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Trial registered on ANZCTR


Registration number
ACTRN12621000512820
Ethics application status
Approved
Date submitted
31/03/2021
Date registered
3/05/2021
Date last updated
17/03/2024
Date data sharing statement initially provided
3/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of domperidone on breast milk supply following preterm birth- the SUMMIT follow-up study
Scientific title
SUpporting Mothers Milk Intervention Trial comparing different doses of domperidone for treating lactation insufficiency in mothers of preterm infants: A Follow-Up study (Post-SUMMIT)
Secondary ID [1] 303149 0
None
Universal Trial Number (UTN)
U1111-1263-7679
Trial acronym
Post-SUMMIT
Linked study record
This record is a follow-up study of ACTRN12621000508875

Health condition
Health condition(s) or problem(s) studied:
Lactation insufficiency 320262 0
Preterm birth 321755 0
Condition category
Condition code
Reproductive Health and Childbirth 318193 318193 0 0
Breast feeding
Reproductive Health and Childbirth 319495 319495 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a follow-up of the SUpporting Mothers Milk Intervention Trial (SUMMIT) - A randomized controlled trial comparing different doses of domperidone for treating lactation insufficiency in mothers of preterm infants. In the original study women were allocated to either receive domperidone 30 mg/day or 60 mg/day for 21 days.

Follow-up of SUMMIT study participants (mothers and their infants) will occur until the infant reaches 24-36 months corrected age. Study visits will be undertaken at one-month, three-months and six-months infant corrected age. A medical record audit will be conducted between 24-36 months corrected age. Study assessments at one-month, three-months and six-months infant corrected age will be conducted by telephone.

At each study visit women will complete questionnaires evaluating breastfeeding, breast health, maternal health, maternal mental health and wellbeing, as well as infant feeding practices and infant health, anticipated to take 30-60 minutes at each session.
Intervention code [1] 319456 0
Not applicable
Comparator / control treatment
SUMMIT study participants (mothers and infants) assigned to the comparator treatment will also be followed-up until the infant reaches 24-36 months corrected age using the same procedures as outlined above.
Control group
Active

Outcomes
Primary outcome [1] 326176 0
Proportion breastfeeding or breast milk feeding (defined as the process of feeding a mother's breast milk to her infant, either directly from the breast or by expressing the milk from the breast and bottle-feeding it to the infant) - assessed by maternal self-report using a study-specific questionnaire
Timepoint [1] 326176 0
Six months infant corrected age
Secondary outcome [1] 390388 0
Use and volume of supplementation to mother's own breast milk, such as formula or donor breast milk - assessed by maternal self-report using a study-specific questionnaire
Timepoint [1] 390388 0
One, three and six months infant corrected age
Secondary outcome [2] 390389 0
Proportion of women exclusively breastfeeding or breast milk feeding (defined as the process of feeding a mother's breast milk to her infant, either directly from the breast or by expressing the milk from the breast and bottle-feeding it to the infant) - assessed by maternal self-report using a study-specific questionnaire
Timepoint [2] 390389 0
One, three and six months infant corrected age
Secondary outcome [3] 393531 0
Total duration of any breastfeeding or breast milk feeding (defined as the process of feeding a mother's breast milk to her infant, either directly from the breast or by expressing the milk from the breast and bottle-feeding it to the infant) - assessed by maternal self-report using a study-specific questionnaire
Timepoint [3] 393531 0
Six months infant corrected age
Secondary outcome [4] 393573 0
Maternal depression assessed using the Edinburgh Postnatal Depression Scale (EPDS)
Timepoint [4] 393573 0
Three and six months infant corrected age
Secondary outcome [5] 393574 0
Maternal anxiety assessed using the State Trait Anxiety Inventory (STAI-6)
Timepoint [5] 393574 0
Three and six months infant corrected age
Secondary outcome [6] 393575 0
Maternal postnatal attachment assessed using the Maternal Postnatal Attachment Scale (MPAS)
Timepoint [6] 393575 0
Three months infant corrected age
Secondary outcome [7] 393576 0
Maternal quality of life assessed using SF-36
Timepoint [7] 393576 0
Three months infant corrected age
Secondary outcome [8] 393577 0
Infant neurodevelopment as assessed by the Bayley Scales of Infant and Toddler Development
Timepoint [8] 393577 0
At a single timepoint between 2 to 3 years infant corrected age

Eligibility
Key inclusion criteria
-All women who participated in the SUMMIT trial will be invited to participate. Selection criteria for SUMMIT include:
-Mothers of preterm infants born <34 weeks' gestation (up to 33+6)
-Lactation insufficiency defined as breast milk volume less than 300 mL/day in previous 24 hours if between 7 and 13 days postpartum, or breast milk volume less than 500 mL/day in previous 24 hours if between 14 and 28 days postpartum
-Between 7 and 28 days postpartum
-Expressing with an electric pump an average of 6 times a day or more in previous 24-48 hours
-Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessment and follow-up of mother and baby until infant discharge.
-Signed and written consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Did not participate in SUMMIT RCT

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size of 110 women (55 per arm) yields >80% power to demonstrate an absolute 25% increase (from 25% to 50%) in the proportion of women still providing any breast milk to their infant at 6 months infant corrected age, allowing for 10% loss to follow-up. This represents 65% of the original 170 women participating in the SUMMIT study.

The primary analysis will be performed according to the treatment group to which participants were randomised (intention-to-treat principle). A secondary per-protocol analysis will also be performed for each of the primary and secondary outcomes.

The primary outcome of any breastfeeding at 6 months infant corrected age will be compared between treatment groups using log-binomial regression. The results will be expressed as a difference in means with a 95% confidence interval and two-sided p-value. Adjustment will be made for baseline breast milk volume and the randomization strata (study centre, plurality [singleton birth or twin birth], and parity [1 or greater than or equal to 2]). A p-value of less than 0.05 will be considered to indicate statistical significance. Analysis of secondary outcomes will use log-binomial regression models for binary outcomes and linear regression models for continuous outcomes with adjustment for stratification variables and other pre-specified prognostic baseline variables. Results will be presented as relative risks and differences in means respectively, along with 95% confidence intervals. Missing data will be addressed using multiple imputation. Sensitivity analyses will also be performed using the original unimputed data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
4/11/2022
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
110
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 18395 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 18396 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 23551 0
The Royal Women's Hospital - Parkville
Recruitment hospital [4] 23552 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [5] 23553 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 32488 0
5006 - North Adelaide
Recruitment postcode(s) [2] 32489 0
5042 - Bedford Park
Recruitment postcode(s) [3] 38973 0
3052 - Parkville
Recruitment postcode(s) [4] 38974 0
3084 - Heidelberg
Recruitment postcode(s) [5] 38975 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 307553 0
Government body
Name [1] 307553 0
National Health and Medical Research Council
Country [1] 307553 0
Australia
Funding source category [2] 307620 0
Charities/Societies/Foundations
Name [2] 307620 0
The Hospital Research Foundation
Country [2] 307620 0
Australia
Primary sponsor type
Other Collaborative groups
Name
South Australian Health and Medical Research Institute (SAHMRI)
Address
North Terrace
Adelaide 5000
South Australia
Country
Australia
Secondary sponsor category [1] 308242 0
None
Name [1] 308242 0
Address [1] 308242 0
Country [1] 308242 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307617 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 307617 0
Women's and Children's Hospital
72 King William Road
North AdelaideSA 5006
Ethics committee country [1] 307617 0
Australia
Date submitted for ethics approval [1] 307617 0
25/09/2019
Approval date [1] 307617 0
09/09/2020
Ethics approval number [1] 307617 0
HREC/19/WCHN/149
Ethics committee name [2] 311955 0
Mercy Health Human Research Ethics Committee
Ethics committee address [2] 311955 0
Mercy Hospitals Victoria Ltd Level 2, 12 Shelley Street Richmond Vic 3121
Ethics committee country [2] 311955 0
Australia
Date submitted for ethics approval [2] 311955 0
16/11/2021
Approval date [2] 311955 0
10/02/2022
Ethics approval number [2] 311955 0
2021-065

Summary
Brief summary
Mothers of preterm infants often struggle to produce enough breast milk to meet the daily feed requirements of their infants, especially in the longer-term. This study follows the mothers and infants that have participated in the SUMMIT randomized controlled trial, and aims to compare the impact of two doses of domperidone on long-term breastfeeding, child growth and neurodevelopment up to 24-36 months infant corrected age.

Eligibility participants will be mothers of preterm infants (< 34 weeks' gestation at birth), with insufficient breast milk (<300 mL/day or < 500 mL/day depending on postnatal age), who are expressing an average of six times a day or more, between 7 to 28 days postpartum, and who participated in the SUMMIT trial. Eligible women were randomised to receive high dose (60 mg/day) or low dose (30 mg/day) domperidone for 21 days.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107878 0
A/Prof Luke Grzeskowiak
Address 107878 0
College of Medicine and Public Health
Flinders University
GPO Box 2100, Adelaide 5001, South Australia
Country 107878 0
Australia
Phone 107878 0
+61 423 554 614
Fax 107878 0
Email 107878 0
[email protected]
Contact person for public queries
Name 107879 0
A/Prof Luke Grzeskowiak
Address 107879 0
College of Medicine and Public Health
Flinders University
GPO Box 2100, Adelaide 5001, South Australia
Country 107879 0
Australia
Phone 107879 0
+61 423 554 614
Fax 107879 0
Email 107879 0
[email protected]
Contact person for scientific queries
Name 107880 0
A/Prof Luke Grzeskowiak
Address 107880 0
College of Medicine and Public Health
Flinders University
GPO Box 2100, Adelaide 5001, South Australia
Country 107880 0
Australia
Phone 107880 0
+61 423 554 614
Fax 107880 0
Email 107880 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Baseline Characteristics: including demographics, including age and study-specific measures for all participants, after de-identification.
Outcome data: all of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Beginning 3 months following main results publication with no end date
Available to whom?
To researchers who provide a methodologically sound proposal, and on a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10229Study protocol  [email protected]
10230Informed consent form  [email protected]
10291Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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