Growth
Conditions
Brief summary
This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.
Interventions
fed ad libitum
OTHERActive Comparator: Commercially available Infant formula
fed ad libitum
OTHERActive Comparator: Human milk
fed ad libitum
Sponsors
Ausnutria Hyproca B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 13 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy full term infant (37-42 weeks of gestational age) * Birth weight 2,500 to 4,500 g * Infant's mother willing and able to exclusively breast feed or infant's parent(s)/caregiver(s) willing to exclusively use randomized infant formula during study participation * Parent(s)/caregiver(s) able to attend visits and willing to complete the subject diary * Informed consent signed by parent(s)/caregiver(s)
Exclusion criteria
* Congenital illness or malformation that may affect infant feeding or normal growth * Gastrointestinal disorders * Suspected or known allergy to milk protein for formula groups * Known food allergies in parents or siblings for formula groups * Multiples * Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrollment * Infant participating in another clinical study * Infant's family unable to comply with the protocol according to the investigators's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight gain | 16 weeks |
Countries
Austria, Croatia, Germany, Spain
Outcome results
None listed