Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.

Société des Produits Nestlé (SPN)19 sites in 1 country282 target enrollmentNovember 2010

ConditionsGrowth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 282
Locations: 19
Primary Endpoint: Weight Gain
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

July 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

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