Safety Study of Infant Formula With Partially Hydrolized Whey

Growth Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00548106
• Other study ID #: Sor461707ctil
• Status: Withdrawn
• Phase: N/A
• First received: October 22, 2007
• Last updated: June 13, 2012

Study information

• Verified date: July 2010
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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. 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. 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

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:

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. 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Failure to Thrive
• Growth Failure

Intervention

Dietary Supplement:
• partially hydrolyzed whey
Total infant feeding by study formula.
• Nan HA
Total infant diet by study formula.

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth parameters, colic and bowel movements parameters.		3 months	Yes
Secondary	Side effects		3 months	Yes