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Safety Study of Infant Formula With Partially Hydrolized Whey

Primary Purpose

Growth Failure

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
partially hydrolyzed whey
Nan HA
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Growth Failure focused on measuring infant formula, milk allergy, hydrolized whey

Eligibility Criteria

1 Day - 30 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Soroka Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Infants will be fed the new hydrolyzate formula.

Nan HA infant formula

Outcomes

Primary Outcome Measures

Growth parameters, colic and bowel movements parameters.

Secondary Outcome Measures

Side effects

Full Information

First Posted
October 22, 2007
Last Updated
June 13, 2012
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00548106
Brief Title
Safety Study of Infant Formula With Partially Hydrolized Whey
Official Title
Evaluation of a New Cow's Milk Infant Formula Containing Partially Hydrolized Whey
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Study withdrawn due to the company decision
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Failure
Keywords
infant formula, milk allergy, hydrolized whey

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Infants will be fed the new hydrolyzate formula.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Nan HA infant formula
Intervention Type
Dietary Supplement
Intervention Name(s)
partially hydrolyzed whey
Other Intervention Name(s)
Other names are not available yet.
Intervention Description
Total infant feeding by study formula.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nan HA
Other Intervention Name(s)
Not available yet.
Intervention Description
Total infant diet by study formula.
Primary Outcome Measure Information:
Title
Growth parameters, colic and bowel movements parameters.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Side effects
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zvi Weizman, MD
Organizational Affiliation
Head, Pediatric GI and Nutrition Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Safety Study of Infant Formula With Partially Hydrolized Whey

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