ANZCTR - Registration

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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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Late pre-term infant

Growth rate

Condition category

Condition code

Diet and Nutrition

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]

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]

Body weight gain of late preterm infants - electronic scale

Timepoint [1]

From enrollment to 120 days (corrected age)

Secondary outcome [1]

Formula intake assessed by monthly participant diaries

Timepoint [1]

40 weeks post menstrual age, 30, 60, 90, and 120 days (late-preterm groups only)

Secondary outcome [2]

Body composition assessed by PeaPod (Infant Body Composition System)

Timepoint [2]

Enrollment and 120 days of age (corrected age for late-preterm group)

Secondary outcome [3]

Scoring Atopic Dermatitis (SCORAD) assessment

Timepoint [3]

30, 60, 90, 120, 180, and 365 days of age (corrected age for late-preterm group)

Secondary outcome [4]

Nutritional status via blood test

Timepoint [4]

120 days of age (corrected age for late-preterm group)

Secondary outcome [5]

Fecal microbiota assessment via 16S rRNA sequence profiling

Timepoint [5]

Enrollment, 60, and 120 days of age (corrected age for late-preterm group)

Secondary outcome [6]

Medically-confirmed adverse events confirmed by health care provider assessment
- Rare occurrences of formula intolerance may be possible

Timepoint [6]

Until infants reach 365 days of corrected age

Secondary outcome [7]

Body weight

Timepoint [7]

Enrollment, 40 weeks PMA (late-preterm group only), 30, 60, 90, 120, 180, and 365 days of age

Secondary outcome [8]

Recall of fecal characteristics assessed by questionnaire (questionnaire designed specifically for this study)

Timepoint [8]

30, 60, 90, and 120 days of age (corrected age for late-preterm group)

Secondary outcome [9]

Body length

Timepoint [9]

Enrollment, 40 weeks PMA (late-preterm group only), 30, 60, 90, 120, 180, and 365 days of age

Secondary outcome [10]

Head circumference

Timepoint [10]

Enrollment, 40 weeks PMA (late-preterm group only), 30, 60, 90, 120, 180, and 365 days of age

Secondary outcome [11]

Recall of dietary tolerence assessed by questionnaire (questionnaire designed specifically for this study)

Timepoint [11]

30, 60, 90, and 120 days of age (corrected age for late-preterm group)

Secondary outcome [12]

Fatty acid profile assessment via blood test

Timepoint [12]

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

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Womens and Childrens Hospital - North Adelaide

Recruitment postcode(s) [1]

5006 - North Adelaide

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Mead Johnson & Company, LLC

Address [1]

2400 West Lloyd Expressway
Evansville, IN 47721

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's & Children's Health Network Human Research Ethics Committee

Ethics committee address [1]

Level 2, Samuel Way Building
72 King William Road
North Adelaide, SA 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/05/2017

Approval date [1]

28/06/2017

Ethics approval number [1]

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

Prof Maria Makrides

Address

South Australian Health and
Medical Research Institute (SAHMRI)
72 King William Road,
North Adelaide SA. 5006

Country

Australia

Phone

+61 8 8128 4416

Fax

[email protected]

Contact person for public queries

Name

Karen Best

Address

South Australian Health and
Medical Research Institute (SAHMRI)
72 King William Road,
North Adelaide SA. 5006

Country

Australia

Phone

+61 8 8128 4404

Fax

[email protected]

Contact person for scientific queries

Name

Karen Best

Address

South Australian Health and
Medical Research Institute (SAHMRI)
72 King William Road,
North Adelaide SA. 5006

Country

Australia

Phone

+61 8 8128 4404

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Growth of late preterm infants fed nutrient-enriched formula to 120 days corrected age-A randomized controlled trial.	2023	https://dx.doi.org/10.3389/fped.2023.1146089

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically