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
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.
Exclusion criteria:
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, Sap, Icf, Csr
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.