Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants

NCT07812922 | Not Yet Recruiting DMC

• 1 other identifier: iF-MOM-IVH
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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; Colostrum; iF-MOM

Outcome Measures

Primary Outcomes (1)

• 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.

  4 to 7 days of life

Secondary Outcomes (5)

• Incidence of Severe Intraventricular Hemorrhage (Papile Grades III-IV)

  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

  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

  From the initial cranial ultrasound performed at 4-7 days of life through hospital discharge, up to 6 months of life

• All-Cause Mortality

  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

  During the 7-day intervention period

Study Arms (1)

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.

Other: Intranasal Fresh Mother's Own Milk (iF-MOM)

Interventions

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.

iF-MOM Intervention

Eligibility Criteria

• Age: 0 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Related Publications (5)

• 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.

  PMID: 39786414 BACKGROUND

• Sonmez 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.

  PMID: 40213722 BACKGROUND

• Gallipoli 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.

  PMID: 39384614 BACKGROUND

• Hoban 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.

  PMID: 38688998 BACKGROUND

• Keller 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.

  PMID: 30386923 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Michael Narvey

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Narvey

CONTACT

204-899-6845; mnarvey@hsc.mb.ca

Mohamed Habib

CONTACT

4319988002; mustchange84@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Pediatrics and Child Health

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 10, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share