Clinical trial NCT00548106: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Growth Failure
Keywords: infant formula, milk allergy, hydrolized whey
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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

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:

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

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.

Primary outcomes:
measure: Growth parameters, colic and bowel movements parameters.
timeFrame: 3 months
Secondary outcomes:
measure: Side effects
timeFrame: 3 months
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: Head, Pediatric GI and Nutrition Unit
name: Zvi Weizman, MD
role: PRINCIPAL_INVESTIGATOR
References: