TRCMHIE: THE ROLE OF CARDIAC MARKERS IN HYPOXIC ISCHEMIC ENCEPHALOPATHY IN LONG-TERM NEURODEVELOPMENTAL FOLLOW UP

Sponsor

Hacettepe University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04766541

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxic-Ischemic Encephalopathy Newborn Morbidity	Other: no intervention

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

THE ROLE OF CARDIAC MARKERS IN HYPOXIC ISCHEMIC ENCEPHALOPATHY IN LONG-TERM NEURODEVELOPMENTAL FOLLOW UP

Actual Study Start Date :

Dec 30, 2020

Anticipated Primary Completion Date :

Mar 30, 2021

Anticipated Study Completion Date :

Jun 30, 2021

Outcome Measures

Primary Outcome Measures

Neurodevelopmental follow up Cardiac markers [12 months]
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.

Secondary Outcome Measures

Diffusion MRI and cardiac markers correlations [12 months]
Diffusion MR imaging and correlation with cardiac markers

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 28 Days

Sexes Eligible for Study:

All

Inclusion Criteria:

Babies who have been hospitalized in the Neonatal Intensive Care Unit of Hacettepe University İhsan Doğramacı Children's Hospital, have received therapeutic hypothermia treatment for perinatal asphyxia and are discharged and have neurodevelopmental assessments during their follow-up will be taken.

Exclusion Criteria:

Babies with chromosomal abnormalities Major congenital anomaly (congenital heart disease, lung anomaly, congenital diaphragmatic hernia, spina bifida etc.) Babies with inherited metabolic diseases • Babies with congenital muscle disease-hypotonicity