Growth of Infants Fed an Amino Acid Infant Formula

Nestlé

Status

Completed

Conditions

Growth

Treatments

Other: Amino Acid formula

Other: Amino Acid Formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT01583673

09.56.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 Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period of 4 months.

Enrollment

225 patients

Sex

All

Ages

Under 17 days old

Volunteers

Accepts Healthy Volunteers

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