Hypoxic-ischemic Encephalopathy (HIE)Phase 2PROTECT-HIENCT07406477
The PROTECT-HIE Pilot Trial
A Phase 2 study testing Dobutamine and TnECHO in people with Hypoxic-ischemic Encephalopathy (HIE), run by University of Alberta at 2 sites in Canada.
Trial summary
Some babies experience a lack of oxygen and blood flow around the time of birth. This can lead to a serious condition called hypoxic-ischemic encephalopathy (HIE), which can injure the brain and other organs, including the heart. Read more about this study
- Who is it for?
- Ages 1 to 1 day
- Conditions the study is for
- Hypoxic-ischemic Encephalopathy (HIE)
- What is being tested?
- Dobutamine and TnECHO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Oct 2026to 30 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 1 to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with hypoxemic ischemic encephalopathy (HIE) receiving therapeutic hypothermia (TH).
Who cannot join
- Congenital abnormality
- known contraindication of dobutamine
- Left ventricular outflow tract dynamic obstruction
- Hypersensitivity to dobutamine
- Uncorrected tachyarrhythmias or ventricular fibrillation
- Newborns who are already started on inotropes at the time of randomization.
- Parental refusal to consent to participate
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Philip C. Etches Neonatal Intensive Care Unit (Royal Alexandra Hospital)
Edmonton, Alberta
Aimann Surak, MD FRCPC DRCPSC, 7807354647, aimann@ualberta.ca
- Not yet recruiting
Royal Alexandra Hospital
Edmonton, Alberta
Aimann Surak, MD FRCPC, 7807354647, aimann@ualberta.ca
About this study
Official title: The PROTECT-HIE Pilot Trial: Prophylactic Therapy to Enhance Cardiovascular Treatment in Neonatal Hypoxemic Ischemic Encephalopathy
Some babies experience a lack of oxygen and blood flow around the time of birth. This can lead to a serious condition called hypoxic-ischemic encephalopathy (HIE), which can injure the brain and other organs, including the heart. To reduce brain injury, babies with HIE are treated with therapeutic hypothermia, a standard treatment in which the baby's body temperature is carefully lowered for several days. While cooling helps protect the brain, many babies with HIE still develop heart problems and low blood flow, which may worsen outcomes.
Doctors often use medications to support the heart and circulation in these babies, but there is no clear agreement on which medication works best or when it should be started. One commonly used medication is dobutamine, which helps the heart pump more effectively. Dobutamine is already used in newborn intensive care units when babies show signs of heart weakness, but it is usually started only after problems develop.
Read more
The PROTECT-HIE trial aims to find out whether it is possible and safe to start dobutamine early, before clear signs of heart failure appear, in newborns with HIE who are receiving therapeutic hypothermia. The idea is that early support of the heart may improve blood flow to vital organs, including the brain, and potentially reduce injury.
In this study, 40 newborns with HIE will take part at a single neonatal intensive care unit. Babies will be randomly assigned to one of two groups. One group will receive a low, preventative dose of dobutamine within the first four hours after cooling begins. The other group will receive a placebo (an inactive fluid that looks the same). Neither the families nor the medical team assessing outcomes will know which treatment the baby received.
The main goal of this study is to determine feasibility-that is, whether starting dobutamine early during cooling can be done reliably and safely in this setting. Researchers will also collect information on important health outcomes, such as signs of brain injury on MRI, seizures, need for additional heart medications, heart function on ultrasound, recovery of blood markers, urine output, length of hospital stay, and survival.
Because HIE is an emergency condition and treatment must start very soon after birth, parents will be approached for consent after the baby has been stabilized. This approach is commonly used in neonatal emergency research and has been approved in similar studies.
The results of this study will help determine whether a larger trial should be done in the future. Ultimately, this research aims to improve care and outcomes for babies affected by HIE by optimizing support for the heart during a critical period after birth.
Read the detailed description
Purpose
The purpose of this study is to evaluate the feasibility and safety of initiating prophylactic dobutamine infusion in newborns with hypoxic-ischemic encephalopathy (HIE) who are undergoing therapeutic hypothermia (TH). Infants with HIE frequently experience cardiovascular instability during the early postnatal period, which may negatively affect cerebral perfusion and overall outcomes. This study aims to determine whether early, preventive cardiovascular support can be reliably implemented and whether it may be associated with improved short-term clinical outcomes.
Hypothesis
The primary hypothesis is that initiating prophylactic dobutamine infusion within the first four hours of therapeutic hypothermia in newborns with HIE is feasible and safe.
The secondary hypothesis is that early dobutamine prophylaxis may be associated with improved short-term in-hospital outcomes, including reduced severity of brain injury, improved cardiac function, and reduced need for escalation of cardiovascular support.
Justification
HIE remains a major cause of neonatal mortality and long-term neurodevelopmental impairment despite the widespread use of therapeutic hypothermia. Up to 80% of infants with HIE experience some degree of cardiovascular compromise, particularly involving right ventricular dysfunction, which has been associated with worse neurological outcomes and increased mortality.
Although vasoactive medications are frequently used in this population, there is no standardized or evidence-based approach regarding the optimal agent or timing of initiation. Dobutamine is a commonly used inotropic agent in neonates, with a favorable physiological profile that enhances cardiac contractility without significant increases in heart rate or systemic vascular resistance. Preliminary observational data suggest that dobutamine improves cardiac output in infants with HIE undergoing hypothermia.
Currently, dobutamine is typically initiated only after cardiovascular compromise becomes clinically apparent. A prophylactic approach, initiated early during therapeutic hypothermia, may help stabilize cardiac function, optimize systemic and cerebral perfusion, and potentially reduce secondary brain injury. Before a definitive efficacy trial can be conducted, it is necessary to establish the feasibility, safety, and protocol adherence of such an intervention. This pilot randomized controlled trial is designed to address that critical knowledge gap.
Objectives
Primary Objective
To determine the feasibility of initiating prophylactic dobutamine infusion within the first four hours of starting therapeutic hypothermia in newborns with HIE.
Secondary Objectives
To explore whether prophylactic dobutamine is associated with improved short-term clinical outcomes, including:
Presence and severity of brain injury on MRI Mortality Seizure activity (clinical or electrographic) Need for escalation of inotropic or vasoactive support Echocardiographic measures of cardiac function and pulmonary hemodynamics Time to normalization of lactate Duration of inhaled nitric oxide therapy, if required Urine output at 24, 48, and 72 hours Length of hospital stay until discharge or death Research Method / Procedures
This study is a single-center, double-blinded, randomized controlled feasibility trial conducted in a tertiary neonatal intensive care unit.
Eligible participants are newborns diagnosed with hypoxic-ischemic encephalopathy who are receiving therapeutic hypothermia. Infants will be excluded if they have congenital anomalies, contraindications to dobutamine, significant arrhythmias, or if they have already been started on inotropic support prior to randomization.
Participants will be randomized in a 1:1 ratio to either:
Intervention group: Prophylactic dobutamine infusion at 10 mcg/kg/min Control group: Placebo infusion (dextrose 5%) identical in appearance and administration Randomization will be computer-generated, with allocation concealment ensured through a secure REDCap system. The study will be double-blinded; parents, clinical staff, outcome assessors, and data analysts will remain unaware of group assignment until completion of the final analysis.
The assigned infusion (dobutamine or placebo) will be initiated within four hours of starting therapeutic hypothermia and continued until clinical improvement, escalation of cardiovascular support, or weaning at the discretion of the clinical team.
All participants will undergo standardized targeted neonatal echocardiography at two predefined time points during the first 48 hours. Clinical data will be collected throughout hospitalization, including laboratory results, imaging findings, medication use, adverse events, and outcomes.
Due to the emergency nature of HIE and the need for timely initiation of treatment, a deferred consent model will be used. Parents of surviving infants will be approached for written consent as soon as feasible after stabilization and prior to discharge. For infants who die before consent can be obtained, a waiver of consent will be requested for collection of minimal anonymized data.
Plan for Data Analysis
The primary analysis will focus on feasibility outcomes, including:
Proportion of eligible infants successfully receiving the intervention within four hours of initiating therapeutic hypothermia Protocol adherence rate The study will be considered feasible if more than 60% of eligible infants are recruited and more than 75% of randomized infants receive the assigned intervention without major protocol deviations.
Secondary clinical outcomes will be analyzed descriptively, as this pilot study is not powered to detect definitive efficacy differences. Continuous variables will be summarized using means, standard deviations, medians, and interquartile ranges as appropriate. Categorical variables will be reported as frequencies and percentages.
Comparisons between groups will be conducted using:
Student's t-test or Mann-Whitney U test for continuous variables Chi-square test for categorical variables All analyses will follow the intention-to-treat principle. Statistical significance will be defined as a two-sided p-value <0.05. Analyses will be performed using IBM SPSS and SAS statistical software after database lock and unblinding.
- Conditions
- Hypoxic-ischemic Encephalopathy (HIE)
- Being tested
- Dobutamine, TnECHO
- Keywords
- Hypoxic-ischemic encephalopathy, feasibility RCT, neonatal cardiac dysfunction, prophylactic inotrope, therapeutic hypothermia, neonatal HIE, dobutamine
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DobutamineDrug
If randomized to the prophylaxis/dobutamine arm, dobutamine will be administered at a dose of 10 mcg/kg/min via intravenous access within 4 hours of initiating TH. As a part of standard care for HIE, a central umbilical venous access is routinely acquired whenever possible. We will use the dobutamine concentration of 2000 mcg/ml. The infusion will be prepared in dextrose 5% solution in 50 mL bags. Dobutamine monograph is attached to the protocol as well (Appendix F). The infusion will be continued until either weaned by the clinical team, escalation of inotropic support, or improvement of clinical situation to allow weaning of dobutamine.
TnECHODiagnostic test
In both groups, 2 TnECHOs will be performed. TnECHO T1 will be performed within the 24 hours of randomization, and TnECHO T2 will be performed within 24-48 hours after TnECHO T1. All echocardiographic assessments are done by physicians trained in TnECHO or by pediatric cardiology team. Echocardiographic assessment will be performed as per the American Society or Echocardiography guidelines(63-66). Details of the standardised echo views and measurements are outlined in Appendix B.
| Study group | Role | What they receive |
|---|---|---|
| Dobutamine group | Experimental | If randomized to the prophylaxis/dobutamine arm, dobutamine will be administered at a dose of 10 mcg/kg/min via intravenous access within 4 hours of initiating TH. As a part of standard care for HIE, a central umbilical venous access is routinely acquired whenever possible. We will use the dobutamine concentration of 2000 mcg/ml. The infusion will be prepared in dextrose 5% solution in 50 mL bags. Dobutamine monograph is attached to the protocol as well (Appendix F). The infusion will be continued until either weaned by the clinical team, escalation of inotropic support, or improvement of clinical situation to allow weaning of dobutamine. Receives: Drug: Dobutamine; Diagnostic Test: TnECHO |
| Control group | Placebo comparator | Infants randomized to the placebo arm will receive an inert preparation containing no active pharmacologic agent. The placebo will be identical in appearance, volume, and method of administration to the active intervention and will be administered according to the same dosing schedule and duration. We will use dextrose 5% (as placebo), which will be started within 4 hours of initiating TH. The infusion will be continued until either weaned by the clinical team, escalation of inotropic support, or improvement of clinical situation to allow weaning of dobutamine. Receives: Diagnostic Test: TnECHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility/Safety
Proportion of eligible infants receiving the intervention (or placebo) within 4 hours of initiating TH
Measured: At 24 hours of age
Secondary outcomes (12)
Brain injury
Brain injury on MRI (normal/abnormal)
Measured: through study completion, an average of 1 month
Severity and type of brain injury
Severity and type of brain injury on head MRI [as per reference # 72 in the uploaded protocol, Mohammad K, et al. Consensus Approach for Standardization of the Timin]
Measured: through study completion, an average of 1 month
Mortality
Death (yes/no)
Measured: through study completion, an average of 1 month
Seizure activity
Presence of seizure activity either clinically or on EEG (yes/no)
Measured: through study completion, an average of 1 month
Need for escalation the inotropic support
Need for escalation the inotropic support (beyond the above-mentioned infusions) (yes/no)
Measured: through study completion, an average of 1 month
TAPSE in mm
Echocardiographic parameter
Measured: through study completion, an average of 1 month
RV FAC in %
Echocardiographic parameter
Measured: through study completion, an average of 1 month
LV EF in %
Echocardiographic parameter
Measured: through study completion, an average of 1 month
Time to normalizing lactate in hours
Time to normalizing lactate reported in hours (the cutoff for normal lactate is 3 as per local laboratory values)
Measured: through study completion, an average of 1 month
Duration of inhaled nitric oxide in hours
Duration of inhaled nitric oxide if needed reported in hours from the time of initiation to time of discontinuation
Measured: through study completion, an average of 1 month
Urine output in cc/k/hour
Urine output reported at 24, 48, and 72 hours reported in cc/k/hour
Measured: through study completion, an average of 1 month
Length of hospital stay in days
Length of stay in hospital in days defined from the date of birth till the date of discharge/death
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start13 Oct 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-ischemic Encephalopathy (HIE)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406477
- Sponsor's protocol ID
- Pro00162062
- Acronym
- PROTECT-HIE
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect patient confidentiality. However, this could be re-considered if ethics approval is obtained from the requesting researcher and also the source ethics board.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PROTECT-HIE Pilot Trial: Prophylactic Therapy to Enhance Cardiovascular Treatment in Neonatal Hypoxemic Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT07406477
- Acronym / sponsor ID
- PROTECT-HIE / Pro00162062
- Conditions
- Hypoxic-ischemic Encephalopathy (HIE)
- Keywords
- Hypoxic-ischemic encephalopathy, feasibility RCT, neonatal cardiac dysfunction, prophylactic inotrope, therapeutic hypothermia, neonatal HIE, dobutamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 13 Oct 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 12 Feb 2026 (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.
Some babies experience a lack of oxygen and blood flow around the time of birth. This can lead to a serious condition called hypoxic-ischemic encephalopathy (HIE), which can injure the brain and other organs, including the heart. To reduce brain injury, babies with HIE are treated with therapeutic hypothermia, a standard treatment in which the baby's body temperature is carefully lowered for several days. While cooling helps protect the brain, many babies with HIE still develop heart problems and low blood flow, which may worsen outcomes.
Doctors often use medications to support the heart and circulation in these babies, but there is no clear agreement on which medication works best or when it should be started. One commonly used medication is dobutamine, which helps the heart pump more effectively. Dobutamine is already used in newborn intensive care units when babies show signs of heart weakness, but it is usually started only after problems develop.
The PROTECT-HIE trial aims to find out whether it is possible and safe to start dobutamine early, before clear signs of heart failure appear, in newborns with HIE who are receiving therapeutic hypothermia. The idea is that early support of the heart may improve blood flow to vital organs, including the brain, and potentially reduce injury.
In this study, 40 newborns with HIE will take part at a single neonatal intensive care unit. Babies will be randomly assigned to one of two groups. One group will receive a low, preventative dose of dobutamine within the first four hours after cooling begins. The other group will receive a placebo (an inactive fluid that looks the same). Neither the families nor the medical team assessing outcomes will know which treatment the baby received.
The main goal of this study is to determine feasibility-that is, whether starting dobutamine early during cooling can be done reliably and safely in this setting. Researchers will also collect information on important health outcomes, such as signs of brain injury on MRI, seizures, need for additional heart medications, heart function on ultrasound, recovery of blood markers, urine output, length of hospital stay, and survival.
Because HIE is an emergency condition and treatment must start very soon after birth, parents will be approached for consent after the baby has been stabilized. This approach is commonly used in neonatal emergency research and has been approved in similar studies.
The results of this study will help determine whether a larger trial should be done in the future. Ultimately, this research aims to improve care and outcomes for babies affected by HIE by optimizing support for the heart during a critical period after birth.
Detailed description
Purpose
The purpose of this study is to evaluate the feasibility and safety of initiating prophylactic dobutamine infusion in newborns with hypoxic-ischemic encephalopathy (HIE) who are undergoing therapeutic hypothermia (TH). Infants with HIE frequently experience cardiovascular instability during the early postnatal period, which may negatively affect cerebral perfusion and overall outcomes. This study aims to determine whether early, preventive cardiovascular support can be reliably implemented and whether it may be associated with improved short-term clinical outcomes.
Hypothesis
The primary hypothesis is that initiating prophylactic dobutamine infusion within the first four hours of therapeutic hypothermia in newborns with HIE is feasible and safe.
The secondary hypothesis is that early dobutamine prophylaxis may be associated with improved short-term in-hospital outcomes, including reduced severity of brain injury, improved cardiac function, and reduced need for escalation of cardiovascular support.
Justification
HIE remains a major cause of neonatal mortality and long-term neurodevelopmental impairment despite the widespread use of therapeutic hypothermia. Up to 80% of infants with HIE experience some degree of cardiovascular compromise, particularly involving right ventricular dysfunction, which has been associated with worse neurological outcomes and increased mortality.
Although vasoactive medications are frequently used in this population, there is no standardized or evidence-based approach regarding the optimal agent or timing of initiation. Dobutamine is a commonly used inotropic agent in neonates, with a favorable physiological profile that enhances cardiac contractility without significant increases in heart rate or systemic vascular resistance. Preliminary observational data suggest that dobutamine improves cardiac output in infants with HIE undergoing hypothermia.
Currently, dobutamine is typically initiated only after cardiovascular compromise becomes clinically apparent. A prophylactic approach, initiated early during therapeutic hypothermia, may help stabilize cardiac function, optimize systemic and cerebral perfusion, and potentially reduce secondary brain injury. Before a definitive efficacy trial can be conducted, it is necessary to establish the feasibility, safety, and protocol adherence of such an intervention. This pilot randomized controlled trial is designed to address that critical knowledge gap.
Objectives
Primary Objective
To determine the feasibility of initiating prophylactic dobutamine infusion within the first four hours of starting therapeutic hypothermia in newborns with HIE.
Secondary Objectives
To explore whether prophylactic dobutamine is associated with improved short-term clinical outcomes, including:
Presence and severity of brain injury on MRI Mortality Seizure activity (clinical or electrographic) Need for escalation of inotropic or vasoactive support Echocardiographic measures of cardiac function and pulmonary hemodynamics Time to normalization of lactate Duration of inhaled nitric oxide therapy, if required Urine output at 24, 48, and 72 hours Length of hospital stay until discharge or death Research Method / Procedures
This study is a single-center, double-blinded, randomized controlled feasibility trial conducted in a tertiary neonatal intensive care unit.
Eligible participants are newborns diagnosed with hypoxic-ischemic encephalopathy who are receiving therapeutic hypothermia. Infants will be excluded if they have congenital anomalies, contraindications to dobutamine, significant arrhythmias, or if they have already been started on inotropic support prior to randomization.
Participants will be randomized in a 1:1 ratio to either:
Intervention group: Prophylactic dobutamine infusion at 10 mcg/kg/min Control group: Placebo infusion (dextrose 5%) identical in appearance and administration Randomization will be computer-generated, with allocation concealment ensured through a secure REDCap system. The study will be double-blinded; parents, clinical staff, outcome assessors, and data analysts will remain unaware of group assignment until completion of the final analysis.
The assigned infusion (dobutamine or placebo) will be initiated within four hours of starting therapeutic hypothermia and continued until clinical improvement, escalation of cardiovascular support, or weaning at the discretion of the clinical team.
All participants will undergo standardized targeted neonatal echocardiography at two predefined time points during the first 48 hours. Clinical data will be collected throughout hospitalization, including laboratory results, imaging findings, medication use, adverse events, and outcomes.
Due to the emergency nature of HIE and the need for timely initiation of treatment, a deferred consent model will be used. Parents of surviving infants will be approached for written consent as soon as feasible after stabilization and prior to discharge. For infants who die before consent can be obtained, a waiver of consent will be requested for collection of minimal anonymized data.
Plan for Data Analysis
The primary analysis will focus on feasibility outcomes, including:
Proportion of eligible infants successfully receiving the intervention within four hours of initiating therapeutic hypothermia Protocol adherence rate The study will be considered feasible if more than 60% of eligible infants are recruited and more than 75% of randomized infants receive the assigned intervention without major protocol deviations.
Secondary clinical outcomes will be analyzed descriptively, as this pilot study is not powered to detect definitive efficacy differences. Continuous variables will be summarized using means, standard deviations, medians, and interquartile ranges as appropriate. Categorical variables will be reported as frequencies and percentages.
Comparisons between groups will be conducted using:
Student's t-test or Mann-Whitney U test for continuous variables Chi-square test for categorical variables All analyses will follow the intention-to-treat principle. Statistical significance will be defined as a two-sided p-value <0.05. Analyses will be performed using IBM SPSS and SAS statistical software after database lock and unblinding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dobutamine group | Experimental | Drug: Dobutamine, Diagnostic Test: TnECHOIf randomized to the prophylaxis/dobutamine arm, dobutamine will be administered at a dose of 10 mcg/kg/min via intravenous access within 4 hours of initiating TH. As a part of standard care for HIE, a central umbilical venous access is routinely acquired whenever possible. We will use the dobutamine concentration of 2000 mcg/ml. The infusion will be prepared in dextrose 5% solution in 50 mL bags. Dobutamine monograph is attached to the protocol as well (Appendix F). The infusion will be continued until either weaned by the clinical team, escalation of inotropic support, or improvement of clinical situation to allow weaning of dobutamine. |
| Control group | Placebo comparator | Diagnostic Test: TnECHOInfants randomized to the placebo arm will receive an inert preparation containing no active pharmacologic agent. The placebo will be identical in appearance, volume, and method of administration to the active intervention and will be administered according to the same dosing schedule and duration. We will use dextrose 5% (as placebo), which will be started within 4 hours of initiating TH. The infusion will be continued until either weaned by the clinical team, escalation of inotropic support, or improvement of clinical situation to allow weaning of dobutamine. |
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborns with hypoxemic ischemic encephalopathy (HIE) receiving therapeutic hypothermia (TH).
Key exclusion criteria (7 listed)
- Congenital abnormality
- known contraindication of dobutamine
- Newborns who are already started on inotropes at the time of randomization.
- Parental refusal to consent to participate
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 |
|---|---|---|
| DobutamineIf randomized to the prophylaxis/dobutamine arm, dobutamine will be administered at a dose of 10 mcg/kg/min via intravenous access within 4 hours of initiating TH. As a part of standard care for HIE, a central umbilical venous access is routinely acquired whenever possible. We will use the dobutamine concentration of 2000 mcg/ml. The infusion will be prepared in dextrose 5% solution in 50 mL bags. Dobutamine monograph is attached to the protocol as well (Appendix F). The infusion will be continued until either weaned by the clinical team, escalation of inotropic support, or improvement of clinical situation to allow weaning of dobutamine. | Drug | Dobutamine group |
| TnECHOIn both groups, 2 TnECHOs will be performed. TnECHO T1 will be performed within the 24 hours of randomization, and TnECHO T2 will be performed within 24-48 hours after TnECHO T1. All echocardiographic assessments are done by physicians trained in TnECHO or by pediatric cardiology team. Echocardiographic assessment will be performed as per the American Society or Echocardiography guidelines(63-66). Details of the standardised echo views and measurements are outlined in Appendix B. | Diagnostic test | Control group, Dobutamine group |
Primary outcome
Feasibility/Safety
Time frame: At 24 hours of age
Proportion of eligible infants receiving the intervention (or placebo) within 4 hours of initiating TH
12 secondary outcomes
Brain injury
Time frame: through study completion, an average of 1 month
Severity and type of brain injury
Time frame: through study completion, an average of 1 month
Mortality
Time frame: through study completion, an average of 1 month
Seizure activity
Time frame: through study completion, an average of 1 month
Need for escalation the inotropic support
Time frame: through study completion, an average of 1 month
TAPSE in mm
Time frame: through study completion, an average of 1 month
RV FAC in %
Time frame: through study completion, an average of 1 month
LV EF in %
Time frame: through study completion, an average of 1 month
Time to normalizing lactate in hours
Time frame: through study completion, an average of 1 month
Duration of inhaled nitric oxide in hours
Time frame: through study completion, an average of 1 month
Urine output in cc/k/hour
Time frame: through study completion, an average of 1 month
Length of hospital stay in days
Time frame: through study completion, an average of 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. IPD will not be shared to protect patient confidentiality. However, this could be re-considered if ethics approval is obtained from the requesting researcher and also the source ethics board.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dobutamine and TnECHO in people with Hypoxic-ischemic Encephalopathy (HIE), run by University of Alberta at 2 sites 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 1 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aimann Surak, MD FRCPC DRCPSC (780-735-4647, aimann@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility/Safety (time frame: At 24 hours of age). 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 20 Oct 2026.