Safety Study of Infant Formula With Partially Hydrolized Whey

Study Overview
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Brief Summary
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The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving. The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age. There will be two study groups, each receiving one of the following formulas: The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot. The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color

Detailed Description
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The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving. The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age. There will be two study groups, each receiving one of the following formulas: The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot. The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color

Official Title
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Evaluation of a New Cow's Milk Infant Formula Containing Partially Hydrolized Whey

Conditions
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Growth Failure

Intervention / Treatment
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* Dietary Supplement: partially hydrolyzed whey
* Dietary Supplement: Nan HA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy term neonates whose mothers are not able or choose not to breastfeed for medical, social, or personal reasons, will be recruited Exclusion Criteria: Twins Premature or low birth weight (< 2500 g). Chromosomal abnormalities or congenital malformations. Jaundice of more than 12 mg% and/or phototherapy. Treatment with antibiotics or other drugs during the last three days or more prior to the commencement of the study.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Infants will be fed the new hydrolyzate formula. | Dietary Supplement: partially hydrolyzed whey<br>* Total infant feeding by study formula.<br>* Other names: Other names are not available yet.;|
| Placebo Comparator: 2<br>Nan HA infant formula | Dietary Supplement: partially hydrolyzed whey<br>* Total infant feeding by study formula.<br>* Other names: Other names are not available yet.;Dietary Supplement: Nan HA<br>* Total infant diet by study formula.<br>* Other names: Not available yet.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth parameters, colic and bowel movements parameters. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant formula, milk allergy, hydrolized whey