Safety Study of Infant Formula With Partially Hydrolized Whey

Soroka University Medical Center

Status: Withdrawn

Conditions: Growth Failure

Treatments: Dietary Supplement: Nan HA; Dietary Supplement: partially hydrolyzed whey

Study type: Interventional

Funder types: Other

Identifiers

NCT00548106

Sor461707ctil

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 1 to 30 days old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Infants will be fed the new hydrolyzate formula.

Treatment:

Dietary Supplement: partially hydrolyzed whey

2

Placebo Comparator group

Description:

Nan HA infant formula

Treatment:

Dietary Supplement: partially hydrolyzed whey

Dietary Supplement: Nan HA