Growth of Infants Fed an Extensively Hydrolyzed Infant Formula

Nestlé

Status

Completed

Conditions

Growth

Treatments

Other: Extensively hydrolyzed casein infant formula

Other: Extensively hydrolyzed whey infant formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT01210391

09.43.PED

Details and patient eligibility

About

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.

Enrollment

282 patients

Sex

All

Ages

11 days to 4 months old

Volunteers

Accepts Healthy Volunteers

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