Was your newborn injured during therapeutic hypothermia or another HIE treatment?
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A baby’s first breath is a beautiful thing. Unfortunately, not all births go smoothly. And what happens in the delivery room or the neonatal intensive care unit (NICU) can impact a newborn and their parents for the rest of their lives.
When a baby is deprived of oxygen during labor and delivery, they are at risk of suffering permanent brain damage due to a condition known as “asphyxia” or “hypoxic-ischemic encephalopathy” (HIE). If left untreated, HIE can result in permanent brain damage and cell death, resulting in serious conditions such as cerebral palsy, brachial plexus injuries, nerve damage, seizure disorders, intellectual disabilities, development delays, motor disorders, hearing and vision loss.
Hypothermia therapy can effectively help minimize or freeze the rate of cell death in a newborn’s brain and prevent long-term brain damage; however, the window of time for this treatment is small. If doctors and medical teams fail to recognize the signs of HIE or they begin brain cooling therapy too late, then the damage may already be done.
When a serious birth injury happens because a doctor failed to uphold a certain standard of care—either by failing to diagnose HIE in a timely manner or not delivering the appropriate treatment soon enough—our birth injury attorneys help families hold these medical professionals responsible for their negligence.
Have questions about a birth injury?
Verdicts & Settlements Financial security for Your Child
Birth injury cases are like babies—every one is unique and special. Although these past success stories are no guarantee of success in your case, they can provide you examples of what we’ve been able to accomplish in similar cases. Contact us to determine the value of your potential claim.
HIE Malpractice Lawsuit
The child’s HIE and CP were caused by hypoxia and ischemia when the umbilical cord wrapped around the child’s neck, preventing the child from getting enough oxygen. The medical providers did not identify the warning signs and did not order a timely c-section. The delay caused severe and permanent injuries.
Cerebral Palsy Malpractice Lawsuit
The child suffered HIE and CP injuries when the medical professionals failed to timely order and perform a c-section in response to fetal distress warnings. A contingent (%) fee charged on the successful recovery resulted in a fee of $3,080,000 and litigation expenses and attorney’s fees which were reimbursed by the client out of the gross settlement amount.
Cerebral Palsy Malpractice Lawsuit
The child suffered HIE and CP as a result of uterine rupture, placental abruption, and a delay in performing an emergency c-section. A contingent (%) fee charged on the successful recovery resulted in a fee of $1,441,584 and litigation expenses and attorney’s fees which were reimbursed by the client out of the gross settlement amount.
FAQ Brain cooling therapy for newborns
When should my baby receive hypothermic brain cooling treatment?
Hypothermia therapy should be started as soon as possible after the hypoxic-ischemic injury. Current guidelines recommend that it begins within 6 hours of birth, though some research suggests that hypothermic therapy may be effective on newborns up to 24 hours old.
While the exact criteria for when a newborn is given brain cooling treatment can vary from hospital to hospital, the Neonatal Encephalopathy Task Force (a division of the Academic Medical Center Patient Safety Organization, or AMC PSO) has set the following general recommendations.
Eligibility Criteria I
If all 3 of these criteria are met, then therapeutic hypothermia should be given:
- The baby was born after 34 weeks of gestation (pregnancy) and is less than 6 hours old
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Any 1 of the following conditions are present:
- Sentinel event prior to delivery, such as uterine rupture, profound fetal bradycardia or cord prolapse
- Low Apgar scores (under 5 at 10 minutes of life)
- Prolonged resuscitation at birth (chest compressions, intubation and/or mask ventilation at 10 minutes)
- Severe acidosis (pH less than 7.0 from cord or neonate blood gas within 60 minutes of birth)
- Abnormal base excess less than or equal to 16 mEq/L from cord gas or neonate blood gas within 60 minutes of birth
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AND 1 of the following is true:
- There is a clinical event indicating a neonatal seizure
- There is evidence of neonatal encephalopathy during a clinical exam
Eligibility Criteria II
The AMC PSO advises doctors to consider hypothermia therapy when the following 3 criteria are met:
- The baby was born after 34 weeks of pregnancy and is no more than 12 hours old
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Any 1 of the following conditions are present:
- Sentinel event prior to delivery, such as uterine rupture, profound fetal bradycardia or cord prolapse
- Low Apgar scores (under 5 at 10 minutes of life)
- Prolonged resuscitation at birth (chest compressions, intubation and/or mask ventilation at 10 minutes)
- Acidosis (pH less than 7.1 from cord or neonate blood gas within 60 minutes of birth)
- Abnormal base excess less than or equal to 10 mEq/L from cord gas or neonate blood gas within 60 minutes of birth
- Postnatal collapse resulting in hypoxic-ischemic injury (i.e., near-SIDS type event)
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AND 1 of the following is true:
- There is a clinical event indicating a neonatal seizure
- There is evidence of neonatal encephalopathy during a clinical exam
The sooner this treatment begins, the better the odds that the newborn’s HIE-induced brain injuries will be reduced and a permanent disability can be avoided. Failing to provide hypothermic brain cooling when it’s needed may be considered medical malpractice, in which case a parent can pursue legal compensation.
When should a newborn NOT be given hypothermic therapy?
According to the AMC PSO, babies born preterm under 34 weeks into the pregnancy should absolutely not be given hypothermia treatment. In addition, doctors must take extra care when prescribing this treatment to newborns who:
- Weigh less than 1,750 grams (3.8 pounds)
- Have congenital abnormalities, genetic syndromes or metabolic disorders
- Have overwhelming septicemia
- Suffered major intracranial hemorrhage
- May have a blood clotting disorder
If a newborn is given therapeutic hypothermia treatment when they shouldn’t have (outside of the recommended criteria), then they can suffer additional injuries and the doctor may be liable for medical malpractice.
How does hypothermic brain cooling work?
Many parents wonder how the cooling process works and how therapeutic hypothermia halts the spread and severity of brain damage.
There are 2 different approaches to therapeutic hypothermia:
- Passive cooling techniques involve removing external heat sources from the newborn, such as blankets and heating lamps. This method is commonly used by remote hospitals and facilities with limited infrastructure that may be unable to transport newborns to a hypothermia center for active cooling within 6 hours.
- Active cooling is the preferred method. One study found that “the use of active cooling during neonatal transfer achieves target temperature in a shorter period and maintains better temperature stability.”
While the newborn cooling protocol and processes can vary depending on the hospital, it typically involves placing the baby on a waterproof blanket or putting a cooling cap on their head that contains cool circulating water until the baby’s body temperature is reduced to as low as 91.4 degrees Fahrenheit—below homeostasis—for around 72 hours.
This reduced body temperature helps slow the newborn’s metabolic rate, which allows their cells to heal and prevents the further spread of brain damage.
After the 72-hour treatment, the baby’s core body temperature must be returned to homeostasis (36.5 degrees Celsius, or 97.7 degrees Fahrenheit) gradually and carefully in order to avoid a reperfusion injury, which is when blood flow is restored too quickly to injured parts of the brain and brain damage is worsened.
During rewarming, there is a greater risk of seizure, so doctors should closely monitor the newborn—possibly using an EEG.
Does cooling help HIE, and is it dangerous?
Numerous studies have shown that hypothermia therapy can benefit newborns suffering from lack of oxygen at birth.
A 2005 study supported by the National Institutes of Health and published in the New England Journal of Medicine found that a cooling treatment given to newborns with birth asphyxia reduced the risk of death and disability by ages 18 to 22 months compared to routine care. Researchers discovered that newborns in the hypothermia group had a significantly lower mortality rate (28%) compared to the usual care group (44%).
In a subsequent study, researchers found that newborns with perinatal asphyxial encephalopathy who received hypothermic therapy showed improved neurocognitive outcomes in middle childhood—such as significant reductions in the risk of cerebral palsy and moderate or severe disability, as well as significantly better motor-function scores.
When administered correctly, researchers have found that there are relatively few risks associated with infant cooling therapy—and that the benefits generally outweigh the potential risks. The most common side effect is sinus bradycardia, or a slowed heartbeat, which is not considered to be life-threatening and can possibly be treated.
There are some risks involved in cooling therapy–primarily, medical professionals will watch for a sinus bradycardia, which means a slowed heart rate. A slowed heart rate is not necessarily dangerous, but should always be watched carefully. Usually the risks of cooling therapy are minimal in comparison to the risks of not using cooling therapy.
How can hypothermic brain cooling treatment go wrong?
Even though neonatal cooling therapy is a widely proven and generally accepted treatment for newborns experiencing HIE, it’s important for medical providers to carefully follow strict procedures and steps to ensure the effectiveness of the therapy and avoid potential negative impacts. Failure to follow these procedures can negate the treatment and cause further injury.
Here are some common examples of how therapeutic hypothermia in babies can go wrong:
- A baby is given hypothermic therapy too late (after 6-24 hours of birth)
- Failure to transfer the infant to an appropriate facility with active hypothermia capabilities
- A baby’s core body temperature is rewarmed too quickly, resulting in a reperfusion injury
- A newborn who doesn’t meet the eligibility criteria (i.e. is pre-term, has an APGAR score above 5, etc.) is given cooling therapy
- Cooling measures are not reduced or stopped when the baby’s rectal temperature falls below 95 degrees Fahrenheit
- The rectal thermometer isn’t properly inserted, thus resulting in incorrect readings of the baby’s temperature
- A baby exhibiting signs of stress is not given sedation, since stress has been shown to negate the effects of hypothermia therapy
- Sodium and chloride levels are not monitored and fall below normal levels
- The medical team fails to maintain normal glucose and electrolyte levels
- Oxygen saturation levels aren’t properly monitored, as cooled infants are at risk of persistent pulmonary hypertension
- Doctor fails to provide respiratory and cardiovascular support as needed
- Insufficient testing for and treating of infections
Many of the causes of HIE are entirely preventable with careful monitoring and quick treatment. It’s a sad reality that medical mistakes and doctor negligence are common causes of HIE.
How much is a baby’s body temperature cooled?
Typically medical professionals will cool the body to 33C (91.4F) give or take .5 degrees.
When is cooling therapy effective?
Studies indicate that cooling therapy is most effective when used within less than 6 hours after a hypoxic-ischemic injury. In general, treatment is more effective if it is applied closer to the injury than not.
UPDATE: a new study in 2017 suggests that cooling therapy may be helpful within as long as 24 hours after the injury. While the study is inconclusive, the results suggest that further study should be undertaken.
How long does cooling therapy take?
How long the therapy takes depends on the circumstances of the injury. In general, the more severe the injury, the longer the cooling therapy will be applied. It is not uncommon for medical professionals to keep an infant in cooling therapy for a period of up to two or three days.
What kind of injuries can cooling therapy help?
Cooling therapy is designed to prevent or minimize the effects of brain damage. Brain injuries can result in a number of different conditions, including:
- Cerebral Palsy
- Developmental Impairments
- Intellectual Disabilities
- Learning Disabilities
- Sensory Impairments
- Seizures
What facilities have cooling therapy?
While equipment may vary from facility to facility, infants are typically sent to a Neonatal Intensive Care Unit (NICU) for cooling therapy.
How effective is cooling therapy?
A study in a 2012 edition of the New England Journal of Medicine found that the mortality rate was reduced to 28% compared to 44% without cooling therapy. The study also found that the combined chance of death and severe disability was reduced to 41% as opposed to 60% without cooling therapy. Since that study, cooling therapy has widely been embraced as a go-to treatment for brain injuries related to lack of oxygen during birth and delivery.
What comes next after cooling therapy?
As cooling therapy ends, the baby will slowly be re-warmed back to normal body temperatures. If the baby is warmed too quickly, the surge of additional blood flow can cause what is called a “reperfusion injury.” The treatment plan following cooling therapy will vary case by case, but at a minimum, the medical professionals will probably wish to observe and monitor the baby to watch for further signs of injury.
Sources
Shankaran, S., Pappas, A., McDonald, S., Vohr, B., Hintz, S., & Yolton, K. et al. (2012). Childhood Outcomes after Hypothermia for Neonatal Encephalopathy. New England Journal Of Medicine, 366(22), 2085-2092. doi:10.1056/nejmoa1112066
G, G. (2020). Brain cooling therapy. – PubMed – NCBI . Ncbi.nlm.nih.gov. Retrieved 24 January 2020, from https://www.ncbi.nlm.nih.gov/pubmed/21089736
Laptook, A. R., Shankaran, S., Tyson, J. E., Munoz, B., Bell, E. F., Goldberg, R. N., … & Das, A. (2017). Effect of therapeutic hypothermia initiated after 6 hours of age on death or disability among newborns with hypoxic-ischemic encephalopathy: a randomized clinical trial. Jama, 318(16), 1550-1560.
Talk to an HIE attorney about your legal rights
Hypothermic brain cooling is a promising treatment option for newborns suffering from moderate to severe HIE. However, it’s vital that doctors, physicians, nurses and other medical staff strictly adhere to the guidelines and recommendations set by experts as the standard of care. Failing to administer cooling therapy in a timely manner or failing to inform parents about this treatment option, may constitute medical malpractice.
Laura Brown is a nationally respected and recognized birth injury lawyer who has devoted her career to representing injured babies and their families. She founded the Brown Trial Firm, a Texas-based law firm, to exclusively serve clients in Texas, Oklahoma and across the country. She has obtained many multi-million dollar settlements as a result of birth injury lawsuits and medical malpractice lawsuits.
