NCT06730490

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2018

Completed
6.3 years until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

August 21, 2018

Last Update Submit

December 11, 2024

Conditions

Hypoxic-Ischemic Encephalopathy

Keywords

Autonomic Nervous SystemTherapeutic HypothermiaHypoxic-Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (1)

  • 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®.

    6 months

Secondary Outcomes (4)

  • Whole body skin temperature (WBST)

    6 months

  • Skin perfusion

    6 months

  • Axillary temperature (Ta)

    6 months

  • Esophageal temperature (Tes)

    6 months

Eligibility Criteria

Age1 Hour - 72 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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)

You may not qualify if:

  • No encephalopathy, defined normal neurological exam.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H4A3J1, Canada

Location

Related Publications (14)

  • 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.

    PMID: 15976891BACKGROUND

  • Shankaran 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.

    PMID: 16221780BACKGROUND

  • Gluckman 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.

    PMID: 15721471BACKGROUND

  • Zhou 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.

    PMID: 20488453BACKGROUND

  • Simbruner 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.

    PMID: 20855387BACKGROUND

  • Jacobs 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.

    PMID: 21464374BACKGROUND

  • Azzopardi 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.

    PMID: 19797281BACKGROUND

  • Laptook 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.

    PMID: 18762517BACKGROUND

  • Varela 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.

    PMID: 16690981BACKGROUND

  • Varela 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.

    PMID: 16352958BACKGROUND

  • Varela 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.

    PMID: 12736830BACKGROUND

  • Glass L. Synchronization and rhythmic processes in physiology. Nature. 2001 Mar 8;410(6825):277-84. doi: 10.1038/35065745.

    PMID: 11258383BACKGROUND

  • Shankaran 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.

    PMID: 22050871BACKGROUND

  • Rutherford 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.

    PMID: 19896902BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guilherme M Sant'Anna, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

August 21, 2018

First Posted

December 12, 2024

Study Start

February 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 12, 2024

Record last verified: 2024-12

Locations

CA(1)