None listed
Conditions
Brief summary
The purpose of this study is to compare two types of infant formula fed to late-preterm babies; ‘routine formula’ and ‘nutrient enriched formula’. The outcomes of the formula fed late-preterm infants will also be compared to a group of term breastfed infants.
Interventions
1. Routine infant formula - A cow's milk-based formula, previously marketed in the United States
a) Frequency and amount of study formula feeding will be at the discretion of the parent/caregiver and Investigator
b) Duration of usage is from enrollment through 120 days of age
c) Compliance will be monitored via recall questionnaire
2. Nutrient enriched post-discharge infant formula - A cow's milk-based post-discharge formula (enriched with whey protein-lipid concentrate)
a)
1. Routine infant formula - A cow's milk-based formula, previously marketed in the United States a) Frequency and amount of study formula feeding will be at the discretion of the parent/caregiver and Investigator b) Duration of usage is from enrollment through 120 days of age c) Compliance will be monitored via recall questionnaire 2. Nutrient enriched post-discharge infant formula - A cow's milk-based post-discharge formula (enriched with whey protein-lipid concentrate) a) Frequency and amount of study formula feeding will be at the discretion of the parent/caregiver and Investigator b) Duration of usage is from enrollment through 120 days of age c) Compliance will be monitored via recall questionnaire
Sponsors
Mead Johnson & Company, LLC
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 14 Days
Healthy volunteers
Yes
Inclusion criteria
Formula-fed Participants: - Exclusively formula-fed for 24 hours prior to randomization - 34 to 36+6 weeks' gestation at birth - Singleton or twin birth - Appropriately grown for gestational age (weight greater than 10th and less than 95th percentile) - 34 to 40+0 weeks post menstrual age at time of randomization - Parents or legally authorized representative has adequate understanding of the English language - Geographic location is within the Adelaide Metropolitan Region or willing to travel to a study center for study appointments - Signed informed consent obtained for infant's participation in the study Breast-fed (Reference) participants: - 39 to 40+6 weeks' gestation at birth - 0-14 days of age at enrollment - Mother has intention to exclusively provide mother's-own breast milk for greater than or equal to 120 days of age - Singleton birth - Appropriately grown for gestational age (weight greater than 10th and less than 95th percentile) - Parents or legally authorized representative had adequate understanding of English language - Geographic location is within the Adelaide Metropolitan Region or willing to travel to a study center for study appointments - Signed informed consent obtained for infant's participation in the study
Exclusion criteria
Medically diagnosed major fetal abnormality or metabolic disease; infant born from a diabetic mother; infant is immunocompromised or has any other condition that is likely to interfere with normal growth and development of the infant of the ability of the infant to ingest food.
Outcome results
None listed