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Trial registered on ANZCTR


Registration number
ACTRN12620000552987
Ethics application status
Approved
Date submitted
7/04/2020
Date registered
11/05/2020
Date last updated
27/10/2021
Date data sharing statement initially provided
11/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Infant Feeding Study
Scientific title
Infant nutrition with milk fat globule membrane for infant cognition in early life
Secondary ID [1] 300804 0
Nil
Universal Trial Number (UTN)
U1111-1250-1917
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infant Nutrition 316678 0
Infant Cognition 316679 0
Condition category
Condition code
Diet and Nutrition 314922 314922 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 315357 315357 0 0
Breast feeding
Reproductive Health and Childbirth 315358 315358 0 0
Childbirth and postnatal care
Neurological 315359 315359 0 0
Studies of the normal brain and nervous system
Mental Health 315360 315360 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317126 0
Treatment: Other
Comparator / control treatment
Comparator/Control treatment:
Infants in the formula-fed groups will be randomised to receive either the;
- control formula: a cow's milk based infant formula, powdered form, or the
- intervention formula: a cow's milk based infant formula, powdered form, with additional milk fat globule membrane

The Control Formula contains ~0.29g/100g of MFGM component phospholipid (as is typical of all infant formula).
Duration of usage is from enrollment (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.
Control group
Active

Outcomes
Primary outcome [1] 323235 0
Cognitive development at 365 days of age in full term children as assessed with the Bayley-IV Cognitive Scale Score
Timepoint [1] 323235 0
365 days of age
Secondary outcome [1] 381244 0
Cognitive development (Bayley-IV)
Timepoint [1] 381244 0
730 days (24 months) of age
Secondary outcome [2] 381245 0
Language development (Bayley-IV)
Timepoint [2] 381245 0
365 days (12 months) and 730 days (24 months) of age
Secondary outcome [3] 381250 0
Motor development (Bayley-IV)
Timepoint [3] 381250 0
365 days (12 months) and 730 days (24 months) of age
Secondary outcome [4] 381251 0
Parent-reported infant adaptive behaviour development (Bayley-IV)
Timepoint [4] 381251 0
365 days (12 months) and 730 days (24 months) of age
Secondary outcome [5] 381253 0
Early development of attention using an observational experimental measure of visual attention involving tracking eye movements during exposure to visual stimuli. This measure has been previously developed and used in ongoing (currently un-published) studies of nutrition and child development. This measure has not undergone validation.
Timepoint [5] 381253 0
120 days (4 months) and 273 days (9 months) of age
Secondary outcome [6] 381255 0
Parent-reported general development (Ages and Stages Questionnaire)
Timepoint [6] 381255 0
182 days (6 months) and 547 days (18 months) of age
Secondary outcome [7] 381256 0
Parent-reported language (MacArthur-Bates Communicative Development Inventory) development
Timepoint [7] 381256 0
365 days (12 months) and 730 days (24 months) of age
Secondary outcome [8] 381257 0
Infant growth (height, weight, head circumference and BMI)
Timepoint [8] 381257 0
between enrolment and 120 days (4 months), 273 days (9 months), 365 days (12 months) and 730 days (24 months) of age
Secondary outcome [9] 381258 0
Indicators of dietary tolerance based on parent-reported infant wind, fussiness, crying, vomiting, stool consistency and sleeping via a specifically developed questionnaire.
Timepoint [9] 381258 0
between enrolment and 365 days (12 months) of age
Secondary outcome [10] 381259 0
Parent-reported illness (such as fever and infections) via questionnaire that has been specifically designed and developed for the present study. This questionnaire has not undergone validation.
Timepoint [10] 381259 0
between birth and 365 days (12 months) of age
Secondary outcome [11] 381260 0
Serious adverse events, defined as
-a hospital admission >6 hours, or prolongation of existing hospitalisation
- death
- life-threatening condition
-event leading to a persistent or significant disability/incapacity

Serious adverse events will be initially self-reported by parents, and specific details will be subsequently extracted from infant medical records.
Timepoint [11] 381260 0
between enrolment and 730 days (24 months) of age
Secondary outcome [12] 382373 0
Parent-reported infant social-emotional development (Bayley-IV)
Timepoint [12] 382373 0
365 days (12 months) and 730 days (24 months) of age

Eligibility
Key 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
Minimum age
No limit
Maximum age
8 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After enrolment and consent, an Electronic Data Capture (EDC) platform will randomize participants to receive one of two study formulas. A unique participant code (Study ID) along with product code will be assigned. The product assignment number and Study ID (i.e., random number) will be recorded in the EDC
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomization schedule using balanced variable block design will be generated by an independent statistician who is not involved with study participants or data analysis.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/05/2020
Actual
11/05/2020
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
28/03/2024
Actual
Sample size
Target
600
Accrual to date
272
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 305260 0
Commercial sector/Industry
Name [1] 305260 0
Fonterra Co-Operative Group Limited
Country [1] 305260 0
Australia
Primary sponsor type
Other
Name
South Australian Health and Medical Research Institute (SAHMRI)
Address
72 King William Road, North Adelaide, South Australia, Australia, 5006.
Country
Australia
Secondary sponsor category [1] 305625 0
None
Name [1] 305625 0
Address [1] 305625 0
Country [1] 305625 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305602 0
Women's & Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 305602 0
Ethics committee country [1] 305602 0
Australia
Date submitted for ethics approval [1] 305602 0
28/08/2019
Approval date [1] 305602 0
22/11/2019
Ethics approval number [1] 305602 0
HREC/19/WCHN/140

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100930 0
Prof Maria Makrides
Address 100930 0
South Australian Health and
Medical Research Institute (SAHMRI)
72 King William Road,
North Adelaide SA. 5006
Country 100930 0
Australia
Phone 100930 0
+61 8 8128 4416
Fax 100930 0
Email 100930 0
maria.makrides@sahmri.com
Contact person for public queries
Name 100931 0
Jacqueline Gould
Address 100931 0
South Australian Health and
Medical Research Institute (SAHMRI)
72 King William Road,
North Adelaide SA. 5006
Country 100931 0
Australia
Phone 100931 0
+61 8 1828 4423
Fax 100931 0
Email 100931 0
jacqueline.gould@sahmri.com
Contact person for scientific queries
Name 100932 0
Jacqueline Gould
Address 100932 0
South Australian Health and
Medical Research Institute (SAHMRI)
72 King William Road,
North Adelaide SA. 5006
Country 100932 0
Australia
Phone 100932 0
+61 8 1828 4423
Fax 100932 0
Email 100932 0
jacqueline.gould@sahmri.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only de-identified data may be shared, with the written approval of the study Steering Committee, the WCHN HREC and the Funder.
Data will not be made publicly available in a data repository.
When will data be available (start and end dates)?
Requests for data sharing may be made after 2025, with no applicable end date.
Available to whom?
Data may be shared with researchers, government or health professionals who provide a methodologically sound proposal that is approved by the study Steering Committee, the WCHN HREC and the Funder.
Available for what types of analyses?
Analyses to achieve the aims of the proposal that is approved by the study Steering Committee, the WCHN HREC and the Funder.
How or where can data be obtained?
Others may apply for access to specific de-identified data in relation to a specific research question. Applications must be approved by the study Steering Committee, the WCHN HREC and the Funder. Applications to share data can be emailed to the chief investigator, once data collection and analyses have been complete, via. Dr Jacqueline Gould through email: jacqueline.gould@sahmri.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMilk fat globule membrane supplementation in children: Systematic review with meta-analysis.2021https://dx.doi.org/10.3390/nu13030714
N.B. These documents automatically identified may not have been verified by the study sponsor.