Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04766541 |
| Other study ID # |
GOHIE |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 30, 2020 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
February 2021 |
| Source |
Hacettepe University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In this study, the correlation of cardiac marker values (Troponin I, CK, CK-MB) measured
before treatment with the long-term neurodevelopmental score of newborns diagnosed with
perinatal asphyxia and treated with therapeutic hypothermia with a diagnosis of hypoxic
ischemic encephalopathy (HIE) will be evaluated.
Physical examination, laboratory (especially cardiac markers), aEEG findings and diffusion
MRI findings of babies who have been hospitalized in the neonatal intensive care unit between
2015-2020 due to respiratory distress and who have undergone perinatal asphyxia but have
undergone therapeutic hypothermia treatment will be recorded from their files in the hospital
system. The neurological evaluations and neurodevelopmental scores of the babies in the
follow-up in the neonatal high risk follow-up clinic after discharge will be recorded from
their files.
Description:
With therapeutic hypothermia, it is aimed to reduce the temperature of brain structures and
basal ganglia to 32- 34 degrees for 72 hours. The mechanism of action of hypothermia can be
listed as decrease in cerebral metabolism, inhibition of edema, decrease in energy
metabolism, decrease in cytotoxic amino acid and nitric oxide accumulation, inhibition of
platelet activating factor and inflammatory cascade, suppression of free radical activity and
prevention of cell death.
Perinatal hypoxia not only affects brain tissue, but also all organs. Therefore, the baby's
respiratory system, blood gases, cardiac functions and liver functions are evaluated.
Electrolyte, blood sugar and blood pressure are closely monitored due to the possibility of
adrenal glands being affected. Since gastrointestinal injury is possible, nutrition is done
extremely slowly and carefully. The useful markers in determining the neurological prognosis
are the neurological findings of the patient as well as the defect in the aEEG monitoring.
Cardiac markers (CK, CK-MB, Troponin-I) have been shown to be a sensitive marker for asphyxia
in term infants. Any interruption in the placental blood supply can cause the fetus to
undergo hypoxic ischemia with the activation of the 'diving reflex' to protect the most vital
organs. However, because myocardial tissue has insufficient reserves to tolerate hypoxia,
myocardial injury may occur and an increase in serum troponin I, CK, CK-MB may occur. High
levels of cardiac markers are an indicator of ongoing myocardial damage during HIE.
Diffusion MR imaging performed after hypothermia tries to see the damaged areas in the brain.
Diffusion MRI and aEEG follow-up have been shown to be prognostic in the literature. Patients
with hypothermia are followed up in our neonatal outpatient clinic and monitored in terms of
growth and neurodevelopmental aspects.
In this study, the correlation of cardiac marker values (Troponin I, CK, CK-MB) measured
before treatment with the long-term neurodevelopmental score of newborns diagnosed with
perinatal asphyxia and treated with therapeutic hypothermia with a diagnosis of hypoxic
ischemic encephalopathy (HIE) will be evaluated.
Physical examination, laboratory (especially cardiac markers), aEEG findings and diffusion
MRI findings of babies who have been hospitalized in the neonatal intensive care unit between
2015-2020 due to respiratory distress and who have undergone perinatal asphyxia but have
undergone therapeutic hypothermia treatment will be recorded from their files in the hospital
system. The neurological evaluations and neurodevelopmental scores of the babies in the
follow-up in the neonatal high risk follow-up clinic after discharge will be recorded from
their files.
