Intraventricular HemorrhageiF-MOM-IVHNCT07812922
Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants
A study testing Intranasal Fresh Mother's Own Milk (iF-MOM) in people with Intraventricular Hemorrhage and Premature Birth, run by University of Manitoba.
Trial summary
Babies born very prematurely are at risk of intraventricular hemorrhage (IVH), which is bleeding in or around the fluid-filled spaces of the brain. Most IVH occurs during the first week after birth. Read more about this study
- Who is it for?
- Ages 0 to 72 hours
- Conditions the study is for
- Intraventricular Hemorrhage, Premature Birth
- What is being tested?
- Intranasal Fresh Mother's Own Milk (iF-MOM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age ≤29+0 weeks based on the best obstetric estimate, with first-trimester ultrasound preferred.
- Inborn at Women's Hospital or St. Boniface Hospital, Winnipeg, Manitoba, Canada.
- Written informed consent obtained from a parent or legal guardian; antenatal consent may be obtained when preterm delivery is anticipated.
- 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.
- Enrollment within 72 hours of life.
Who cannot join
- Major congenital brain malformation, including holoprosencephaly, lissencephaly, schizencephaly, severe primary hydrocephalus, large arachnoid cyst, or other space-occupying lesion.
- 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.
- Trisomy 13, Trisomy 18, or another severe chromosomal/genetic disorder.
- Acute surgical condition requiring immediate intervention, such as esophageal atresia with tracheoesophageal fistula.
- 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.
- Maternal contraindication to lactation, including HIV, or inability/unwillingness to provide fresh mother's own milk.
- Evidence of Grade III-IV intraventricular hemorrhage on cranial ultrasound before enrollment.
- Absence of fresh own-mother/birthing-parent milk for study dosing, including circumstances in which only donor or surrogate-provided milk is available.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intranasal Fresh Mother's Own Milk (iF-MOM) for Prevention of Intraventricular Hemorrhage in Extremely Preterm Infants ≤29 Weeks' Gestational Age: A Prospective, Nonrandomized Interventional Study With Propensity Score-Weighted Historical Controls
Babies born very prematurely are at risk of intraventricular hemorrhage (IVH), which is bleeding in or around the fluid-filled spaces of the brain. Most IVH occurs during the first week after birth. Human colostrum and early breast milk contain growth factors, neurotrophic factors, immune-modulating substances, antioxidants, and other biologically active components that may have neuroprotective effects.
This study will evaluate whether giving very small amounts of a baby's own mother's fresh breast milk as nasal drops during the first 7 days of life may help prevent IVH in infants born at 29 weeks' gestation or earlier.
Read more
Approximately 67 eligible infants will be enrolled prospectively at Women's Hospital and St. Boniface Hospital in Winnipeg, Manitoba, Canada. At each scheduled study care session, fresh mother's own milk will be administered intranasally at 0.2 mL per nostril (0.4 mL total) before routine nursing care and, if tolerated and the infant remains clinically stable, repeated after care. Thus, a completed care session provides up to 0.8 mL. Study administration will be coordinated with 2-4 routine care sessions per day for 7 consecutive days, corresponding to a planned total daily volume of 1.6-3.2 mL.
The main study outcome is whether IVH of any grade is present on the routine cranial ultrasound performed at 4 to 7 days of life. Other outcomes include severe IVH, progression of IVH, post-hemorrhagic ventricular complications, mortality before hospital discharge, and the safety and tolerability of intranasal mother's own milk.
Outcomes in the prospectively treated infants will be compared with those of eligible infants previously cared for at the same neonatal intensive care units between 2020 and 2025. Statistical methods using propensity score weighting will be used to account for measured differences between the prospectively treated infants and the historical comparison group.
Read the detailed description
Intraventricular hemorrhage (IVH) remains an important complication of extreme prematurity and occurs predominantly during the first postnatal week. The immature germinal matrix vasculature, impaired cerebral autoregulation, hemodynamic instability, inflammation, oxidative stress, and other factors contribute to vulnerability to hemorrhage in extremely preterm infants.
Fresh colostrum and early mother's own milk contain multiple biologically active constituents with potential neuroprotective effects, including growth factors, neurotrophins, anti-inflammatory and immune-modulating mediators, antioxidants, and other bioactive components. Intranasal administration is being evaluated as a non-invasive route that may permit exposure of the central nervous system to milk-derived bioactive factors through proposed olfactory, trigeminal, perineural, and perivascular pathways.
This is a prospective, nonrandomized interventional study conducted at Women's Hospital and St. Boniface Hospital in Winnipeg, Manitoba, Canada. Eligible inborn infants at 29+0 weeks' gestation or less will be prospectively enrolled within 72 hours of birth. Enrolled infants will receive intranasal fresh mother's own milk during the first 7 days of life.
Fresh milk from the infant's own mother or birthing parent will be used. Milk used for study dosing will not be refrigerated or frozen before intranasal administration and will be used within 3 hours of expression. Each study dose consists of 0.2 mL administered into each nostril, for a total of 0.4 mL per dose. Doses will be administered 2 to 4 times daily for 7 consecutive days, coordinated with routine nursing care when possible. Clinical feeding and oral immune therapy needs will take priority over study dosing.
Infants will remain on continuous cardiorespiratory monitoring and pulse oximetry. Safety assessments will be performed during dosing and for at least 60 minutes after each administration. Study dosing may be delayed, withheld, or stopped if prespecified clinical instability or safety concerns occur.
The primary outcome is the presence of any IVH, Papile Grades I-IV, on cranial ultrasound performed at 4 to 7 days of life. Secondary outcomes include severe IVH, progression of IVH on subsequent imaging, post-hemorrhagic ventricular complications requiring intervention, all-cause mortality through hospital discharge, and safety and tolerability outcomes related to intranasal administration.
The study will enroll approximately 67 prospectively treated infants. Their outcomes will be compared with those of up to 188 historical controls admitted to the same two neonatal intensive care units between January 1, 2020 and December 31, 2025. Historical controls will meet the prespecified eligibility criteria and must have a documented cranial ultrasound at 4 to 7 days of life.
Because participants are not randomized to a concurrent control group, propensity scores will be estimated using prespecified maternal and neonatal characteristics. Stabilized inverse probability of treatment weighting and weighted regression methods will be used to reduce measured baseline imbalance between the prospectively treated infants and historical controls. The primary cranial ultrasound outcome will be assessed by a reviewer blinded to intervention versus historical-control status.
An optional mechanistic sub-study will permit storage and analysis of small leftover aliquots of study milk from Day 1 and Day 7, when sufficient milk remains after clinical and study dosing requirements are met. These samples will be used for approved analyses of selected naturally occurring milk components, including growth factors and neurotrophins.
- Conditions
- Intraventricular Hemorrhage, Premature Birth
- Being tested
- Intranasal Fresh Mother's Own Milk (iF-MOM)
- Keywords
- Extremely Preterm Infant, Intraventricular Hemorrhage Prevention, Germinal Matrix Hemorrhage, Intranasal Human Milk, Mother's Own Milk, Breast Milk, Neonatal Neuroprotection, Preterm Brain Injury, Colostrum, iF-MOM
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal Fresh Mother's Own Milk (iF-MOM)Other
Fresh breast milk from the infant's own mother/birthing parent will be administered intranasally. The initial volume is 0.2 mL into each nostril (0.4 mL total per administration). If tolerated, the volume may be increased to 0.4 mL into each nostril (0.8 mL total per administration). Administration will occur 2-4 times daily for 7 consecutive days. Milk used for study dosing will be fresh from expression, maintained at room temperature, never refrigerated or frozen before administration, and used within 3 hours of expression.
| Study group | Role | What they receive |
|---|---|---|
| iF-MOM Intervention | Experimental | Eligible extremely preterm infants born at ≤29+0 weeks' gestation will receive intranasal fresh mother's own milk (iF-MOM) in addition to standard neonatal intensive care. The initial administration volume is 0.2 mL per nostril (0.4 mL total). If tolerated without a clinically significant administration-related adverse event, the volume may be increased to 0.4 mL per nostril (0.8 mL total) at the discretion of the treating/study clinical team. Intranasal administrations will occur 2-4 times daily, coordinated around routine nursing care, for 7 consecutive days. Receives: Other: Intranasal Fresh Mother's Own Milk (iF-MOM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Any-Grade Intraventricular Hemorrhage (Papile Grades I-IV)
Presence of any intraventricular hemorrhage (IVH), Papile Grades I-IV, assessed on the standardized cranial ultrasound performed at 4-7 days of life.
Measured: 4 to 7 days of life
Secondary outcomes (5)
Incidence of Severe Intraventricular Hemorrhage (Papile Grades III-IV)
Presence of severe IVH, defined as Papile Grade III or IV, on the day 4-7 cranial ultrasound or subsequent clinically indicated cranial ultrasound imaging.
Measured: From the initial cranial ultrasound performed at 4-7 days of life through hospital discharge, up to 6 months of life
Progression of Intraventricular Hemorrhage
Worsening of IVH grade on repeat cranial ultrasound compared with the initial day 4-7 cranial ultrasound.
Measured: From the initial cranial ultrasound performed at 4-7 days of life through hospital discharge, up to 6 months of life
Post-Hemorrhagic Ventricular Dilatation Requiring Intervention
Development of post-hemorrhagic ventricular dilatation requiring clinical or neurosurgical intervention, including ventriculoperitoneal shunt when applicable.
Measured: From the initial cranial ultrasound performed at 4-7 days of life through hospital discharge, up to 6 months of life
All-Cause Mortality
Death from any cause occurring before hospital discharge.
Measured: From birth until death or hospital discharge, whichever occurs first, assessed up to 6 months of life
Incidence and Severity of Adverse Events Associated With Intranasal iF-MOM Administration
Adverse events occurring during or after iF-MOM administration will be recorded and classified as mild, moderate, severe, or serious according to the prespecified study safety criteria.
Measured: During the 7-day intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intraventricular HemorrhageStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible infants are prospectively assigned to receive intranasal fresh mother's own milk during the first 7 days of life. There is no concurrently assigned control arm. Outcomes will be compared with eligible historical controls cared for at the same two neonatal intensive care units between 2020 and 2025 using propensity score weighting. The primary cranial ultrasound outcome will be interpreted by a reviewer blinded to prospective intervention versus historical-control status.
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Narvey, University of Manitoba
- Investigators
- Michael Narvey, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812922
- Sponsor's protocol ID
- iF-MOM-IVH
- Acronym
- iF-MOM-IVH
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagy Z, Obeidat M, Mate V, Nagy R, Szanto E, Veres DS, Koi T, Hegyi P, Major GS, Garami M, Gasparics A, Te Pas AB, Szabo M. Occurrence and Time of Onset of Intraventricular Hemorrhage in Preterm Neonates: A Systematic Review and Meta-Analysis of Individual Patient Data. JAMA Pediatr. 2025 Feb 1;179(2):145-154. doi: 10.1001/jamapediatrics.2024.5998.
PubMed 39786414Sonmez Demir G, Ozdemir OM, Turgut M, Pekal Y, Koyuncu E, Gungor O, Ergin H. Impact of Intranasal Administration of Fresh Breast Milk in Very Low Birth Weight Infants With Germinal Matrix-Intraventricular Hemorrhage. Cureus. 2025 Mar 11;17(3):e80416. doi: 10.7759/cureus.80416. eCollection 2025 Mar.
PubMed 40213722Gallipoli A, Unger S, El Shahed A, Fan CS, Signorile M, Wilson D, Hoban R. Outcomes after intranasal human milk therapy in preterm infants with intraventricular hemorrhage. J Perinatol. 2025 Feb;45(2):202-207. doi: 10.1038/s41372-024-02147-3. Epub 2024 Oct 9.
PubMed 39384614Hoban R, Gallipoli A, Signorile M, Mander P, Gauthier-Fisher A, Librach C, Wilson D, Unger S. Feasibility of intranasal human milk as stem cell therapy in preterm infants with intraventricular hemorrhage. J Perinatol. 2024 Nov;44(11):1652-1657. doi: 10.1038/s41372-024-01982-8. Epub 2024 Apr 30.
PubMed 38688998Keller T, Korber F, Oberthuer A, Schafmeyer L, Mehler K, Kuhr K, Kribs A. Intranasal breast milk for premature infants with severe intraventricular hemorrhage-an observation. Eur J Pediatr. 2019 Feb;178(2):199-206. doi: 10.1007/s00431-018-3279-7. Epub 2018 Nov 1.
PubMed 30386923
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Fresh Mother's Own Milk (iF-MOM) for Prevention of Intraventricular Hemorrhage in Extremely Preterm Infants ≤29 Weeks' Gestational Age: A Prospective, Nonrandomized Interventional Study With Propensity Score-Weighted Historical Controls
- ClinicalTrials.gov ID
- NCT07812922
- Acronym / sponsor ID
- iF-MOM-IVH / iF-MOM-IVH
- Conditions
- Intraventricular Hemorrhage, Premature Birth
- Keywords
- Extremely Preterm Infant, Intraventricular Hemorrhage Prevention, Germinal Matrix Hemorrhage, Intranasal Human Milk, Mother's Own Milk, Breast Milk, Neonatal Neuroprotection, Preterm Brain Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Babies born very prematurely are at risk of intraventricular hemorrhage (IVH), which is bleeding in or around the fluid-filled spaces of the brain. Most IVH occurs during the first week after birth. Human colostrum and early breast milk contain growth factors, neurotrophic factors, immune-modulating substances, antioxidants, and other biologically active components that may have neuroprotective effects.
This study will evaluate whether giving very small amounts of a baby's own mother's fresh breast milk as nasal drops during the first 7 days of life may help prevent IVH in infants born at 29 weeks' gestation or earlier.
Approximately 67 eligible infants will be enrolled prospectively at Women's Hospital and St. Boniface Hospital in Winnipeg, Manitoba, Canada. At each scheduled study care session, fresh mother's own milk will be administered intranasally at 0.2 mL per nostril (0.4 mL total) before routine nursing care and, if tolerated and the infant remains clinically stable, repeated after care. Thus, a completed care session provides up to 0.8 mL. Study administration will be coordinated with 2-4 routine care sessions per day for 7 consecutive days, corresponding to a planned total daily volume of 1.6-3.2 mL.
The main study outcome is whether IVH of any grade is present on the routine cranial ultrasound performed at 4 to 7 days of life. Other outcomes include severe IVH, progression of IVH, post-hemorrhagic ventricular complications, mortality before hospital discharge, and the safety and tolerability of intranasal mother's own milk.
Outcomes in the prospectively treated infants will be compared with those of eligible infants previously cared for at the same neonatal intensive care units between 2020 and 2025. Statistical methods using propensity score weighting will be used to account for measured differences between the prospectively treated infants and the historical comparison group.
Detailed description
Intraventricular hemorrhage (IVH) remains an important complication of extreme prematurity and occurs predominantly during the first postnatal week. The immature germinal matrix vasculature, impaired cerebral autoregulation, hemodynamic instability, inflammation, oxidative stress, and other factors contribute to vulnerability to hemorrhage in extremely preterm infants.
Fresh colostrum and early mother's own milk contain multiple biologically active constituents with potential neuroprotective effects, including growth factors, neurotrophins, anti-inflammatory and immune-modulating mediators, antioxidants, and other bioactive components. Intranasal administration is being evaluated as a non-invasive route that may permit exposure of the central nervous system to milk-derived bioactive factors through proposed olfactory, trigeminal, perineural, and perivascular pathways.
This is a prospective, nonrandomized interventional study conducted at Women's Hospital and St. Boniface Hospital in Winnipeg, Manitoba, Canada. Eligible inborn infants at 29+0 weeks' gestation or less will be prospectively enrolled within 72 hours of birth. Enrolled infants will receive intranasal fresh mother's own milk during the first 7 days of life.
Fresh milk from the infant's own mother or birthing parent will be used. Milk used for study dosing will not be refrigerated or frozen before intranasal administration and will be used within 3 hours of expression. Each study dose consists of 0.2 mL administered into each nostril, for a total of 0.4 mL per dose. Doses will be administered 2 to 4 times daily for 7 consecutive days, coordinated with routine nursing care when possible. Clinical feeding and oral immune therapy needs will take priority over study dosing.
Infants will remain on continuous cardiorespiratory monitoring and pulse oximetry. Safety assessments will be performed during dosing and for at least 60 minutes after each administration. Study dosing may be delayed, withheld, or stopped if prespecified clinical instability or safety concerns occur.
The primary outcome is the presence of any IVH, Papile Grades I-IV, on cranial ultrasound performed at 4 to 7 days of life. Secondary outcomes include severe IVH, progression of IVH on subsequent imaging, post-hemorrhagic ventricular complications requiring intervention, all-cause mortality through hospital discharge, and safety and tolerability outcomes related to intranasal administration.
The study will enroll approximately 67 prospectively treated infants. Their outcomes will be compared with those of up to 188 historical controls admitted to the same two neonatal intensive care units between January 1, 2020 and December 31, 2025. Historical controls will meet the prespecified eligibility criteria and must have a documented cranial ultrasound at 4 to 7 days of life.
Because participants are not randomized to a concurrent control group, propensity scores will be estimated using prespecified maternal and neonatal characteristics. Stabilized inverse probability of treatment weighting and weighted regression methods will be used to reduce measured baseline imbalance between the prospectively treated infants and historical controls. The primary cranial ultrasound outcome will be assessed by a reviewer blinded to intervention versus historical-control status.
An optional mechanistic sub-study will permit storage and analysis of small leftover aliquots of study milk from Day 1 and Day 7, when sufficient milk remains after clinical and study dosing requirements are met. These samples will be used for approved analyses of selected naturally occurring milk components, including growth factors and neurotrophins.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible infants are prospectively assigned to receive intranasal fresh mother's own milk during the first 7 days of life. There is no concurrently assigned control arm. Outcomes will be compared with eligible historical controls cared for at the same two neonatal intensive care units between 2020 and 2025 using propensity score weighting. The primary cranial ultrasound outcome will be interpreted by a reviewer blinded to prospective intervention versus historical-control status.
| Arm | Type | Receives |
|---|---|---|
| iF-MOM Intervention | Experimental | Other: Intranasal Fresh Mother's Own Milk (iF-MOM)Eligible extremely preterm infants born at ≤29+0 weeks' gestation will receive intranasal fresh mother's own milk (iF-MOM) in addition to standard neonatal intensive care. The initial administration volume is 0.2 mL per nostril (0.4 mL total). If tolerated without a clinically significant administration-related adverse event, the volume may be increased to 0.4 mL per nostril (0.8 mL total) at the discretion of the treating/study clinical team. Intranasal administrations will occur 2-4 times daily, coordinated around routine nursing care, for 7 consecutive days. |
Who may qualify
- Ages
- 0 to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age ≤29+0 weeks based on the best obstetric estimate, with first-trimester ultrasound preferred.
- Inborn at Women's Hospital or St. Boniface Hospital, Winnipeg, Manitoba, Canada.
- Written informed consent obtained from a parent or legal guardian; antenatal consent may be obtained when preterm delivery is anticipated.
- 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.
- Enrollment within 72 hours of life.
Key exclusion criteria (8 listed)
- Major congenital brain malformation, including holoprosencephaly, lissencephaly, schizencephaly, severe primary hydrocephalus, large arachnoid cyst, or other space-occupying lesion.
- 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.
- Trisomy 13, Trisomy 18, or another severe chromosomal/genetic disorder.
- Acute surgical condition requiring immediate intervention, such as esophageal atresia with tracheoesophageal fistula.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal Fresh Mother's Own Milk (iF-MOM)Fresh breast milk from the infant's own mother/birthing parent will be administered intranasally. The initial volume is 0.2 mL into each nostril (0.4 mL total per administration). If tolerated, the volume may be increased to 0.4 mL into each nostril (0.8 mL total per administration). Administration will occur 2-4 times daily for 7 consecutive days. Milk used for study dosing will be fresh from expression, maintained at room temperature, never refrigerated or frozen before administration, and used within 3 hours of expression. | Other | iF-MOM Intervention |
Primary outcome
Incidence of Any-Grade Intraventricular Hemorrhage (Papile Grades I-IV)
Time frame: 4 to 7 days of life
Presence of any intraventricular hemorrhage (IVH), Papile Grades I-IV, assessed on the standardized cranial ultrasound performed at 4-7 days of life.
5 secondary outcomes
Incidence of Severe Intraventricular Hemorrhage (Papile Grades III-IV)
Time frame: From the initial cranial ultrasound performed at 4-7 days of life through hospital discharge, up to 6 months of life
Progression of Intraventricular Hemorrhage
Time frame: From the initial cranial ultrasound performed at 4-7 days of life through hospital discharge, up to 6 months of life
Post-Hemorrhagic Ventricular Dilatation Requiring Intervention
Time frame: From the initial cranial ultrasound performed at 4-7 days of life through hospital discharge, up to 6 months of life
All-Cause Mortality
Time frame: From birth until death or hospital discharge, whichever occurs first, assessed up to 6 months of life
Incidence and Severity of Adverse Events Associated With Intranasal iF-MOM Administration
Time frame: During the 7-day intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 39786414Nagy Z, Obeidat M, Mate V, Nagy R, Szanto E, Veres DS, Koi T, Hegyi P, Major GS, Garami M, Gasparics A, Te Pas AB, Szabo M. Occurrence and Time of Onset of Intraventricular Hemorrhage in Preterm Neonates: A Systematic Review and Meta-Analysis of Individual Patient Data. JAMA Pediatr. 2025 Feb 1;179(2):145-154. doi: 10.1001/jamapediatrics.2024.5998.
- Background: PubMed 40213722Sonmez Demir G, Ozdemir OM, Turgut M, Pekal Y, Koyuncu E, Gungor O, Ergin H. Impact of Intranasal Administration of Fresh Breast Milk in Very Low Birth Weight Infants With Germinal Matrix-Intraventricular Hemorrhage. Cureus. 2025 Mar 11;17(3):e80416. doi: 10.7759/cureus.80416. eCollection 2025 Mar.
- Background: PubMed 39384614Gallipoli A, Unger S, El Shahed A, Fan CS, Signorile M, Wilson D, Hoban R. Outcomes after intranasal human milk therapy in preterm infants with intraventricular hemorrhage. J Perinatol. 2025 Feb;45(2):202-207. doi: 10.1038/s41372-024-02147-3. Epub 2024 Oct 9.
- Background: PubMed 38688998Hoban R, Gallipoli A, Signorile M, Mander P, Gauthier-Fisher A, Librach C, Wilson D, Unger S. Feasibility of intranasal human milk as stem cell therapy in preterm infants with intraventricular hemorrhage. J Perinatol. 2024 Nov;44(11):1652-1657. doi: 10.1038/s41372-024-01982-8. Epub 2024 Apr 30.
- Background: PubMed 30386923Keller T, Korber F, Oberthuer A, Schafmeyer L, Mehler K, Kuhr K, Kribs A. Intranasal breast milk for premature infants with severe intraventricular hemorrhage-an observation. Eur J Pediatr. 2019 Feb;178(2):199-206. doi: 10.1007/s00431-018-3279-7. Epub 2018 Nov 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Narvey principal investigator
University of Manitoba
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal Fresh Mother's Own Milk (iF-MOM) in people with Intraventricular Hemorrhage and Premature Birth, run by University of Manitoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Narvey (204-899-6845, mnarvey@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Any-Grade Intraventricular Hemorrhage (Papile Grades I-IV) (time frame: 4 to 7 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07812922, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.