Study of Nutritional Suitability of a New Infant Formula for Term Infants
Not Applicable
Completed
- Conditions
- Growth
- Interventions
- Other: Investigational infant formula
- Registration Number
- NCT02490852
- Lead Sponsor
- Ausnutria Hyproca B.V.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Investigational Infant formula Investigational infant formula Healthy term infants fed exclusively the investigational Infant Formula
- Primary Outcome Measures
Name Time Method Weight gain 16 weeks
- Secondary Outcome Measures
Name Time Method