Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-72
SponsorUniversity of Manitoba
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Intranasal Fresh Mother's Own Milk (iF-MOM)
Other interventionFresh 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.
Treatment groups
67 Participants
are divided into 1 treatment groupGroup A: iF-MOM InterventionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
4 to 7 days of lifeSecondary outcomes
1
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.
Time frame
From the initial cranial ultrasound performed at 4-7 days of life through hospital discharge, up to 6 months of life2
Progression of Intraventricular Hemorrhage
Worsening of IVH grade on repeat cranial ultrasound compared with the initial day 4-7 cranial ultrasound.
Time frame
From the initial cranial ultrasound performed at 4-7 days of life through hospital discharge, up to 6 months of life3
Post-Hemorrhagic Ventricular Dilatation Requiring Intervention
Development of post-hemorrhagic ventricular dilatation requiring clinical or neurosurgical intervention, including ventriculoperitoneal shunt when applicable.
Time frame
From the initial cranial ultrasound performed at 4-7 days of life through hospital discharge, up to 6 months of life4
All-Cause Mortality
Death from any cause occurring before hospital discharge.
Time frame
From birth until death or hospital discharge, whichever occurs first, assessed up to 6 months of lifeLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: