Infant nutrition with milk fat globule membrane for infant cognition in early life

South Australian Health and Medical Research Institute (SAHMRI)0 个研究点目标入组 600 人开始时间: 2020年5月11日最近更新: 2021年11月1日

试验速览

暂无简介。

•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

•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:
•othe ability of the infant to ingest food
•othe 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

发起方

South Australian Health and Medical Research Institute (SAHMRI)