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

NCT04766541 | Unknown

• 1 other identifier: GOHIE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic-Ischemic Encephalopathy; Newborn Morbidity

Keywords

newborn; hypoxic ischemic encephalopathy; bayley score; neurodevelopmental follow up

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diffusion MRI and cardiac markers correlations

  12 months

Interventions

no intervention OTHER

There is no intervention.

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns who were born with hypoxic ischemic encephalopathy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Umit Ayse Tandircioglu

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: February 23, 2021
• Study Start: December 30, 2020
• Primary Completion: March 30, 2021
• Study Completion: June 30, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

TU (1)