This research study is led by Brian Kalish, MD, a neonatologist and Director of the Program in Neonatal Neuroprotection and Neuroplasticity, and John Kheir, MD, a Senior Staff Physician in the Cardiac Intensive Care Unit and the Director of the Heart Center’s Translational Research Lab.
About HIE
Hypoxic-ischemic encephalopathy is an unexpected and rare event in which the baby does not receive enough blood flow and oxygen around the time of birth. This can result from a variety of factors, including placental abruption, uterine rupture, umbilical cord compression, among others. This is a true medical emergency, as it can lead to injury to many organs in the body, including the brain, kidneys, heart, liver, and lungs. The standard treatment for hypoxic-ischemic encephalopathy includes “cooling” babies down for several days after birth to protect the brain – a process called therapeutic hypothermia. While this therapy is helpful to improve survival and reduce brain injury, nearly half of babies still die or have long term neurodevelopmental delays.
A research study is taking place in the neonatal intensive care unit (NICU) at Boston Children’s Hospital and other participating sites to examine the use of small concentrations of hydrogen gas as a way to protect the brain, kidneys, and other organs from the injury that occur in babies with hypoxic-ischemic encephalopathy. Animal studies have shown that hydrogen significantly decreases injury to the brain and kidneys in this setting. A research study at Boston Children’s Hospital also showed that breathing this dose of hydrogen gas was well tolerated in healthy adults.
If a baby with hypoxic-ischemic encephalopathy is admitted to the NICU, he/she may be enrolled in the Hydrogen In neonatal Encephalopathy (HIE) trial. Patients who are enrolled in the research study will be randomly assigned to investigational treatment with hydrogen in addition to all standard of care treatments or to standard of care treatments without hydrogen. 2 out of 3 patients will be treated with hydrogen, and 1/3 patients will not receive standard treatment with no hydrogen. If enrolled, your child's safety will continue to be top priority, and he/she will receive all treatments he/she would otherwise get.
Because hypoxic-ischemic encephalopathy is a life-threatening emergency, and because the hydrogen must be used immediately, there may not be time to get informed consent from parents. Whenever possible, research study personnel will try to obtain your consent, or at least provide you an opportunity to object before the drug is started. In every case, after your child is enrolled in the research study, study personnel will promptly discuss the research study with you in further detail, and you can be removed from the research trial anytime at your request. We are available at 617-355-1651 or hydrogenHIEstudy@childrens.harvard.edu to answer any questions. You can learn more by visiting the study details page or by visiting clinicaltrials.gov.
If you do not wish your child to participate, you may opt out at any time before the medication is given, including now by filling out this brief form.