Growth Failure
Conditions
Keywords
infant formula, milk allergy, hydrolized whey
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
Interventions
DIETARY_SUPPLEMENTpartially hydrolyzed whey
Total infant feeding by study formula.
DIETARY_SUPPLEMENTNan HA
Total infant diet by study formula.
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth parameters, colic and bowel movements parameters. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Side effects | 3 months |
Countries
Israel
Outcome results
None listed