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Trial registered on ANZCTR

Registration number

ACTRN12625000222448

Ethics application status

Approved

Date submitted

15/11/2024

Date registered

27/03/2025

Date last updated

27/03/2025

Date data sharing statement initially provided

27/03/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Feasibility study of feeding time-matched donor human milk to preterm infants

Scientific title

Feasibility of feeding circadian time-matched donor human milk to preterm infants and the impact on infant sleep, growth and hospital outcomes.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

preterm birth

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Feeding time-matched pasteurised donor human milk to preterm infants. "Time-matched" refers that day-time expressed breast milk will be fed infants during day time, and visa versa.
Human Milk donors will be recruited and existing active donors will also be informed, all eligible donors (up to 1 year postpartum) will be accepted to donate their milk for this study. The onsite clinician will supervise this trial including feeding preterm infants during hospital admission. The intervention for feeding donor milk will be 7 days during hospital stay for this study. The mother-infant dyad will be followed at 40 gestational ages (corrected), 12 and 24 weeks, a Research assistant will follow up with the patient via regular contact to check out the feeding status. The method of allocation will be alternating

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group: preterm infants will be fed pasteurised donor human milk by following the current routine practice (be mistimed).
Donors be enrolled into this study prospectively, and infants will be fed for 7-day period for this study. The treatment only occur during hospital admission.
A research assistant will follow up with the patient via regular contact to check out the feeding status.

Control group

Active

Outcomes

Primary outcome [1]

Exploring the impact of feeding time-matched PDHM on infants’ length of hospital stay

Timepoint [1]

Up to the time infants are ready to be discharged from the hospital - to obtain the length of time stays.

Primary outcome [2]

Exploring the impact of feeding time-matched PDHM on infants’ growth

Timepoint [2]

Daily for 7 day trial post-enrolment period

Primary outcome [3]

Examining the impact of feeding time-matched pasturised donor human milk on infants’ sleep duration during hospital stays

Timepoint [3]

Daily for 7 days post-enrolment, then once at the 40 weeks gestation ages, 12 weeks and 24 weeks post-partum.

Secondary outcome [1]

Examining the concentrations of nutritional profiles in pasteurised donor human milk and mothers' expressed breast milk BM

Timepoint [1]

at the completion of all breast milk donations.

Secondary outcome [2]

Exploring the extended impact of using time-matched pasteurised donor human milk on sleep consolidation at 40 weeks correct gestational ages

Timepoint [2]

at 40 weeks correct gestational ages

Secondary outcome [3]

Examine the concentrations of relevant hormones in PDHM and Expressed Breast Milk (EBM) - Melatonin and Cortisol

Timepoint [3]

At the time donor milk were collected

Secondary outcome [4]

Exploring the extended impact of using time-matched pasteurised donor human milk on sleep consolidation at 12 weeks postpartum

Timepoint [4]

At 12 weeks postpartum

Secondary outcome [5]

Exploring the extended impact of using time-matched pasteurised donor human milk on sleep consolidation at 24 weeks postpartum

Timepoint [5]

At 24 weeks postpartum

Secondary outcome [6]

Evaluating the feasibility of processing time-matched PDHM from health professional perspectives

Timepoint [6]

At the end of the study period.

Secondary outcome [7]

Evaluating the feasibility of processing time-matched PDHM from donors' perspectives

Timepoint [7]

At the end of donation

Eligibility

Key inclusion criteria

Donors
• Women who have surplus mature milk
• Women who resident between Wellington and Palmerston North cities
• Women who have given birth within the last six months
• Women who satisfy the inclusion/exclusion criteria from donor screening tests
Recipients
• Hospitalised preterm infants gestational ages at birth of (28 weeks +0 days) to (31 weeks +6 days)
• Tolerant with PDHM
• At least 50% of feeding is PDHM
• Informed consent of feeding with PDHM gained from infants’ mothers
Recipients’ mothers
• Women who are willing to express milk for their infants.
Health Professionals
• Have been involved in collecting, processing, pasteurising, and feeding PDHM to study participants

Minimum age

28 Weeks

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Donors
• Women will be excluded if they are taking medication or supplements to help with sleep (such as melatonin or herbal tablets) and
• Women who have been diagnosed with a sleep disorder.

Recipients
• Neonates born before 28 weeks or after 34 weeks of gestation
• Any medical conditions prevent them from using PDHM or any significant health complications

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/05/2025

Actual

Date of last participant enrolment

Anticipated

31/12/2025

Actual

Date of last data collection

Anticipated

1/08/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

New Zealand Health Research Council

Address [1]

Country [1]

New Zealand

Primary sponsor type

University

Name

Massey University

Address

Country

New Zealand

Secondary sponsor category [1]

Hospital

Name [1]

Wellington Hospital

Address [1]

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committee

Ethics committee address [1]

https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

17/02/2025

Approval date [1]

21/03/2025

Ethics approval number [1]

Summary

Brief summary

Donor human milk (DHM) is recommended as the next best alternative if the mother’s milk is temporarily unavailable. In New Zealand, preterm infants are fed with pasteurised DHM (PDHM). It is mistimed since the current practice in human milk banks is to combine DHM for pasteurisation, regardless of the time of milk donation. This creates a mismatch between the timing of DHM expression and the time of infant feeding. Evidence has shown that feeding mistimed human milk may increase the risk of later sleep problems and the risk of being obese in later life. The proposed research will use a mixed method to explore the feasibility of using a time-matched DHM and hypothesises that providing time-matched PDHM will improve sleep patterns, reduce the length of hospital stays and support infants’ growth. If effective, this research will contribute to transforming current human milk banking practices and ultimately improve the well-being of preterm infants.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Ying Jin

Address

Riddet Road, Massey University, Palmerston North 4410

Country

New Zealand

Phone

+64 69517556

Fax

[email protected]

Contact person for public queries

Name

Ying Jin

Address

Riddet Road, Massey University, Palmerston North 4410

Country

New Zealand

Phone

+64 69517556

Fax

[email protected]

Contact person for scientific queries

Name

Ying Jin

Address

Riddet Road, Massey University, Palmerston North 4410

Country

New Zealand

Phone

+64 69517556

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically