An interventional study of Human breast milk in Intraventricular Hemorrhage, sponsored by The Hospital for Sick Children. Status unknown at 2 sites in Canada. Open to participants aged Up to 33 Weeks. Per ClinicalTrials.gov, last updated 2022-05-04.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Treatment
Intraventricular hemorrhage (IVH) is a leading cause of brain injury in infants born before term. Severe IVH, which occurs nearly exclusively in very preterm infants (born before 32 weeks gestation) who are already at risk of neurodevelopmental delays and cerebral palsy at baseline, results in a \~5 times higher risk of death or moderate-severe neurodevelopmental impairment, as well as short-term morbidities in the neonatal intensive care unit (NICU). Infants with grade I and II IVH, although less severe than the higher grades of IVH, also have a higher risk of death or moderate to severe neurodevelopmental impairment compared to infants with a normal head ultrasound. Outcomes are worsened by the fact that the brains of these preterm infants are not fully developed, so the progenitor cells that would later differentiate and mature are damaged, resulting in hypomyelination and gray matter loss that are associated with poor neurodevelopmental outcomes. There is no available therapy to treat the IVH or resultant brain injury, other than symptomatic management for resultant post-hemorrhagic hydrocephalus with lumbar punctures and temporary or permanent shunts, which have significant risks on their own.
This is a phase I trial to determine whether fresh intranasal human milk (HM) can be safely delivered as stem cell therapy to preterm IVH patients within a 3-hour window from HM expression and to identify signals which would indicate whether intranasal HM stimulates the repair of damaged brain tissue. Outcomes will be compared to HM fed historical IVH controls. Recruitment will take place in tertiary care NICUs in Toronto, which care for the highest proportion of very preterm infants with IVH in Canada. These NICUs have already adopted a common protocolized approach to manage severe IVH and post-hemorrhagic hydrocephalus with intensive monitoring, early symptomatic management, and detailed prospectively collected IVH data.
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's enrollment of 37 is below the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Human breast milk delivered intranasally to preterm infants (\<33 weeks gestation at birth, stratified \< and ≥28 weeks) with any grade IVH/intraparenchymal hemorrhage/infarction identified on head ultrasound in the first 10 days of life. Dosing: Escalating dose starting at 0.2mL into one nostril with repeat dose 10-15 minutes later 1-2x daily, depending on availability of fresh HM
Other: Human breast milk
Intranasal human breast milk
Number of participants with treatment-related adverse events as described in the protocol
Increased respiratory support settings or increase in Fio2 by more than 10% for more than 1 hour after the intervention, need for PPV/bagging immediately (within 5 minutes) of administration, or need for escalation of respiratory modality (ie NC to CPAP or NIV to intubation) in the hour after administration.
Time frame: 1 year
The number of participants with IVH related long-term adverse neurodevelopmental outcomes compared with a cohort of HM-fed historical controls with IVH from 30 months prior to the intervention cohort.
Cerebral Palsy, Gross motor delay (in the absence of CP), Fine motor delay, Vision impairment (blindness or wears glasses), Hearing impairment (aided / cochlear implant), Cognitive delay, Speech and language delay
Time frame: 2 years
Interference of IHM administration with routine clinical care measured using post-intervention staff survey
Time frame: 1 year
Number of participants with any grade IVH unable to be recruited within 10 days of birth
Time frame: 1 year
Number of eligible patients unable to receive intranasal HM administration within 3 hours of HM collection
Time frame: 1 year
Number of stem cells in maternal milk provided by lactating parents of preterm infants
Time frame: 1 year
Number of stem cells measured in CSF of treated infants who have lumbar punctures for clinical indications.
Time frame: 1 year
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children