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ANS Function in HIE Infants Treated With Therapeutic Hypothermia

NCT06730490 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2024-12-12

No results posted yet for this study

Summary

After birth, babies that have suffered from oxygen deprivation may develop hypoxic-ischemic encephalopathy (HIE). Moderate or severe HIE has been associated with death or disability. Therefore, these infants are treated with therapeutic hypothermia (TH), which should be initiated within the first six hours of life. This study aims to investigate the autonomic nervous system (ANS) function of these infants. Thus far, no systematic evaluation of ANS function has been performed, despite its potential in providing important information. Current methods include clinical assessment of pupils size and reactivity, and measurements of heart/respiratory rates. Thus, ANS function evaluation is rather limited and prone to significant inter-examiner variability. This study propose a more comprehensive analysis of ANS function by investigating heart rate variability (HRV) and whole body skin temperature distribution, skin perfusion, axillary and esophageal temperature complexity. The investigators hypothesize that HRV analysis and a more thorough evaluation of ANS function could provide additional information associated with important clinical outcomes, which could eventually be tested clinically.

Conditions

  • Hypoxic-Ischemic Encephalopathy

Sponsors & Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Guilherme M Sant'Anna, MD, PhD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility

Min Age
1 Hour
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06730490 on ClinicalTrials.gov