[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655377":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":40,"studyPopulation":32,"armGroups":41,"interventions":48,"overallOfficials":53,"centralContacts":57,"locations":32,"responsibleParty":66,"collaborators":32,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":32,"studyType":82,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":99,"whyStopped":32,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":32},{"fullName":5,"class":6},"University of Manitoba","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,21,24,28],{"measure":15,"description":16,"timeFrame":17},"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.","From the initial cranial ultrasound performed at 4-7 days of life through hospital discharge, up to 6 months of life",{"measure":19,"description":20,"timeFrame":17},"Progression of Intraventricular Hemorrhage","Worsening of IVH grade on repeat cranial ultrasound compared with the initial day 4-7 cranial ultrasound.",{"measure":22,"description":23,"timeFrame":17},"Post-Hemorrhagic Ventricular Dilatation Requiring Intervention","Development of post-hemorrhagic ventricular dilatation requiring clinical or neurosurgical intervention, including ventriculoperitoneal shunt when applicable.",{"measure":25,"description":26,"timeFrame":27},"All-Cause Mortality","Death from any cause occurring before hospital discharge.","From birth until death or hospital discharge, whichever occurs first, assessed up to 6 months of life",{"measure":29,"description":30,"timeFrame":31},"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.","During the 7-day intervention period",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"NA","SINGLE_GROUP","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.","PREVENTION",{"masking":39,"maskingDescription":32,"whoMasked":32},"NONE","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.\n\nFresh 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.\n\nThis 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.\n\nFresh 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.\n\nInfants 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.\n\nThe 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.\n\nThe 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.\n\nBecause 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.\n\nAn 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.",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"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\u002Fstudy clinical team. Intranasal administrations will occur 2-4 times daily, coordinated around routine nursing care, for 7 consecutive days.",[47],"Other: Intranasal Fresh Mother's Own Milk (iF-MOM)",[49],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":32},"Intranasal Fresh Mother's Own Milk (iF-MOM)","Fresh breast milk from the infant's own mother\u002Fbirthing 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.",[43],[54],{"name":55,"affiliation":5,"role":56},"Michael Narvey","PRINCIPAL_INVESTIGATOR",[58,62],{"name":55,"role":59,"phone":60,"phoneExt":32,"email":61},"CONTACT","204-899-6845","mnarvey@hsc.mb.ca",{"name":63,"role":59,"phone":64,"phoneExt":32,"email":65},"Mohamed Habib","4319988002","mustchange84@gmail.com",{"type":56,"investigatorFullName":55,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Associate Professor, Department of Pediatrics and Child Health","100655377","intranasal-fresh-mothers-own-milk-to-prevent-intraventricular-hemorrhage-in-extremely-preterm-infants-100655377",false,"NCT07812922","Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants","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","iF-MOM-IVH","Inclusion Criteria:\n\n1. Gestational age ≤29+0 weeks based on the best obstetric estimate, with first-trimester ultrasound preferred.\n2. Inborn at Women's Hospital or St. Boniface Hospital, Winnipeg, Manitoba, Canada.\n3. Written informed consent obtained from a parent or legal guardian; antenatal consent may be obtained when preterm delivery is anticipated.\n4. Mother\u002Fbirthing 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.\n5. Enrollment within 72 hours of life.\n\nExclusion Criteria:\n\n1. Major congenital brain malformation, including holoprosencephaly, lissencephaly, schizencephaly, severe primary hydrocephalus, large arachnoid cyst, or other space-occupying lesion.\n2. Airway or nasal anomaly precluding intranasal administration, including choanal atresia\u002Fstenosis, severe cleft palate\u002Flip with nasal involvement, or Pierre Robin sequence with severe obstruction.\n3. Trisomy 13, Trisomy 18, or another severe chromosomal\u002Fgenetic disorder.\n4. Acute surgical condition requiring immediate intervention, such as esophageal atresia with tracheoesophageal fistula.\n5. Life-limiting condition, including comfort-care designation, anticipated survival \\\u003C72 hours, known lethal diagnosis such as bilateral renal agenesis or anencephaly, or severe birth asphyxia with anticipated poor neurologic outcome.\n6. Maternal contraindication to lactation, including HIV, or inability\u002Funwillingness to provide fresh mother's own milk.\n7. Evidence of Grade III-IV intraventricular hemorrhage on cranial ultrasound before enrollment.\n8. Absence of fresh own-mother\u002Fbirthing-parent milk for study dosing, including circumstances in which only donor or surrogate-provided milk is available.","ALL","0 Hours","72 Hours",{"count":80,"type":81},67,"ESTIMATED","INTERVENTIONAL",[34],"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.\n\nThis 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.\n\nApproximately 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.\n\nThe 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.\n\nOutcomes 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.",[86,87],"Intraventricular Hemorrhage","Premature Birth",[89,90,91,92,93,94,95,96,97,98],"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","NOT_YET_RECRUITING","2026-09-04",{"date":102,"type":103},"2026-09-10","ACTUAL",{"date":105,"type":81},"2026-10",{"date":107,"type":81},"2028-04",{"name":5,"class":6}]