Growth of Infants Fed an Amino Acid Infant Formula

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Growth of Infants Fed an Amino Acid Based Formula

Conditions
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Growth

Intervention / Treatment
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* Other: Amino Acid Formula
* Other: Amino Acid formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amino Acid Formula<br>Hypoallergenic baby formula | Other: Amino Acid Formula<br>* Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula<br>|
| Active Comparator: Amino Acid commercial formula<br>Hypoallergenic commercial amino acid formula | Other: Amino Acid formula<br>* Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Gain | Mean weight gain (g/day) from enrollment to 4 months of age | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tolerance | Tolerance will be evaluated based on formula intake, stool characteristics, vomiting/spitting up and behavior from enrollment to 4 months. | 4 months |