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Intranasal Human Milk for Intraventricular Hemorrhage

Primary Purpose

Intraventricular Hemorrhage

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Human breast milk
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraventricular Hemorrhage

Eligibility Criteria

undefined - 33 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Preterm infants (<33 weeks gestation at birth, stratified < and ≥28 weeks) with any grade IVH/intraparenchymal hemorrhage/infarction on head ultrasound in the first 10 days of life. Diagnostic criteria will be based on the Papile definitions as used by the study sites/Toronto Centre for Neonatal Health for PHVD management, outlined in the document "Intraventricular Hemorrhage and Measurements of Lateral Ventricular Size from Head Ultrasound"

Exclusion Criteria:

  1. Disorders associated with neurodevelopmental delays or impairment (i.e. Trisomy 21)
  2. Moribund/critically ill infant or known lethal diagnosis with plans by medical team to redirect care
  3. Choanal atresia or anomalies that would not allow intranasal treatment
  4. Surgical condition (e.g. esophageal atresia) for which team feels intranasal HM is contraindicated
  5. Enrolled in other intervention trials in which primary target is neurodevelopmental outcome
  6. Parent with lactation contraindication(s) (i.e. HIV) or parent who declines lactation initiation
  7. Lactating parent unable to provide fresh HM: unable/unwilling to pump at study site or unable to have fresh HM delivered by designee at least once/day for 3 days within 3 hours of pumping AND located (in hospital or home) >30km from study sites (for courier services)

Sites / Locations

  • Mount Sinai Hospital
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intranasal human breast milk

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Interference of IHM administration with routine clinical care measured using post-intervention staff survey
Number of participants with any grade IVH unable to be recruited within 10 days of birth
Number of eligible patients unable to receive intranasal HM administration within 3 hours of HM collection

Full Information

First Posted
December 20, 2019
Last Updated
May 3, 2022
Sponsor
The Hospital for Sick Children
Collaborators
MOUNT SINAI HOSPITAL
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1. Study Identification

Unique Protocol Identification Number
NCT04225286
Brief Title
Intranasal Human Milk for Intraventricular Hemorrhage
Official Title
Intranasal Human Milk as Stem Cell Therapy in Preterm Infants With Intraventricular Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
MOUNT SINAI HOSPITAL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraventricular Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intranasal human breast milk
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Human breast milk
Intervention Description
Intranasal human breast milk
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as described in the protocol
Description
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
Secondary Outcome Measure Information:
Title
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.
Description
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
Title
Interference of IHM administration with routine clinical care measured using post-intervention staff survey
Time Frame
1 year
Title
Number of participants with any grade IVH unable to be recruited within 10 days of birth
Time Frame
1 year
Title
Number of eligible patients unable to receive intranasal HM administration within 3 hours of HM collection
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Number of stem cells in maternal milk provided by lactating parents of preterm infants
Time Frame
1 year
Title
Number of stem cells measured in CSF of treated infants who have lumbar punctures for clinical indications.
Time Frame
1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Preterm infants (<33 weeks gestation at birth, stratified < and ≥28 weeks) with any grade IVH/intraparenchymal hemorrhage/infarction on head ultrasound in the first 10 days of life. Diagnostic criteria will be based on the Papile definitions as used by the study sites/Toronto Centre for Neonatal Health for PHVD management, outlined in the document "Intraventricular Hemorrhage and Measurements of Lateral Ventricular Size from Head Ultrasound" Exclusion Criteria: Disorders associated with neurodevelopmental delays or impairment (i.e. Trisomy 21) Moribund/critically ill infant or known lethal diagnosis with plans by medical team to redirect care Choanal atresia or anomalies that would not allow intranasal treatment Surgical condition (e.g. esophageal atresia) for which team feels intranasal HM is contraindicated Enrolled in other intervention trials in which primary target is neurodevelopmental outcome Parent with lactation contraindication(s) (i.e. HIV) or parent who declines lactation initiation Lactating parent unable to provide fresh HM: unable/unwilling to pump at study site or unable to have fresh HM delivered by designee at least once/day for 3 days within 3 hours of pumping AND located (in hospital or home) >30km from study sites (for courier services)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Hoban, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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Intranasal Human Milk for Intraventricular Hemorrhage

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