Assessment of Growth of Infants Fed a New Formula

Study Overview
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Brief Summary
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The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.

Official Title
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Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin

Conditions
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Infant Nutrition

Intervention / Treatment
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* Other: standard infant formula
* Other: Test 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 Infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment Tolerating a cows milk based formula for at least 3 days Study explained and written information provided with Parent/Caregiver demonstrating understanding of the given information Informed consent signed (Parent/Legal representative) Parent/Caregiver has a working freezer Lives within 45 minutes of a study site 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 enrollment Infant has received oral or intravenous antibiotic therapy in the 10 days prior to enrollment Infant receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements Infant currently participating in another 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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Minimum Age: 11 Days
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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard infant formula<br> | Other: standard infant formula<br>* Standard infant formula given during the first 9 months of life, as per standard requirement<br>|
| Experimental: Test formula<br> | Other: Test formula<br>* Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean weight gain |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anthropometry, tolerance, morbidity, blood tests |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant formula, growth, weight