Hypoxic-Ischemic EncephalopathyNCT06730490
ANS Function in HIE Infants Treated With Therapeutic Hypothermia
An observational study of Hypoxic-Ischemic Encephalopathy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 72 hours
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy
- How many people
- 63 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 72 hours
- All sexes
- No healthy volunteers
- Child
Study population: Newborns admitted to the Montreal Children's Hospital neonatal intensive care unit (NICU) with mild, moderate or severe hypoxic-ischemic encephalopathy (HIE) and treated with therapeutic hypothermia (TH).
Who may be able to join
- Patients with Moderate or Severe HIE: 3 or more categories of the modified Sarnat Score in stage 2 or 3 (qualify for therapeutic hypothermia).
- Patients that are initiated on therapeutic hypothermia.
- Patients with Mild HIE, not treated with TH (control)
Who cannot join
- -No encephalopathy, defined normal neurological exam.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autonomic Nervous System Function in Hypoxic-Ischemic Infants Treated With Therapeutic Hypothermia
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.
Read the detailed description
- Problem and Hypothesis: Globally, an estimated 1.8 to 7.7 infants per 1000 live term births suffer from perinatal asphyxia or oxygen deprivation. This remains an important cause of HIE. Seven randomized control trials have demonstrated that therapeutic hypothermia (TH) is a safe and effective therapy for infants with moderate and severe HIE if initiated within the first 6 h of life. TH increases the chances of survival without increasing the rates of neurodevelopmental disability. Investigations of these infants have focused mainly on daily neurological exams (modified Sarnat Score), electrical activity of the brain (amplitude integrated electroencephalography or aEEG and EEG), and brain imaging. No systematic evaluation of the 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 and are therefore limited and prone to significant inter-examiner variability. As such, in this study the investigators are planning to performing a more comprehensive analysis of ANS function under the hypothesis that in HIE infants treated with TH; a more thorough analysis of ANS function will provide additional information that can be associated with clinical outcomes.
- Objectives: The objectives of the study are to measure and analyze the following variables of ANS function during TH and compare results between infants with and without poor outcomes:
- Heart rate variability (primary outcome)
- Skin temperature distribution and skin perfusion (secondary outcome)
- Axillary temperature complexity (secondary outcome)
- Esophageal temperature complexity (secondary outcome) A poor outcome will be defined as the composite of death, abnormal neurological exam at the end of the TH period or at discharge or transfer (whichever comes first), and abnormal brain MRI at day of life 10.
- Methods and Analysis: For each newborn diagnosed with moderate or severe HIE and treated with TH, the investigators will collect demographics data using a pre-defined data collection form. Moreover, images of whole body temperature, recordings of axillary and esophageal temperature, and electrocardiogram (ECG), will be performed according to the following steps for days 1, 2 and 3 of TH:
- Whole body infrared picture: infrared images (IR) of the whole infant will be obtained by using the E60bx camera (FLIR Systems, Inc. USA, Boston, MA). Whole body skin temperature will be analyzed by mapping temperature at the following areas: head, trunk, abdomen, upper and lower limbs, and upper and lower extremities. Mean ± SD and range values will be calculated for each area using the specific IR software. This will allow evaluation of skin temperature distribution for each patient for the specified study periods.
- Skin perfusion: will be recorded by using the skin blood FlowMeter (ADInstruments, Bella Vista, Australia). A small surface probe will be placed at the abdomen just above the liver area using a self-adhesive ring.
- Axillary temperature (Ta) and heart rate (HR): Ta will be recorded continuously for 1 h period using a probe placed at the R axilla and connected to the PowerLab data acquisition system®. The complexity of the temperature curve will be quantified using the approximate entropy (ApEn). HR will be measured by applying 3 ECG leads connected to a BioAmp and the PowerLab data acquisition system®. Heart rate variability (HRV) will be calculated using the time domain and frequency domain analysis, from 5 minutes segments of ECG and with the HRV module of the Labchart software®.
- Esophageal temperature (Tes): will be collected every 5 minutes during the 1 h study period from the Blanketrol system device. Mean ± SD and the coefficient of variation of Tes values will be calculated.
- Feasibility: Systematic evaluations of ANS function using the proposed study design and technologies have never been performed. Therefore, we will use a convenient sample size of 30 patients. In our NICU, approximately 40 infants with moderate and severe HIE are admitted and treated with TH every year. Thus, accounting for a 50-60% of loss to enroll due to refusal to consent, competing studies, unavailability of the research team, and patient instability, we estimate that we'll need a time frame between 24-30 months to achieve the calculated sample size of 30 patients. The same measurements will be performed in 15 patients with mild HIE (not cooled) as a control group.
- Clinical Significance:
If any measurements of ANS function prove to be robust, they could have important implications for clinical practice. One aspect for future research is whether there is a correlation between ANS function and severity of disability or death.
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Keywords
- Autonomic Nervous System, Therapeutic Hypothermia, Hypoxic-Ischemic Encephalopathy
- Medical subject headings
- Hypoxia-Ischemia, Brain
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability (HRV)
Heart rate variability (HRV) will be calculated using the time domain and frequency domain analysis and with the HRV module of the Labchart software®.
Measured: 6 months
Secondary outcomes (4)
Whole body skin temperature (WBST)
Whole body skin temperature (WBST): by using infrared (IR) images to map body temperature at the following areas: head, trunk, abdomen, upper and lower limbs, and upper and lower extremities. Mean ± SD and range values will be calculated for each area using the specific IR software.
Measured: 6 months
Skin perfusion
Skin perfusion will be recorded by using the skin blood FlowMeter (ADInstruments, Bella Vista, Australia). A small surface probe will be placed at the abdomen just above the liver area using a self-adhesive ring.
Measured: 6 months
Axillary temperature (Ta)
Axillary temperature (Ta) will be recorded continuously for 1 h period using a probe placed at the R axilla and connected to the PowerLab data acquisition system®.
Measured: 6 months
Esophageal temperature (Tes)
Esophageal temperature (Tes): will be collected every 5 minutes during the 1 h study period from the Blanketrol system device. Mean ± SD and the coefficient of variation of Tes values will be calculated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study startFeb 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Sant'Anna, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Guilherme M Sant'Anna, MD, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730490
- Sponsor's protocol ID
- ANS STUDY 01
- Status last verified
- Dec 2024
- First submitted
- 21 Aug 2018
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lawn J, Shibuya K, Stein C. No cry at birth: global estimates of intrapartum stillbirths and intrapartum-related neonatal deaths. Bull World Health Organ. 2005 Jun;83(6):409-17. Epub 2005 Jun 17.
PubMed 15976891Shankaran S, Laptook AR, Ehrenkranz RA, Tyson JE, McDonald SA, Donovan EF, Fanaroff AA, Poole WK, Wright LL, Higgins RD, Finer NN, Carlo WA, Duara S, Oh W, Cotten CM, Stevenson DK, Stoll BJ, Lemons JA, Guillet R, Jobe AH; National Institute of Child Health and Human Development Neonatal Research Network. Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med. 2005 Oct 13;353(15):1574-84. doi: 10.1056/NEJMcps050929.
PubMed 16221780Gluckman PD, Wyatt JS, Azzopardi D, Ballard R, Edwards AD, Ferriero DM, Polin RA, Robertson CM, Thoresen M, Whitelaw A, Gunn AJ. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial. Lancet. 2005 Feb 19-25;365(9460):663-70. doi: 10.1016/S0140-6736(05)17946-X.
PubMed 15721471Zhou WH, Cheng GQ, Shao XM, Liu XZ, Shan RB, Zhuang DY, Zhou CL, Du LZ, Cao Y, Yang Q, Wang LS; China Study Group. Selective head cooling with mild systemic hypothermia after neonatal hypoxic-ischemic encephalopathy: a multicenter randomized controlled trial in China. J Pediatr. 2010 Sep;157(3):367-72, 372.e1-3. doi: 10.1016/j.jpeds.2010.03.030. Epub 2010 May 20.
PubMed 20488453Simbruner G, Mittal RA, Rohlmann F, Muche R; neo.nEURO.network Trial Participants. Systemic hypothermia after neonatal encephalopathy: outcomes of neo.nEURO.network RCT. Pediatrics. 2010 Oct;126(4):e771-8. doi: 10.1542/peds.2009-2441. Epub 2010 Sep 20.
PubMed 20855387Jacobs SE, Morley CJ, Inder TE, Stewart MJ, Smith KR, McNamara PJ, Wright IM, Kirpalani HM, Darlow BA, Doyle LW; Infant Cooling Evaluation Collaboration. Whole-body hypothermia for term and near-term newborns with hypoxic-ischemic encephalopathy: a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Aug;165(8):692-700. doi: 10.1001/archpediatrics.2011.43. Epub 2011 Apr 4.
PubMed 21464374Azzopardi DV, Strohm B, Edwards AD, Dyet L, Halliday HL, Juszczak E, Kapellou O, Levene M, Marlow N, Porter E, Thoresen M, Whitelaw A, Brocklehurst P; TOBY Study Group. Moderate hypothermia to treat perinatal asphyxial encephalopathy. N Engl J Med. 2009 Oct 1;361(14):1349-58. doi: 10.1056/NEJMoa0900854.
PubMed 19797281Laptook A, Tyson J, Shankaran S, McDonald S, Ehrenkranz R, Fanaroff A, Donovan E, Goldberg R, O'Shea TM, Higgins RD, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Elevated temperature after hypoxic-ischemic encephalopathy: risk factor for adverse outcomes. Pediatrics. 2008 Sep;122(3):491-9. doi: 10.1542/peds.2007-1673.
PubMed 18762517Varela M, Churruca J, Gonzalez A, Martin A, Ode J, Galdos P. Temperature curve complexity predicts survival in critically ill patients. Am J Respir Crit Care Med. 2006 Aug 1;174(3):290-8. doi: 10.1164/rccm.200601-058OC. Epub 2006 May 11.
PubMed 16690981Varela M, Calvo M, Chana M, Gomez-Mestre I, Asensio R, Galdos P. Clinical implications of temperature curve complexity in critically ill patients. Crit Care Med. 2005 Dec;33(12):2764-71. doi: 10.1097/01.ccm.0000190157.64486.03.
PubMed 16352958Varela M, Jimenez L, Farina R. Complexity analysis of the temperature curve: new information from body temperature. Eur J Appl Physiol. 2003 May;89(3-4):230-7. doi: 10.1007/s00421-002-0790-2. Epub 2003 Mar 4.
PubMed 12736830Glass L. Synchronization and rhythmic processes in physiology. Nature. 2001 Mar 8;410(6825):277-84. doi: 10.1038/35065745.
PubMed 11258383Shankaran S, Laptook AR, Tyson JE, Ehrenkranz RA, Bann CM, Das A, Higgins RD, Bara R, Pappas A, McDonald SA, Goldberg RN, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Evolution of encephalopathy during whole body hypothermia for neonatal hypoxic-ischemic encephalopathy. J Pediatr. 2012 Apr;160(4):567-572.e3. doi: 10.1016/j.jpeds.2011.09.018. Epub 2011 Nov 1.
PubMed 22050871Rutherford M, Ramenghi LA, Edwards AD, Brocklehurst P, Halliday H, Levene M, Strohm B, Thoresen M, Whitelaw A, Azzopardi D. Assessment of brain tissue injury after moderate hypothermia in neonates with hypoxic-ischaemic encephalopathy: a nested substudy of a randomised controlled trial. Lancet Neurol. 2010 Jan;9(1):39-45. doi: 10.1016/S1474-4422(09)70295-9. Epub 2009 Nov 5.
PubMed 19896902
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Nervous System Function in Hypoxic-Ischemic Infants Treated With Therapeutic Hypothermia
- ClinicalTrials.gov ID
- NCT06730490
- Acronym / sponsor ID
- ANS STUDY 01
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Keywords
- Autonomic Nervous System, Therapeutic Hypothermia, Hypoxic-Ischemic Encephalopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Problem and Hypothesis: Globally, an estimated 1.8 to 7.7 infants per 1000 live term births suffer from perinatal asphyxia or oxygen deprivation. This remains an important cause of HIE. Seven randomized control trials have demonstrated that therapeutic hypothermia (TH) is a safe and effective therapy for infants with moderate and severe HIE if initiated within the first 6 h of life. TH increases the chances of survival without increasing the rates of neurodevelopmental disability. Investigations of these infants have focused mainly on daily neurological exams (modified Sarnat Score), electrical activity of the brain (amplitude integrated electroencephalography or aEEG and EEG), and brain imaging. No systematic evaluation of the 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 and are therefore limited and prone to significant inter-examiner variability. As such, in this study the investigators are planning to performing a more comprehensive analysis of ANS function under the hypothesis that in HIE infants treated with TH; a more thorough analysis of ANS function will provide additional information that can be associated with clinical outcomes.
- Objectives: The objectives of the study are to measure and analyze the following variables of ANS function during TH and compare results between infants with and without poor outcomes:
- Heart rate variability (primary outcome)
- Skin temperature distribution and skin perfusion (secondary outcome)
- Axillary temperature complexity (secondary outcome)
- Esophageal temperature complexity (secondary outcome) A poor outcome will be defined as the composite of death, abnormal neurological exam at the end of the TH period or at discharge or transfer (whichever comes first), and abnormal brain MRI at day of life 10.
- Methods and Analysis: For each newborn diagnosed with moderate or severe HIE and treated with TH, the investigators will collect demographics data using a pre-defined data collection form. Moreover, images of whole body temperature, recordings of axillary and esophageal temperature, and electrocardiogram (ECG), will be performed according to the following steps for days 1, 2 and 3 of TH:
- Whole body infrared picture: infrared images (IR) of the whole infant will be obtained by using the E60bx camera (FLIR Systems, Inc. USA, Boston, MA). Whole body skin temperature will be analyzed by mapping temperature at the following areas: head, trunk, abdomen, upper and lower limbs, and upper and lower extremities. Mean ± SD and range values will be calculated for each area using the specific IR software. This will allow evaluation of skin temperature distribution for each patient for the specified study periods.
- Skin perfusion: will be recorded by using the skin blood FlowMeter (ADInstruments, Bella Vista, Australia). A small surface probe will be placed at the abdomen just above the liver area using a self-adhesive ring.
- Axillary temperature (Ta) and heart rate (HR): Ta will be recorded continuously for 1 h period using a probe placed at the R axilla and connected to the PowerLab data acquisition system®. The complexity of the temperature curve will be quantified using the approximate entropy (ApEn). HR will be measured by applying 3 ECG leads connected to a BioAmp and the PowerLab data acquisition system®. Heart rate variability (HRV) will be calculated using the time domain and frequency domain analysis, from 5 minutes segments of ECG and with the HRV module of the Labchart software®.
- Esophageal temperature (Tes): will be collected every 5 minutes during the 1 h study period from the Blanketrol system device. Mean ± SD and the coefficient of variation of Tes values will be calculated.
- Feasibility: Systematic evaluations of ANS function using the proposed study design and technologies have never been performed. Therefore, we will use a convenient sample size of 30 patients. In our NICU, approximately 40 infants with moderate and severe HIE are admitted and treated with TH every year. Thus, accounting for a 50-60% of loss to enroll due to refusal to consent, competing studies, unavailability of the research team, and patient instability, we estimate that we'll need a time frame between 24-30 months to achieve the calculated sample size of 30 patients. The same measurements will be performed in 15 patients with mild HIE (not cooled) as a control group.
- Clinical Significance:
If any measurements of ANS function prove to be robust, they could have important implications for clinical practice. One aspect for future research is whether there is a correlation between ANS function and severity of disability or death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns admitted to the Montreal Children's Hospital neonatal intensive care unit (NICU) with mild, moderate or severe hypoxic-ischemic encephalopathy (HIE) and treated with therapeutic hypothermia (TH).
Key inclusion criteria (3 listed)
- Patients with Moderate or Severe HIE: 3 or more categories of the modified Sarnat Score in stage 2 or 3 (qualify for therapeutic hypothermia).
- Patients that are initiated on therapeutic hypothermia.
- Patients with Mild HIE, not treated with TH (control)
Key exclusion criteria (1 listed)
- -No encephalopathy, defined normal neurological exam.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart rate variability (HRV)
Time frame: 6 months
Heart rate variability (HRV) will be calculated using the time domain and frequency domain analysis and with the HRV module of the Labchart software®.
4 secondary outcomes
Whole body skin temperature (WBST)
Time frame: 6 months
Skin perfusion
Time frame: 6 months
Axillary temperature (Ta)
Time frame: 6 months
Esophageal temperature (Tes)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 15976891Lawn J, Shibuya K, Stein C. No cry at birth: global estimates of intrapartum stillbirths and intrapartum-related neonatal deaths. Bull World Health Organ. 2005 Jun;83(6):409-17. Epub 2005 Jun 17.
- Background: PubMed 16221780Shankaran S, Laptook AR, Ehrenkranz RA, Tyson JE, McDonald SA, Donovan EF, Fanaroff AA, Poole WK, Wright LL, Higgins RD, Finer NN, Carlo WA, Duara S, Oh W, Cotten CM, Stevenson DK, Stoll BJ, Lemons JA, Guillet R, Jobe AH; National Institute of Child Health and Human Development Neonatal Research Network. Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med. 2005 Oct 13;353(15):1574-84. doi: 10.1056/NEJMcps050929.
- Background: PubMed 15721471Gluckman PD, Wyatt JS, Azzopardi D, Ballard R, Edwards AD, Ferriero DM, Polin RA, Robertson CM, Thoresen M, Whitelaw A, Gunn AJ. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial. Lancet. 2005 Feb 19-25;365(9460):663-70. doi: 10.1016/S0140-6736(05)17946-X.
- Background: PubMed 20488453Zhou WH, Cheng GQ, Shao XM, Liu XZ, Shan RB, Zhuang DY, Zhou CL, Du LZ, Cao Y, Yang Q, Wang LS; China Study Group. Selective head cooling with mild systemic hypothermia after neonatal hypoxic-ischemic encephalopathy: a multicenter randomized controlled trial in China. J Pediatr. 2010 Sep;157(3):367-72, 372.e1-3. doi: 10.1016/j.jpeds.2010.03.030. Epub 2010 May 20.
- Background: PubMed 20855387Simbruner G, Mittal RA, Rohlmann F, Muche R; neo.nEURO.network Trial Participants. Systemic hypothermia after neonatal encephalopathy: outcomes of neo.nEURO.network RCT. Pediatrics. 2010 Oct;126(4):e771-8. doi: 10.1542/peds.2009-2441. Epub 2010 Sep 20.
- Background: PubMed 21464374Jacobs SE, Morley CJ, Inder TE, Stewart MJ, Smith KR, McNamara PJ, Wright IM, Kirpalani HM, Darlow BA, Doyle LW; Infant Cooling Evaluation Collaboration. Whole-body hypothermia for term and near-term newborns with hypoxic-ischemic encephalopathy: a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Aug;165(8):692-700. doi: 10.1001/archpediatrics.2011.43. Epub 2011 Apr 4.
- Background: PubMed 19797281Azzopardi DV, Strohm B, Edwards AD, Dyet L, Halliday HL, Juszczak E, Kapellou O, Levene M, Marlow N, Porter E, Thoresen M, Whitelaw A, Brocklehurst P; TOBY Study Group. Moderate hypothermia to treat perinatal asphyxial encephalopathy. N Engl J Med. 2009 Oct 1;361(14):1349-58. doi: 10.1056/NEJMoa0900854.
- Background: PubMed 18762517Laptook A, Tyson J, Shankaran S, McDonald S, Ehrenkranz R, Fanaroff A, Donovan E, Goldberg R, O'Shea TM, Higgins RD, Poole WK; National Institute of Child Health and Human Development Neonatal Research Network. Elevated temperature after hypoxic-ischemic encephalopathy: risk factor for adverse outcomes. Pediatrics. 2008 Sep;122(3):491-9. doi: 10.1542/peds.2007-1673.
- Background: PubMed 16690981Varela M, Churruca J, Gonzalez A, Martin A, Ode J, Galdos P. Temperature curve complexity predicts survival in critically ill patients. Am J Respir Crit Care Med. 2006 Aug 1;174(3):290-8. doi: 10.1164/rccm.200601-058OC. Epub 2006 May 11.
- Background: PubMed 16352958Varela M, Calvo M, Chana M, Gomez-Mestre I, Asensio R, Galdos P. Clinical implications of temperature curve complexity in critically ill patients. Crit Care Med. 2005 Dec;33(12):2764-71. doi: 10.1097/01.ccm.0000190157.64486.03.
- Background: PubMed 12736830Varela M, Jimenez L, Farina R. Complexity analysis of the temperature curve: new information from body temperature. Eur J Appl Physiol. 2003 May;89(3-4):230-7. doi: 10.1007/s00421-002-0790-2. Epub 2003 Mar 4.
- Background: PubMed 11258383Glass L. Synchronization and rhythmic processes in physiology. Nature. 2001 Mar 8;410(6825):277-84. doi: 10.1038/35065745.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guilherme M Sant'Anna, MD, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic-Ischemic Encephalopathy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (HRV) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06730490, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.