The Infant Feeding Study

Not Applicable

Recruiting

• Conditions: Infant Nutrition; Infant Cognition; Diet and Nutrition - Other diet and nutrition disorders; Reproductive Health and Childbirth - Breast feeding; Reproductive Health and Childbirth - Childbirth and postnatal care; Neurological - Studies of the normal brain and nervous system; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12620000552987
• Lead Sponsor: South Australian Health and Medical Research Institute (SAHMRI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-11
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 600

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:
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified