Hypoxic Ischemic Encephalopathy of NewbornPhase 1NCT05590676
Metformin Treatment in Infants After Perinatal Brain Injury
A Phase 1 study testing Metformin Hydrochloride in people with Hypoxic Ischemic Encephalopathy of Newborn and Premature Birth, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy of Newborn, Premature Birth
- What is being tested?
- Metformin Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 2 May 2023to 22 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- HIE Patients:
- > 35 weeks gestation at time of birth
- ≤3 months at time of consent
- Clinical diagnosis of HIE
- Infant received therapeutic hypothermia for the treatment of HIE
- Family lives within one hour distance of the Hospital for Sick Children (in order to facilitate home visits)
Show all 10Show fewer
- Preterm Infants:
- <32 weeks gestation at time of birth
- 36-44 weeks corrected (postmenstrual) gestational age at time of metformin administration
- Clinical team anticipates hospitalization at SickKids for at least 1 week after study enrollment
Who cannot join
- Have a known genetic or chromosomal disorder.
- Congenital or acquired liver or kidney disease that might, in the opinion of the Principal Investigator or delegate, affect drug metabolism.
- History of hypoglycemia in the newborn period requiring glucose infusion rate > 10 mg/kg/min or treatment with glucagon or diazoxide.
- Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate, interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
- >3 months of age at the time of enrollment (term HIE patients only)
- Weight <10%ile based on WHO growth charts at time of initiation of study drug (term HIE patients only).
- Maternal use of metformin while actively breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Safety and Feasibility of Metformin Treatment in Infants After Perinatal Brain Injury
A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury
- Being tested
- Metformin Hydrochloride
- Keywords
- Hypoxic Ischemic Encephalopathy, Newborn, Metformin, Prematurity
- Medical subject headings
- Premature Birth, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin HydrochlorideDrug
Infants will receive 14 consecutive doses, once daily, of metformin, with two dose cohorts.
Arm 1: Five infants with HIE will be enrolled on the first dose cohort of 20 mg/kg. Once complete, another five infants will be enrolled on the second dose cohort of 25 mg/kg.
Arm 2: Five preterm infants will be enrolled on the first dose cohort of 15 mg/kg. Once complete, another five preterm infants will be enrolled on the second dose cohort of 20 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| HIE: 20 mg/kg | Experimental | Not described Receives: Drug: Metformin Hydrochloride |
| HIE: 25 mg/kg | Experimental | Not described Receives: Drug: Metformin Hydrochloride |
| Preterm: 15 mg/kg | Experimental | Not described Receives: Drug: Metformin Hydrochloride |
| Preterm: 20 mg/kg | Experimental | Not described Receives: Drug: Metformin Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with hypoglycemia (serum glucose <3.3mmol/L)
Number of patients with hyperglycemia (glucose>10mmol/L)
Measured: 2 weeks
Secondary outcomes (3)
Plasma metformin levels
Pharmacokinetics analysis
Measured: 2 weeks
Number of patients who complete study
Feasibility of study intervention administration
Measured: 2 weeks
Number of patients who complete all study procedures
Feasibility of executing study operations
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start2 May 2023
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic Ischemic Encephalopathy of NewbornStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- University of Waterloo, University of Alberta
- Responsible party
- Principal investigator, Brian Kalish, The Hospital for Sick Children
- Investigators
- Brian T Kalish, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590676
- Sponsor's protocol ID
- 3987
- Status last verified
- Mar 2024
- First submitted
- 18 Oct 2022
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety and Feasibility of Metformin Treatment in Infants After Perinatal Brain Injury
- ClinicalTrials.gov ID
- NCT05590676
- Acronym / sponsor ID
- 3987
- Keywords
- Hypoxic Ischemic Encephalopathy, Newborn, Metformin, Prematurity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- University of Waterloo, University of Alberta
- Study start
- 2 May 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase I study to test the feasibility and safety of treatment with metformin in infants affected by hypoxic ischemic encephalopathy (HIE) or prematurity-related brain injury
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIE: 20 mg/kg | Experimental | Drug: Metformin Hydrochloride |
| HIE: 25 mg/kg | Experimental | Drug: Metformin Hydrochloride |
| Preterm: 15 mg/kg | Experimental | Drug: Metformin Hydrochloride |
| Preterm: 20 mg/kg | Experimental | Drug: Metformin Hydrochloride |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- > 35 weeks gestation at time of birth
- ≤3 months at time of consent
- Clinical diagnosis of HIE
- Infant received therapeutic hypothermia for the treatment of HIE
- Family lives within one hour distance of the Hospital for Sick Children (in order to facilitate home visits)
Key exclusion criteria (7 listed)
- Have a known genetic or chromosomal disorder.
- Congenital or acquired liver or kidney disease that might, in the opinion of the Principal Investigator or delegate, affect drug metabolism.
- History of hypoglycemia in the newborn period requiring glucose infusion rate > 10 mg/kg/min or treatment with glucagon or diazoxide.
- Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate, interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
- >3 months of age at the time of enrollment (term HIE patients only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin HydrochlorideInfants will receive 14 consecutive doses, once daily, of metformin, with two dose cohorts. Arm 1: Five infants with HIE will be enrolled on the first dose cohort of 20 mg/kg. Once complete, another five infants will be enrolled on the second dose cohort of 25 mg/kg. Arm 2: Five preterm infants will be enrolled on the first dose cohort of 15 mg/kg. Once complete, another five preterm infants will be enrolled on the second dose cohort of 20 mg/kg. | Drug | HIE: 20 mg/kg, HIE: 25 mg/kg, Preterm: 15 mg/kg, Preterm: 20 mg/kg |
Primary outcome
Number of patients with hypoglycemia (serum glucose <3.3mmol/L)
Time frame: 2 weeks
Number of patients with hyperglycemia (glucose>10mmol/L)
3 secondary outcomes
Plasma metformin levels
Time frame: 2 weeks
Number of patients who complete study
Time frame: 2 weeks
Number of patients who complete all study procedures
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian T Kalish, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin Hydrochloride in people with Hypoxic Ischemic Encephalopathy of Newborn and Premature Birth, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with hypoglycemia (serum glucose <3.3mmol/L) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.