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
Study 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related adverse events as described in the protocol
Secondary outcome measures
Interference of IHM administration with routine clinical care measured using post-intervention staff survey
Number of eligible patients unable to receive intranasal HM administration within 3 hours of HM collection
Number of participants with any grade IVH unable to be recruited within 10 days of birth
+1 moreOther outcome measures
Number of stem cells in maternal milk provided by lactating parents of preterm infants
Number of stem cells measured in CSF of treated infants who have lumbar punctures for clinical indications.
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
40 Previous Clinical Trials
14,594 Total Patients Enrolled
The Hospital for Sick ChildrenLead Sponsor
687 Previous Clinical Trials
6,944,996 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any additional participants being welcomed into the research project at this time?
"Clinicaltrials.gov states that no new recruits are being accepted for this trial, which started on March 11th 2020 and was last updated May 3rd 2022. Despite these facts, 366 other trials remain open to enrolment at present."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger