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

Ausnutria Hyproca

Status: Completed

Conditions: Growth

Treatments: Other: Active Comparator: Human milk; Other: Investigational infant formula; Other: Active Comparator: Commercially available Infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02490852

AUS/015513

Details and patient eligibility

About

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.

Enrollment: 304 patients

Sex: All

Ages: Under 13 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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304 participants in 3 patient groups

Investigational Infant formula

Experimental group

Description:

Healthy term infants fed exclusively the investigational Infant Formula

Treatment:

Other: Investigational infant formula

Commercially available Infant formula

Active Comparator group

Description:

Healthy term infants fed exclusively a commercially available Infant Formula

Treatment:

Other: Active Comparator: Commercially available Infant formula

Human milk

Active Comparator group

Description:

Healthy term infants fed exclusively human milk

Treatment:

Other: Active Comparator: Human milk