None listed
Conditions
Brief summary
The primary objective of The Infant Feeding Study is to determine if cognitive development, as measured with the Bayley Scales of Infant Development, at 365 days (12 months) of age in term-born children is significantly improved in children fed infant formula supplemented with MFGM-rich ingredient, compared to those children fed a standard infant formula.
Interventions
This study will involve a sample of formula-fed infants that will be randomised to receive an intervention or a control formula, as well as a breast-fed sample (that will not be randomised and will not receive any study product). Infants who have identified as exclusively formula-fed will be randomised to either the; - control formula group: a cow's milk based infant formula, powdered form, or the - intervention formula group: a cow's milk based infant formula, powdered form, with additional milk fat globule membrane The Intervention Formula contains the addition of the MFGM-rich ingredient and is matched to the standard control infant formula for energy, fat, protein, carbohydrates, and key nutrients. The Intervention Formula contains ~0.53g/100g of MFGM component phospholipid. Duration of usage is from enrolment (prior to/as the infant reaches 8 weeks/60 days of age) and will continue until the infant reaches 12 months of age. Frequency and amount of consumption of the formula will be at the discretion of the parent/caregiver or healthcare professional/Investigator. Compliance will be monitored through routine feeding recall surveys. Breast-fed Reference Group - infants receiving mother's-own breast milk Families will be offered to be enrolled in the reference group if they have already self-identified that the infant is exclusively breastfed (and will not be randomised, or offered to be enrolled in either formula group). Frequency of mother's-own breast milk will be at the discretion of the parent/caregiver. Duration of mother's-own breast milk feedings is encouraged and supported from enrollment through 182 days of age. Compliance will be monitored through routine feeding recall surveys.
Sponsors
Study design
Eligibility
Inclusion criteria
•Singleton term birth (gestational age 37+0-41+6 weeks) • Appropriate birth weight for gestational age (weight >5th and <95th percentile: boys=2,604> to <4,215grams, girls=2,532> to <4,041 grams) •Caregiver or legally authorised representative is over the age of 16 and able to provide written informed consent •English is the primary language spoken at home •Caregiver or legally authorised representative agrees not to enrol the infant in another interventional clinical study that is likely to affect growth or development whilst participating in this study •Geographically located within the Adelaide Metropolitan Region, or willing to travel to a study centre for study appointments •Formula-fed groups: Exclusively formula-fed at time of enrolment (for at least 24 hours) and by 56+4 days (8 weeks) of age, and is not planning to retry breastfeeding, no medically diagnosed allergy or intolerance to lactose, soy, fish or cow’s milk protein •Breastfed group: Exclusively breastfed at 56+4 days (8 weeks) of age and planning to continue breastfeeding up to 365 days (12 months) of age
Exclusion criteria
•History of severe congenital or metabolic disease; severe congenital malformation; major birth defect or any other condition which, in the opinion of the Investigator, is likely to interfere with: o the ability of the infant to ingest food o the normal growth and development of the infant o the evaluation of the infant •Infant has/had hypoxic ischemic encephalopathy •Infant was born from mother who is diabetic (pre-existing Type 1) •Known substance or alcohol abuse during pregnancy •Infant is immunocompromised (according to a doctor’s diagnosis of immunodeficiency such as combined immunodeficiency’s, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe congenital neutropenia and secondary immunodeficiencies linked to HIV infection, Down syndrome or others) •Infant is already in a nutritional intervention study that may influence growth or development