A Phase 2 interventional study of Dexmedetomidine Infusion and Morphine Infusion in Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy and Perinatal Anoxic-ischemic Brain Injury, sponsored by Ipsita Goswami. Not yet recruiting at 1 site in Canada. Open to participants aged Up to 20 Hours. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Ipsita Goswami · Phase 2, Interventional, and Treatment
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Among 19 studies in Hypoxia-Ischemia, Brain with a site in Canada — 10 open to participants now, 10 under way, none of them phase 3. Hypoxia-Ischemia, Brain · Canada.
Among the 19 studies in Hypoxia-Ischemia, Brain with a site in Canada, this one is the 6th largest by planned enrollment of the 14 interventional ones that give a count, is one of 4 that started in 2025, is one of 4 in phase 2, and was the 15th registered.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.
Browse Hypoxia-Ischemia, Brain studies →10 of the 19 studies in Hypoxia-Ischemia, Brain with a site in Canada are open now. Recruiting first, the newest first:
University of Alberta · Sites in Canada
Ages 1 days–1 days
McGill University Health Centre/Research Institute of the McGill University Health Centre · Sites in Canada
University of Calgary · Sites in Canada
Pia Wintermark · Sites in Canada, United States
Ages 0 min–48 hrs
Hamilton Health Sciences Corporation · Sites in Canada
Ages 1 days–15 days
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 60 Hypoxia-Ischemia, Brain studies recruiting now, 21 (35%) set no upper age limit and 37 (62%) stop at 75 or younger; 46 take children under 18; 7 take healthy volunteers.
This study: Up to 20 Hours · all sexes · no healthy volunteers.
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19 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is close to the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Median enrollment 42 across the 14 interventional studies, 50 across the 5 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
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1 of 19 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Ipsita Goswami as lead sponsor.
Ipsita Goswami has 1 study filed under Hypoxia-Ischemia, Brain — fewer than ten, so there is no comparison to draw.
2 of the studies in Hypoxia-Ischemia, Brain with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07829887University of CalgaryCerebral Oximetry in Management of Post Cardiac Arrest | 2027-02 |
| NCT06985290Ipsita GoswamiDexmedetomidine Versus Morphine During Cooling Therapy in Neonates | 2027-09-30 |
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Among the 19 studies in Hypoxia-Ischemia, Brain with a site in Canada, from their registry updates:
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About \~3/ 1000 live-born newborns may suffer from brain injury due to a transient drop in oxygen supply to the brain during the birth process. The degree of brain injury that ensues in the first 72 hours after the injury is directly proportional to the severity of long-term childhood disabilities (e.g., cerebral palsy and developmental delays). Whole-body cooling during the first 3 days of life is proven effective in reducing the severity of brain injury. However, cooling therapy leads to pain, shivering, stress, and discomfort. The best way to alleviate the pain and agitation of cooled newborns is unknown. Standard practice is to provide morphine infusion to reduce pain. Recently, a new drug called "dexmedetomidine" has been tested in small studies and has been found to be safe during cooling in newborns. Dexmedetomidine has added beneficial effects such as anti-inflammation, faster recovery, and shorter hospital stays. This study is going to test the feasibility of conducting a future clinical trial to compare the effects of using Dexmedetomidine versus morphine in the management of cooling-related pain/agitation on the severity of brain injury in the first week of life. The study will also examine the effect of dexmedetomidine compared to morphine on short-term clinical outcomes, parental experiences and developmental outcomes at 1 year.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dexmedetomidine infusion as sedation during therapeutic hypothermia and rewarming
Drug: Dexmedetomidine Infusion
Morphine infusion as sedative during therapeutic hypothermia and rewarming
Drug: Morphine Infusion
Dexmedetomidine infusion given for sedation during therapeutic hypothermia. Dexmedetomidine infusion at a starting dose of 0.2 μg/kg/h, with titration in 0.1 μg/kg/h increments with a maximum of 0.5 μg/kg/h based on objective assessment of sedation.
Morphine infusion given for sedation during therapeutic hypothermia. Morphine infusion at a starting dose of 4 μg/kg/h, with titration in 2 μg/kg/h increments with a maximum of 10 μg/kg/h based on objective assessment of sedation.
Recruitment Rate
Proportion of eligible neonates enrolled. Calculation = (Number of neonates enrolled) X 100/(Total eligible neonates)
Time frame: Day 1
Follow Up Rate
Percentage of neonates completing the study. Calculation = (Neonates who completed the study) x 100/ (Total neonates consented)
Time frame: From enrollment to 1 year of age
Adverse Event Rate
Incidence of adverse events Measurement of Adverse Event Rate = (Number of neonates experiencing) x100/ (Total neonates exposed to the intervention)
Time frame: From enrollment to 7 days of life
Discontinuation Rate
Need for intervention discontinuation due to adverse effects. Measurement of Discontinuation Rate = (Number of neonates for whom the intervention discontinued) x 100/ (Total neonates consented)
Time frame: From enrollment to 7 days of life
Protocol Adherence Rate
Percentage of correct drug adjustment based on changes in COMFORTneo scale as per protocol. Calculation of Drug Administration Compliance = (Number of correctly administered medication per month) x 100/ (Total number of participant enrolled per month)
Time frame: through study completion, average 1 year
Severity of Brain Injury on Magnetic Resonance Imaging (MRI)
The T1 and T2 weighted images, diffusion-weighted images, and magnetic resonance spectroscopy (MRS) are additionally evaluated to determine the level of brain damage. MRI scoring system reported by Weeke et al. will be used to classify brain injury based on 4 subscores, including grey matter (basal ganglia, thalamus, PLIC, brainstem, perirolandic cortex, and hippocampus), white matter/cortex (including optic radiation and corpus callosum), and cerebellum.
Time frame: From enrollment to 10 days of life
Seizure Burden during Therapeutic Hypothermia
Total duration of seizures noted during the first 72 hours of life
Time frame: From enrollment to 72 hours of life
Stress levels measured by Salivary cortisol assay at 24 and 48 hours
Salivary cortisol levels will be used as an objective marker of neonatal stress measured in µg/dL.
Time frame: From enrollment to 48 hours of life
Neonatal Sedation and Discomfort Levels
COMFORT neo scores during the period of therapeutic hypothermia. It consists of 7 behavioural items (alertness, calmness/agitation, respiratory response, crying, body movement, facial tension and muscle tone), of which six items should be scored (respiratory response or crying depends on the presence of invasive ventilation). The neonate will be observed for 2 minutes to score. Total scores range from 7 to 35. A score \>14 is considered a sign of distress and undersedation. A score \< 9 suggests oversedation.
Time frame: From enrollment to 4 days of life
Time to Reach Full Oral Feeds
Days of life when participant is receiving all oral feeds either breast or bottle
Time frame: up to 4 weeks of life
Cumulative dose of PRN opioid boluses given during therapeutic hypothermia
Total dose of morphine and fentanyl given during therapeutic hypothermia measured in mg/kg of morphine equivalent
Time frame: up to 4 days of life
Length of Hospital Stay
Day of life when discharged home
Time frame: up to 4 weeks of life
Days on invasive and non-invasive respiratory support
Day of life when comes off all respiratory support to room air
Time frame: Up to 4 weeks of life
Parental Stress Index
Parental Stress Index - Short Form (PSI-SF) will be administered to parents of study subjects at discharge from NICU to compare stress levels between neonates of the two groups. The short form is derived from the original Parental Stress Index (PSI). It consists of 36 items across three subscales namely (i) Parental Distress (PD): stress related to personal factors (e.g., depression, lack of support), (ii) Parent-Child Dysfunctional Interaction (P-CDI): stress about the child not meeting expectations and (iii) Difficult Child (DC): stress due to child's behavioral difficulties. Each item is rated 1 (Strongly Disagree) to 5 (Strongly Agree). Percentiles based on normative data are used to interpret scores. \>85th percentile indicates clinically significant stress, 90th-99th percentile indicates highly elevated stress.
Time frame: Up to 4 weeks of life
Parental Experiences
Parental experiences captured through semi-structured interviews will be audio-recorded and transcribed.
Time frame: From discharge to 4 weeks post-discharge
Developmental Outcomes at 12 months
Ages and Stages Questionnaire-3rd edition (ASQ-3) to assess five areas of childhood development: Communication, Gross motor, Fine motor, Problem-solving, and Personal-social through parent/caregiver reports. Each item is answered as Yes (10 points), Sometimes (5 points) and Not Yet (0 points). Each domain has 6 questions, hence a maximum 60 points per domain. After summing scores for each domain, total score is interpretated as: (i) Above Cutoff (Development is on schedule), (ii) Close to Cutoff (within 1 SD) (Monitor, Child may need re-screening soon) and (iii) Below Cutoff (Referral to specialist for further evaluation recommended).
Time frame: Between 10-14 months of enrollment
Plan to share: Yes — De-identified individual participant data (IPD) will be shared with qualified researchers following publication of the primary study results. Data sharing will comply with applicable privacy regulations (e.g., PIPEDA/PHIPA).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be available beginning 12 months after publication of the primary results or within 18 months of primary study completion, whichever occurs first. Data will be available for at least 5 years thereafter.
Access criteria: Researchers must submit a scientifically sound proposal. Access will be granted upon approval by the Data Access Committee and signing of a Data Use Agreement (DUA). Data must be used for secondary analyses, meta-analyses, or validation studies. Re-identification attempts are prohibited.
Start is estimated for Jul 2025; primary completion for Sep 2027, 26 months later.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Dexmedetomidine