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 extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.
Interventions
OTHERExtensively hydrolyzed whey infant formula
New hydrolyzed infant formula.
Commercially available infant formula.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
11 Days to 4 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy newborn singleton infant * Full-term (\>= 37 weeks gestation) * Birth weight between \>= 2500 and \< =4500 g * 14 ± 3 days of age on enrollment * Infant's mother has elected not to breastfeed * baby has been exclusively formula fed a minimum of 3 days prior to enrollment * Study explained and written information provided with Parent/Caregiver * Informed consent signed (parent/legal representative)
Exclusion criteria
* Congenital illness or malformation affecting infant feeding and/or 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 enrollment * Infant has received oral or IV antibiotic therapy in the 10 days prior to enrollment * 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 has received probiotics in the seven days prior to enrollment * Infant currently participating in another 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. |
Countries
United States
Outcome results
None listed