Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000092291
Ethics application status
Approved
Date submitted
11/01/2018
Date registered
22/01/2018
Date last updated
14/12/2021
Date data sharing statement initially provided
13/02/2019
Date results information initially provided
15/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can we improve the growth of formula fed, late-preterm infants - The Gains Trial
Scientific title
A Double-blind, Controlled, Parallel-designed Trial to Investigate Nutritive Effects of a Cow's Milk-Based Infant Formula on Growth Rates of Late Preterm Infants - The Gains Trial
Secondary ID [1] 292170 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Late pre-term infant 303617 0
Growth rate 303618 0
Condition category
Condition code
Diet and Nutrition 303026 303026 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 298324 0
Treatment: Other
Comparator / control treatment
Breast-fed Reference - Term infants receiving mother's-own breast milk
a) Frequency of mother's-own breast milk will be at the discretion of the parent/caregiver and Investigator. Duration of mother's-own breast milk feedings is from enrollment through 120 days of age
b) Compliance will be monitored via recall questionnaire
Control group
Active

Outcomes
Primary outcome [1] 302395 0
Body weight gain of late preterm infants - electronic scale
Timepoint [1] 302395 0
From enrollment to 120 days (corrected age)
Secondary outcome [1] 335840 0
Formula intake assessed by monthly participant diaries
Timepoint [1] 335840 0
40 weeks post menstrual age, 30, 60, 90, and 120 days (late-preterm groups only)
Secondary outcome [2] 335841 0
Body composition assessed by PeaPod (Infant Body Composition System)
Timepoint [2] 335841 0
Enrollment and 120 days of age (corrected age for late-preterm group)
Secondary outcome [3] 335842 0
Scoring Atopic Dermatitis (SCORAD) assessment
Timepoint [3] 335842 0
30, 60, 90, 120, 180, and 365 days of age (corrected age for late-preterm group)
Secondary outcome [4] 335843 0
Nutritional status via blood test
Timepoint [4] 335843 0
120 days of age (corrected age for late-preterm group)
Secondary outcome [5] 335844 0
Fecal microbiota assessment via 16S rRNA sequence profiling
Timepoint [5] 335844 0
Enrollment, 60, and 120 days of age (corrected age for late-preterm group)
Secondary outcome [6] 335845 0
Medically-confirmed adverse events confirmed by health care provider assessment
- Rare occurrences of formula intolerance may be possible
Timepoint [6] 335845 0
Until infants reach 365 days of corrected age
Secondary outcome [7] 340708 0
Body weight
Timepoint [7] 340708 0
Enrollment, 40 weeks PMA (late-preterm group only), 30, 60, 90, 120, 180, and 365 days of age
Secondary outcome [8] 340709 0
Recall of fecal characteristics assessed by questionnaire (questionnaire designed specifically for this study)
Timepoint [8] 340709 0
30, 60, 90, and 120 days of age (corrected age for late-preterm group)
Secondary outcome [9] 342127 0
Body length
Timepoint [9] 342127 0
Enrollment, 40 weeks PMA (late-preterm group only), 30, 60, 90, 120, 180, and 365 days of age
Secondary outcome [10] 342128 0
Head circumference
Timepoint [10] 342128 0
Enrollment, 40 weeks PMA (late-preterm group only), 30, 60, 90, 120, 180, and 365 days of age
Secondary outcome [11] 342130 0
Recall of dietary tolerence assessed by questionnaire (questionnaire designed specifically for this study)
Timepoint [11] 342130 0
30, 60, 90, and 120 days of age (corrected age for late-preterm group)
Secondary outcome [12] 342131 0
Fatty acid profile assessment via blood test
Timepoint [12] 342131 0
120 days of age (corrected age for late-preterm group)

Eligibility
Key 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
Minimum age
No limit
Maximum age
14 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

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 uniquire 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
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
29/01/2018
Actual
20/02/2018
Date of last participant enrolment
Anticipated
31/05/2020
Actual
29/08/2019
Date of last data collection
Anticipated
31/05/2021
Actual
19/08/2020
Sample size
Target
300
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9424 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 18129 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 296708 0
Commercial sector/Industry
Name [1] 296708 0
Mead Johnson & Company, LLC
Country [1] 296708 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Mead Johnson & Company, LLC
Address
2400 West Lloyd Expressway
Evansville, IN 47721
Country
United States of America
Secondary sponsor category [1] 295904 0
None
Name [1] 295904 0
Address [1] 295904 0
Country [1] 295904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297935 0
Women's & Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 297935 0
Level 2, Samuel Way Building
72 King William Road
North Adelaide, SA 5006
Ethics committee country [1] 297935 0
Australia
Date submitted for ethics approval [1] 297935 0
24/05/2017
Approval date [1] 297935 0
28/06/2017
Ethics approval number [1] 297935 0
HREC/17/WCHN/84

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75506 0
Prof Maria Makrides
Address 75506 0
South Australian Health and
Medical Research Institute (SAHMRI)
72 King William Road,
North Adelaide SA. 5006
Country 75506 0
Australia
Phone 75506 0
+61 8 8128 4416
Fax 75506 0
Email 75506 0
[email protected]
Contact person for public queries
Name 75507 0
Dr Karen Best
Address 75507 0
South Australian Health and
Medical Research Institute (SAHMRI)
72 King William Road,
North Adelaide SA. 5006
Country 75507 0
Australia
Phone 75507 0
+61 8 8128 4404
Fax 75507 0
Email 75507 0
[email protected]
Contact person for scientific queries
Name 75508 0
Dr Karen Best
Address 75508 0
South Australian Health and
Medical Research Institute (SAHMRI)
72 King William Road,
North Adelaide SA. 5006
Country 75508 0
Australia
Phone 75508 0
+61 8 8128 4404
Fax 75508 0
Email 75508 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be shared as the study protocol and statistical analysis plan will be shared at the time of manuscript submission.


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
EmbaseGrowth of late preterm infants fed nutrient-enriched formula to 120 days corrected age-A randomized controlled trial.2023https://dx.doi.org/10.3389/fped.2023.1146089
N.B. These documents automatically identified may not have been verified by the study sponsor.