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MOM NOSE Best: Mothers Own Milk Intranasally or Standard Care in Preterm Babies with Intraventricular Haemorrhage

Mothers Own Milk Intranasally or Standard Care in Preterm Babies with Intraventricular Haemorrhage

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000542392
Enrollment
122
Registered
2026-04-30
Start date
2026-05-25
Completion date
2030-05-01
Last updated
2026-05-04

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

Conditions

None listed

Brief summary

Despite improvements in neonatal intensive care for preterm infants, the burden of brain bleeds, termed Germinal Matrix-Intraventricular Haemorrhage, remains unchanged. Complications of GMH-IVH, including post-haemorrhagic ventricular dilatation (PHVD), are associated with significant long-term morbidity, including cerebral palsy and cognitive impairment. There are currently no readily available treatment options to treat GMH-IVH, prevent progression to PHVD and lessen neurodisability. Fresh maternal breastmilk, a rich source of reparative proteins, immune cells and stem cells, represents a promising treatment pathway. We propose that treating babies with GMH-IVH with a few intranasal drops of fresh mothers' own milk twice a day for 28 days will reduce PHVD. In this study babies will be randomly allocated to receive intranasal mothers' own milk or to standard care. All other aspects of the baby's care, including head ultrasounds and longer term developmental follow up, will be in accordance with routine care.

Interventions

Intranasal fresh mothers own milk (target 1.6ml/day in divided doses) for 28 days commenced as soon as possible after Germinal Matrix Haemorrhage-Intraventricular Haemorrhage (GMH-IVH) detection, in addition to standard care. 0.8ml of fresh mothers own milk will be administered twice per day clustered around routine infant nursing cares and timed with availability of fresh mothers own milk. During a care cluster 0.4ml fresh mothers own milk (0.2ml per nostril, delivered via droplets from a syrin

Intranasal fresh mothers own milk (target 1.6ml/day in divided doses) for 28 days commenced as soon as possible after Germinal Matrix Haemorrhage-Intraventricular Haemorrhage (GMH-IVH) detection, in addition to standard care. 0.8ml of fresh mothers own milk will be administered twice per day clustered around routine infant nursing cares and timed with availability of fresh mothers own milk. During a care cluster 0.4ml fresh mothers own milk (0.2ml per nostril, delivered via droplets from a syringe) will be instilled immediately prior to and repeated immediately after a set of nursing cares . To ensure intranasal administration is tolerated, dosage will begin at 0.2mL (0.1mL per nostril) and increased over 24h. Nasal suction is to be avoided for an hour following mothers own milk intranasal administration. In case of nasal endotracheal tube placement, the full dose of mothers own milk will be administered into the contralateral nostril. All administration will occur within the neonatal unit by nursery staff. Doses will be prescribed and monitored using hospital electronic medical records. Breast milk collection: Lactation and expressing support and equipment will be offered to mothers as is standard care in the nurseries. Intranasal mothers own milk administration will need to occur within 3 hours of expression without prior refrigeration. To reduce the burden of this on families, fresh mothers own milk administration will be clustered so that only two fresh samples are needed per day (reduced to one cluster if necessary).

Sponsors

Southern Adelaide Local Health Network
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
No minimum to 37 Weeks
Healthy volunteers
No

Inclusion criteria

Preterm infants (<37 weeks gestation at birth) with any grade Germinal-Matrix-Intraventricular Haemorrhage on cranial ultrasound in the first 10 days of life

Exclusion criteria

Postnatal age greater than 10 days at time of enrolment, Congenital diagnosis associated with neurodevelopmental delay or impairment, Neonate with no reasonable likelihood of survival, Choanal atresia or anomalies that would not allow intranasal treatment, Parent with lactation contraindication(s) or parent who declines lactation initiation, Lactating parent unable to provide fresh breast milk: unable/unwilling to pump at study site or unable to have fresh mothers own milk delivered by designee at least once/day within 3 hours of pumping for 28 days

Outcome results

None listed

Source: ANZCTR · Data processed: May 7, 2026