Study of Nutritional Suitability of a New Infant Formula for Term Infants

Ausnutria Hyproca B.V.0 sites304 target enrollmentAugust 2015

ConditionsGrowth

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth
Sponsor: Ausnutria Hyproca B.V.
Enrollment: 304
Primary Endpoint: Weight gain
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

August 22, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ausnutria Hyproca B.V.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy full term infant (37-42 weeks of gestational age)
•Birth weight 2,500 to 4,500 g
•Infant's mother willing and able to exclusively breast feed or infant's parent(s)/caregiver(s) willing to exclusively use randomized infant formula during study participation
•Parent(s)/caregiver(s) able to attend visits and willing to complete the subject diary
•Informed consent signed by parent(s)/caregiver(s)

Exclusion Criteria

•Congenital illness or malformation that may affect infant feeding or normal growth
•Gastrointestinal disorders
•Suspected or known allergy to milk protein for formula groups
•Known food allergies in parents or siblings for formula groups
•Multiples
•Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrollment
•Infant participating in another clinical study
•Infant's family unable to comply with the protocol according to the investigators's assessment