Your session is about to expire
← Back to Search
Stem Cell Therapy
Human Breast Milk for Intraventricular Hemorrhage
N/A
Waitlist Available
Led By Rebecca Hoban, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether fresh, intranasal human milk can be safely delivered as stem cell therapy to preterm infants with IVH. If successful, this could potentially improve neurodevelopmental outcomes for these infants.
Eligible Conditions
- Intraventricular Hemorrhage
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with treatment-related adverse events as described in the protocol
Secondary study objectives
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.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intranasal human breast milkExperimental Treatment1 Intervention
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
Find a Location
Who is running the clinical trial?
MOUNT SINAI HOSPITALOTHER
42 Previous Clinical Trials
16,943 Total Patients Enrolled
The Hospital for Sick ChildrenLead Sponsor
708 Previous Clinical Trials
6,958,037 Total Patients Enrolled
Rebecca Hoban, MDPrincipal InvestigatorThe Hospital for Sick Children
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition that prevents treatment through the nose.You have a condition that affects your brain development, such as Down syndrome.You are currently participating in another study focused on how the brain develops.The infant is very sick and not expected to survive, and the medical team plans to focus on comfort care.If you are breastfeeding but are unable to pump milk at the study site or have fresh breast milk delivered by someone else at least once a day for 3 days, and if you live more than 30 kilometers away from the study site, you may not be able to participate.Babies born before 33 weeks of pregnancy with certain brain bleeding or injury within the first 10 days of life will not be included in the study. The specific criteria for the brain injury will be based on guidelines used by the study sites.
Research Study Groups:
This trial has the following groups:- Group 1: Intranasal human breast milk
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger