The PROTECT-HIE Pilot Trial
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-1
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newborns with hypoxemic ischemic encephalopathy (HIE) receiving therapeutic hypothermia (TH).
Disqualifiers
Congenital abnormality
known contraindication of dobutamine
Left ventricular outflow tract dynamic obstruction
Hypersensitivity to dobutamine
Trial design
Design model
Parallel
Treatments tested in this trial
Dobutamine
DrugIf 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.
TnECHO
Diagnostic testIn 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Dobutamine groupExperimental treatment 2 interventions
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility/Safety
Proportion of eligible infants receiving the intervention (or placebo) within 4 hours of initiating TH
Time frame
At 24 hours of ageSecondary outcomes
1
Brain injury
Brain injury on MRI (normal/abnormal)
Time frame
through study completion, an average of 1 month2
Severity and type of brain injury
Severity and type of brain injury on head MRI \[as per reference # 72 in the uploaded protocol, Mohammad K, et al. Consensus Approach for Standardization of the Timin\]
Time frame
through study completion, an average of 1 month3
Mortality
Death (yes/no)
Time frame
through study completion, an average of 1 month4
Seizure activity
Presence of seizure activity either clinically or on EEG (yes/no)
Time frame
through study completion, an average of 1 monthSponsors and contacts
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Source ClinicalTrials.gov
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