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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000222448
Enrollment
60
Registered
2025-03-27
Start date
2025-08-04
Completion date
2025-12-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 fee

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

Sponsors

Massey University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
28 Weeks to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026