NCT00548106

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:

  1. 1.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.
  2. 2.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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
Last Updated

June 14, 2012

Status Verified

July 1, 2010

First QC Date

October 22, 2007

Last Update Submit

June 13, 2012

Conditions

Growth Failure

Keywords

infant formula, milk allergy, hydrolized whey

Outcome Measures

Primary Outcomes (1)

  • Growth parameters, colic and bowel movements parameters.

    3 months

Secondary Outcomes (1)

  • Side effects

    3 months

Study Arms (2)

1

EXPERIMENTAL

Infants will be fed the new hydrolyzate formula.

Dietary Supplement: partially hydrolyzed whey

2

PLACEBO COMPARATOR

Nan HA infant formula

Dietary Supplement: partially hydrolyzed wheyDietary Supplement: Nan HA

Interventions

partially hydrolyzed wheyDIETARY_SUPPLEMENT

Total infant feeding by study formula.

Also known as: Other names are not available yet.
12
Nan HADIETARY_SUPPLEMENT

Total infant diet by study formula.

Also known as: Not available yet.
2

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy term neonates whose mothers are not able or choose not to breastfeed for medical, social, or personal reasons, will be recruited

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Medical Center

Beersheba, 84101, Israel

Location

MeSH Terms

Conditions

Failure to ThriveMilk Hypersensitivity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsFood HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Zvi Weizman, MD

    Head, Pediatric GI and Nutrition Unit

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2007

First Posted

October 23, 2007

Last Updated

June 14, 2012

Record last verified: 2010-07

Locations

IL(1)