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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-08-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Investigational Infant formula

Healthy term infants fed exclusively the investigational Infant Formula

Group Type EXPERIMENTAL

Investigational infant formula

Intervention Type OTHER

fed ad libitum

Commercially available Infant formula

Healthy term infants fed exclusively a commercially available Infant Formula

Group Type ACTIVE_COMPARATOR

Active Comparator: Commercially available Infant formula

Intervention Type OTHER

fed ad libitum

Human milk

Healthy term infants fed exclusively human milk

Group Type ACTIVE_COMPARATOR

Active Comparator: Human milk

Intervention Type OTHER

fed ad libitum

Interventions

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Investigational infant formula

fed ad libitum

Intervention Type OTHER

Active Comparator: Commercially available Infant formula

fed ad libitum

Intervention Type OTHER

Active Comparator: Human milk

fed ad libitum

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

13 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes