplemented with HMO
Infant formula supplemented with HMO
Sponsors
FrieslandCampina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
Yes
Inclusion criteria
* Gestational age ≥ 37 weeks * Birth weight ≥ 2500 grams * No recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases) * Boys and girls * Recruited \< 1 month/age * Being available for follow up until the age of 4 months * Exclusive formula feeding or exclusive breast feeding at time of recruitment
Exclusion criteria
* Gestational age \<37 weeks * Birth weight \<2500 grams * Severe acquired or congenital diseases, mental or physical disorders * Illness at screening/ inclusion * Incapability of parents/caregivers to comply with the study protocol * Received antibiotics within the first month of life * Not tolerating standard cow's milk based infant formula * Participation in another clinical trial * Maternal illicit drug use during pregnancy or post-partum period * Parent/caregiver does not have a cell phone to use for filling out questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth | From enrollment until end of the 3 month-study | Infant growth measured as body weight gain per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recumbent length | Monthly, from enrollment until end of the 3 month-study | Infant length (cm and cm/day) |
| Head circumference | Monthly, from enrollment until end of the 3 month-study | Head circumference (cm and cm/day) |
| Weight | Monthly, from enrollment until end of the 3 month-study | Infant weight (kg) |
| Formula tolerance | Monthly, from enrollment until end of the 3 month-study | Parents are asked to keep a diary on formula intake 3 days prior to each monthly study visit |
| Gastro-intestinal comfort | Monthly, from enrollment until end of the 3 month-study | 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 |
| Anthropometry z-scores | Monthly, from enrollment until end of the 3 month-study | World Health Organization (WHO) growth standard calculated z-scores for weight, length, weight-for-length and head circumference |
Countries
United States
Outcome results
None listed