Could a Mother's own milk, given as nose drops, shield premature Babies' brains?
NCT ID NCT07812922
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Extremely premature babies face a high risk of bleeding in the brain during their first week of life. Researchers at two hospitals in Winnipeg are testing whether giving a baby's own mother's fresh breast milk as nasal drops for seven days can prevent this bleeding. The study plans to enroll about 67 infants born at 29 weeks or earlier and compare their outcomes with those of similar babies cared for previously. The milk is given before and after routine care sessions, up to four times a day.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fresh breast milk from the baby's own mother, given as nasal drops
- What this could lead to
- If it works, this could offer a simple, low-cost way to protect premature babies from brain bleeding, using milk their mothers already produce.
- What could go wrong
- The study is small and does not randomly assign babies, so it may not prove cause and effect. Historical comparisons can miss differences between groups, and the treatment may not reduce bleeding.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 67 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 72 hours
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Gestational age ≤29+0 weeks based on the best obstetric estimate, with first-trimester ultrasound preferred. 2. Inborn at Women's Hospital or St. Boniface Hospital, Winnipeg, Manitoba, Canada. 3. Written informed consent obtained from a parent or legal guardian; antenatal consent may be obtained when preterm delivery is anticipated. 4. Mother/birthing parent intends and is able to provide fresh own milk for study dosing; low initial milk volume is acceptable because of the small intranasal dosing requirements. 5. Enrollment within 72 hours of life. Exclusion Criteria: 1. Major congenital brain malformation, including holoprosencephaly, lissencephaly, schizencephaly, severe primary hydrocephalus, large arachnoid cyst, or other space-occupying lesion. 2. Airway or nasal anomaly precluding intranasal administration, including choanal atresia/stenosis, severe cleft palate/lip with nasal involvement, or Pierre Robin sequence with severe obstruction. 3. Trisomy 13, Trisomy 18, or another severe chromosomal/genetic disorder. 4. Acute surgical condition requiring immediate intervention, such as esophageal atresia with tracheoesophageal fistula. 5. Life-limiting condition, including comfort-care designation, anticipated survival \<72 hours, known lethal diagnosis such as bilateral renal agenesis or anencephaly, or severe birth asphyxia with anticipated poor neurologic outcome. 6. Maternal contraindication to lactation, including HIV, or inability/unwillingness to provide fresh mother's own milk. 7. Evidence of Grade III-IV intraventricular hemorrhage on cranial ultrasound before enrollment. 8. Absence of fresh own-mother/birthing-parent milk for study dosing, including circumstances in which only donor or surrogate-provided milk is available.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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