Growth
Conditions
Brief summary
The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period of 4 months.
Interventions
OTHERAmino Acid Formula
Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula
OTHERAmino Acid formula
Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy newborn infant * Full-term (\>= 37 weeks gestation) * Birth weight between \>= 2500 and \< =4500 g * 0-17 days of age on enrolment (day 0 is day of birth) * Infant's mother has elected not to breastfeed and to exclusively formula-feed infant * Study explained and written information provided with Caregiver demonstrating understanding of the given information * Informed consent signed (parent/legal representative)
Exclusion criteria
* Congenital illness or malformation that may affect infant feeding and/or normal growth * Suspected or known allergy to cow's milk protein * Significant pre-natal and/or post-natal disease * Any readmission to hospital (except for hyperbilirubinemia) prior to enrolment * Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements * Infant currently participating in another conflicting clinical study * Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Gain | 4 months | Mean weight gain (g/day) from enrollment to 4 months of age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tolerance | 4 months | Tolerance will be evaluated based on formula intake, stool characteristics, vomiting/spitting up and behavior from enrollment to 4 months. |
Countries
United States
Outcome results
None listed