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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypoxic-Ischemic Encephalopathy; Newborn Morbidity
• Intervention / Treatment: 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.

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06230
    • Umit Ayse Tandircioglu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Newborns who were born with hypoxic ischemic encephalopathy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurodevelopmental follow up Cardiac markers	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diffusion MRI and cardiac markers correlations	Diffusion MR imaging and correlation with cardiac markers	12 months

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2020
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: February 20, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 20, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: newborn; hypoxic ischemic encephalopathy; bayley score; neurodevelopmental follow up
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Hypoxia, Brain; Brain Ischemia; Ischemia; Brain Diseases; Hypoxia; Hypoxia-Ischemia, Brain
• Other Study ID Numbers: GOHIE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: 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 2018-2020 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No