Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001471774
Ethics application status
Approved
Date submitted
21/10/2022
Date registered
22/11/2022
Date last updated
22/11/2022
Date data sharing statement initially provided
22/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising maternal breastmilk and breastfeeding in preterm and very low birthweight infants: a retrospective review of the impact of donor milk and an expressing box
Scientific title
Optimising maternal breastmilk and breastfeeding in preterm and very low birthweight infants: a retrospective review of the impact of donor milk and an expressing box
Secondary ID [1] 308237 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prematurity 327998 0
very low birthweight 327999 0
Condition category
Condition code
Reproductive Health and Childbirth 325118 325118 0 0
Breast feeding
Reproductive Health and Childbirth 325119 325119 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
Retrospective casenote review of infants from specified groups below.

Group A: Prior to the introduction of pasteurised donor human milk (PDHM) 1/1/2018 - 30/6/2018
Group B: Introduction of PDHM and specific lactation support through the creation of a dedicated International Board-Certified role within the Neonatal Unit. The IBCLC was employed on a 0.5 part-time basis with the primary focus on infants born <32 weeks gestation or < 1500 grams at birth at Flinders Medical Centre, 1/9/2019 - 29/2/2020 and the co-ordination of PDHM use. IBCLC support as provided as needed/desired by the parents during the admission.
PDHM was available to eligible infants up until 32-34 weeks corrected gestational age (if born <32 weeks gestation) or 14 days (if born <1500 grams). It could not be utilised outside of the Flinders Medical Centre. Variations in length of use could occur with neonatal consultant discretion.
Group C: Introduction of an expressing box containing, syringes, medicine straws, expressing kit, expressing information booklet, milk storage guidelines and expressing kit cleaning guidelines, 1/9/2020 - 28/2/2021. Practical demonstrations may/may not have occurred at the time of the provision of the expressing box, as it could have been provided to the mother or father/partner initially. Demonstrations could have been provided by the IBCLC, bedside nurse or midwife caring for the mother in the birthing/postnatal areas.
The expressing information booklet was created by the IBCLC using Flinders Medical Centre guidelines, with instructions on hand expressing and Medela Symphony electric pump use (as per manufacturers recommendations). Cleaning instructions were per manufacturers recommendations. Milk storage guidelines provided as per South Australian and Flinders Medical Centre recommendations. The expressing equipment could be taken home as desired.

The duration of observation of each infant varied depending on their clinical condition and actual discharge.
Please note that I have inserted '16' as the number of weeks as I was unable to write a comment. The duration of each infant varied depending on their clinical condition and actual discharge.
Intervention code [1] 324702 0
Diagnosis / Prognosis
Comparator / control treatment
Group A (1/1/2018-30/6/2018) was the historical control group, prior to changes in clinical practice. It included premature infants born <32 weeks gestation and/or < 1500 grams at birth who were born at Flinders Medical Centre or retrieved there shortly after birth.
Control group
Historical

Outcomes
Primary outcome [1] 332886 0
Changes in types of feeding at discharge following the introduction of PDHM.
Timepoint [1] 332886 0
Time of discharge from the Neonatal Unit/Neonatal Early Discharge Program
Primary outcome [2] 332887 0
Changes in early initiation of expression through introduction of the expressing box. Data collected through infant/maternal medical records.
Timepoint [2] 332887 0
Within 6 hours of birth
Primary outcome [3] 333166 0
Time of first breastmilk expression
Timepoint [3] 333166 0
Time of first breastmilk expression as recorded in the medical records
Secondary outcome [1] 414984 0
Timing of the first exposure to maternal breastmilk (MBM) as recorded in the medical records.
Timepoint [1] 414984 0
Discharge of the infant from the NNU or from the Neonatal Early Discharge program
Secondary outcome [2] 414985 0
Timing of the first skin-to-skin cuddle with the mother as recorded in the infant medical records
Timepoint [2] 414985 0
Time of the first skin to skin cuddle
Secondary outcome [3] 414986 0
The timing (corrected gestational age) of the first breastfeed attempt as recorded in the infant medical records.
Timepoint [3] 414986 0
Time (corrected gestational age) at first breastfeed attempt
Secondary outcome [4] 414987 0
The use of PDHM as recorded in the infant medical records.
Timepoint [4] 414987 0
Discharge
Secondary outcome [5] 416012 0
Feeding type (exclusive breastfeeding, exclusive breastmilk feeding, mixed feeding, standard formula feeding or specialist formula feeding) at discharge as recorded in the infant medical records and Neo database discharge information.
Timepoint [5] 416012 0
Time of discharge

Eligibility
Key inclusion criteria
Infants born <32 weeks gestation or <1500 grams at birth, born at or retrieved shortly after birth to Flinders Medical Centre Neonatal Unit whose mothers intended to breastfeed/breastmilk feed and who remained in the Neonatal Unit until discharge home/Neonatal Early Discharge program.
Minimum age
No limit
Maximum age
35 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Born 32 weeks or greater, or 1500 grams or greater, mother did not intend to provide breastmilk or was transferred to another hospital prior to discharge home. Infants whose mothers were not present during admission or were removed from the maternal care were excluded.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/09/2020
Date of last participant enrolment
Anticipated
Actual
28/02/2021
Date of last data collection
Anticipated
Actual
30/08/2022
Sample size
Target
75
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 23428 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 38830 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 312494 0
Self funded/Unfunded
Name [1] 312494 0
Jacinta Stone
Country [1] 312494 0
Australia
Primary sponsor type
Individual
Name
Jacinta Stone
Address
C/- Flinders Medical Centre
Neonatal Unit
Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 314158 0
None
Name [1] 314158 0
None
Address [1] 314158 0
N/A
Country [1] 314158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311829 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 311829 0
Ethics committee country [1] 311829 0
Australia
Date submitted for ethics approval [1] 311829 0
Approval date [1] 311829 0
17/09/2020
Ethics approval number [1] 311829 0
195.20

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

Contacts
Principal investigator
Name 122518 0
Mrs Jacinta Stone
Address 122518 0
C/- Flinders Medical Centre
Neonatal Unit
Flinders Drive
Bedford Park SA 5042
Country 122518 0
Australia
Phone 122518 0
+61882046692
Fax 122518 0
Email 122518 0
[email protected]
Contact person for public queries
Name 122519 0
Jacinta Stone
Address 122519 0
C/- Flinders Medical Centre
Neonatal Unit
Flinders Drive
Bedford Park SA 5042
Country 122519 0
Australia
Phone 122519 0
+61882046692
Fax 122519 0
Email 122519 0
[email protected]
Contact person for scientific queries
Name 122520 0
Jacinta Stone
Address 122520 0
C/- Flinders Medical Centre
Neonatal Unit
Flinders Drive
Bedford Park SA 5042
Country 122520 0
Australia
Phone 122520 0
+61882046692
Fax 122520 0
Email 122520 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
Consent has not been obtained for this.


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
No additional documents have been identified.