Neonatal EncephalopathyNCT05756296
The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era
An observational study of Neonatal Encephalopathy and Therapeutic Hypothermia, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial summary
The goal of this study is to characterize the ability and related brain profiles of children with Neonatal encephalopathy (NE) - Therapeutic hypothermia (TH) at 9 years old. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Neonatal Encephalopathy, Therapeutic Hypothermia, Brain Injuries
- What is being tested?
- Therapeutic hypothermia
- Type of treatment
- Surgery or procedure
- How many people
- 198 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Nov 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Existing clinical cohort of children born between 2014 and 2018, who received TH for NE treated at the two largest neonatal intensive care units and neonatal follow-up programs in Quebec (Canada), the Montreal Children's Hospital (MCH) of the McGill University Health Centre and the Centre Hospitalier Universitaire Ste-Justine (CHUSJ).
Who may be able to join
- born between 2014 and 2018
- received whole-body cooling to an esophageal temperature of 33.5°C initiated within the first 6 hours of life, continued for 72 hours, and then they were slowly rewarmed received TH for moderate or severe NE
Who cannot join
- Participants with a history of
- congenital infections
- genetic or metabolic disorders
- major brain malformations (e.g., lissencephaly) and
- any contraindication for MRI (e.g., metal implant, claustrophobia)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Centre Hospitalier Universitaire Ste-Justine (CHUSJ).
Montreal, Quebec, H3T 1C5
Marie Brossard-Racine, PhD, (514)934-1934 ext. 76295, marie.brossardracine@mcgill.ca
Marie Brossard-Racine, PhD
the Montreal Children's Hospital (MCH) of the McGill University Health Centre
Montreal, Quebec, H4A 3J1
Marie Brossard-Racine, PhD, (514)934-1934 ext. 76295, marie.brossardracine@mcgill.ca
Marie Brossard-Racine, PhD
About this study
Official title: The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era: Protocol for a Follow-up Cohort Study at 9 Years of Age
The goal of this study is to characterize the ability and related brain profiles of children with Neonatal encephalopathy (NE) - Therapeutic hypothermia (TH) at 9 years old. The main questions it aims to answer are:
- Compare executive function, attention, social cognition, behaviour, anxiety, self-esteem, and peer problems between children with NE-TH and matched peers without NE.
- Compare brain volumes, cortical and subcortical morphology, white matter microstructure, and myelination between children with NE-TH and matched peers without NE.
- Evaluate the associations of perinatal risk factors and structural brain integrity with neuropsychological deficits to inform about the potential aggravating and protective factors for neuropsychological functioning.
Participants will complete one study visit to perform standardized evaluations and a brain MRI. Parents of participants will be invited to complete a series of questionnaires during this study visit or at a moment of their choice virtually.
Read the detailed description
Rationale:
Therapeutic hypothermia (TH) became the standard of care treatment for neonates with moderate and severe neonatal encephalopathy (NE) in most industrialized countries about 10 years ago. Although TH is effective in reducing mortality and the incidence of severe developmental disabilities, various morbidities are still frequent in survivors. Moreover, because the focus of previous follow-up studies has been restricted to mortality rates and the most severe forms of morbidities, it is wrong to conclude that TH minimizes all developmental deficits. In fact, recent literature reports frequent cognitive and behavioural difficulties at school entry in children with NE-TH without severe disabilities. Although these difficulties can be less impressive than cerebral palsy and intellectual disability, their negative impacts on a child's self-determination and family well-being are not less important and their nature and extend need to be comprehensively assessed.
Aims and Hypotheses:
- To compare higher-order cognitive, socialization, and psycho-emotional abilities using comprehensive standardized assessments of outcomes between 9-year-old children with NE-TH and age- and sex-matched peers without NE. Hypothesis 1: Children with NE-TH will display lower IQ, executive functioning, attention, social cognition, and self-esteem, but more anxiety and behavioural and peer problems than age- and sex-matched peers without NE-TH.
- To compare structural brain integrity using quantitative MRI between 9-year-old children with NE-TH and age- and sex-matched peers without NE. Hypothesis 2: Children with NE-TH will present with smaller total and regional (basal ganglia, hippocampus, cerebellum) brain volumes, altered cortical and subcortical morphometry, and widespread white matter microstructural and myelination alterations when compared to age- and sex-matched peers without NE-TH.
- To evaluate the relationships between cognitive, psycho-emotional and motor skills at 9 years and (1) individual and perinatal risk factors and (2) structural brain integrity at 9 years.
Hypothesis 3: A combination of individual (e.g., socio-economic), perinatal factors (e.g., neonatal brain injury) and markers of aberrant brain integrity (e.g., volume, microstructure) will be associated with domain-specific deficits at 9 years in children with NE-TH.
Population:
Children born between 2014 and 2018, who received whole-body cooling to an esophageal temperature of 33.5°C initiated within the first 6 hours of life, continued for 72 hours, and then they were slowly rewarmed for moderate or severe NE at one of the two centers will be approached. Eligibility for TH at our institutions followed those established in previous TH trials. Participants with a history of (1) congenital infections, (2) genetic or metabolic disorders, or (3) major brain malformations (e.g., lissencephaly), as well as (4) any contraindication for MRI (e.g., metal implant, claustrophobia), are ineligible.
For each of two same-sex and same-age NE-TH participants, a matched control for age (+/- 6 months of mean age) and sex will be recruited. Participants born at term (gestational age ≥37 weeks), without neonatal complication, will be considered as ineligible controls. Inclusion criteria for the controls include the same were similar to the NE-TH group, and a previous history of neurodevelopmental delay or disorder, or a traumatic brain injury were the specific exclusion cirteria for the comparison group.
Assessment procedure:
For this study, enrollees will complete one study visit to perform standardized evaluations and a brain MRI. Children will have the opportunity to familiarize themselves with the MRI environment on a mock scanner before the MRI and to watch a movie or listen to the music of their choice during the acquisition. Parents will be invited to complete a series of questionnaires during their child's testing or at a moment of their choice via a provided secure link. The visit will start with the outcome evaluations that are the most cognitively demanding and breaks will be provided as necessary. Outcome evaluations will be conducted by trained research staff or trainees blinded to the details of the child's neonatal and developmental history, and group allocation (i.e., NE-TH vs. control) to the extent possible. The choice of outcome measures has been made based on their clinical significance, psychometric properties, and availability in both French and English, considering the bilingual context of Quebec, Canada.
- Being tested
- Therapeutic hypothermia
- Keywords
- Cerebral Palsy, Brain, Neonate, Developmental Delay, MRI, Child Development
- Medical subject headings
- Brain Injuries, Cerebral Palsy, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic hypothermiaProcedure or surgery
whole-body cooling to an esophageal temperature of 33.5°C initiated within the first 6 hours of life, continued for 72 hours, and then they were slowly rewarmed for moderate or severe NE
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Children aged 9 years old with NE-TH meeting study inclusion criteria. Receives: Procedure: Therapeutic hypothermia | |
| Control group | A comparison group of sex and age matched children with no NE-TH meeting similar study inclusion criteria to intervention group. Specific exclusion criteria for matched control group include a previous history of neurodevelopmental delay or disorder, or a traumatic brain injury, and born at term (gestational age ≥37 weeks), or born without neonatal complication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Higher order cognitive abilities
Estimated IQ (Wechsler Abbreviated Scale of Intelligence 2nd ed. [WASI-2]), inhibition (Stroop test), planning (Tower - Delis-Kaplan Executive Function System [D-KEFS] and Rey-Osterrieth Complex Figure), impulsivity (Conner Continuous Performance Test - 3rd Ed [CPT-3]), working memory (Digit span), and word retrieval (verbal fluency - D-KEFS). Specific attentional skills; immediate (Digit Span) and sustained attention (CPT-3). Visual memory (Rey-Osterrieth Complex Figure). To characterize the ability to understand that others have thoughts, ideas, and feelings, and how emotion relates to social context, as well as the ability to recognize affect (Theory of Mind and Affect Recognition subtests).
Measured: DAY 1
Psycho-emotional abilities
Self-esteem (Self-Concept Inventory from the Beck Youth Inventories-II), children's anxiety and emotional regulation (Spence Children's Anxiety Scale, the Multidimensional Anxiety Scale for Children, and the Difficulties in Emotion Regulation Scales). Predominance of profiles (e.g., predominantly affective, cognitive, or generalized) will be examined following an in-depth interpretation of the cognitive and psycho-emotional outcomes.
Measured: DAY 1
Motor skills
Motor skills will be evaluated using the Movement Assessment Battery for Children-2nd Ed.in children without CP. In children with CP, motor skills will be evaluated with the Gross Motor Function Measure and subsequently be classified using the Gross Motor Function Classification System and the Manual Ability Classification System.Visual-motor integration will be assessed with the Berry-Buktenica Developmental Test of Visual-Motor Integration.
Measured: DAY 1
Functional profile
Adaptive Behaviour Assessment Systems 3rd Ed.
Measured: DAY 1
Brain profile
Quantitative MRI measuring structural brain integrity
Measured: DAY 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Nov 2023 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Neonatal 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
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Marie Brossard-Racine, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756296
- Sponsor's protocol ID
- MP-37-2023-9320
- Status last verified
- Oct 2023
- First submitted
- 14 Feb 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16221780Levine DS. Neuroexecutive Function. In: Encyclopedia of Human Behavior.2012:701-706
Scarpina F, Tagini S. The Stroop Color and Word Test. Front Psychol. 2017 Apr 12;8:557. doi: 10.3389/fpsyg.2017.00557. eCollection 2017.
PubMed 28446889Deli DC, Kaplan E, Kramer JH. Delis-Kaplan Executive Function System. Pearson Publication Inc; 2001
Rey A. L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie. 1941;28:215-285
Conners CK. Conner Continuous Performance Test - 3rd Ed Pearson Publication Inc.; 2014.
Hunt C, Borgida E, Lavine H. Social Cognition. In: Encyclopedia of Human Behavior.2012:456-462
Korjman M, Kirk U, Kemp S. NEPSY Second Edition (NEPSY-II): A developmental NEuroPSYchological Assessment. Pearson Publication Inc; 2007
Roid GH, Miller LJ. Leither Internaltional Performance Scale - Revised. Wod Dale, IL: Stoelting; 1997
Thompson EJ, Beauchamp MH, Darling SJ, Hearps SJC, Brown A, Charalambous G, Crossley L, Darby D, Dooley JJ, Greenham M, Jaimangal M, McDonald S, Muscara F, Turkstra L, Anderson VA. Protocol for a prospective, school-based standardisation study of a digital social skills assessment tool for children: The Paediatric Evaluation of Emotions, Relationships, and Socialisation (PEERS) study. BMJ Open. 2018 Feb 8;8(2):e016633. doi: 10.1136/bmjopen-2017-016633.
PubMed 29439065Beck J, S., Beck A, T., Jolly J, B. . Beck Youth Inventories - Second Edition. San Antonio, TX: Peason; 2005
Spence SH. Spence Children's Anxiety Scale. Washington, DC: American Psychology Association; 1997
March JS, Parker JD, Sullivan K, Stallings P, Conners CK. The Multidimensional Anxiety Scale for Children (MASC): factor structure, reliability, and validity. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):554-65. doi: 10.1097/00004583-199704000-00019.
PubMed 9100431Gratz KL, Roemer L. Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale. Journal of Pyschopathology and Behavioral Assessment. 2004;26(1):41-54
Russel DJ, Rosenbaum P, Wright M, Avery LM. Gross Motor Function Measure (GMFM-66 & GMFM-88) User's Manual, 2nd Edition. 2nd ed: Mac Keith Press; 2013
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era: Protocol for a Follow-up Cohort Study at 9 Years of Age
- ClinicalTrials.gov ID
- NCT05756296
- Acronym / sponsor ID
- MP-37-2023-9320
- Keywords
- Cerebral Palsy, Brain, Neonate, Developmental Delay, MRI, Child Development
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Mar 2023 (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.
The goal of this study is to characterize the ability and related brain profiles of children with Neonatal encephalopathy (NE) - Therapeutic hypothermia (TH) at 9 years old. The main questions it aims to answer are:
- Compare executive function, attention, social cognition, behaviour, anxiety, self-esteem, and peer problems between children with NE-TH and matched peers without NE.
- Compare brain volumes, cortical and subcortical morphology, white matter microstructure, and myelination between children with NE-TH and matched peers without NE.
- Evaluate the associations of perinatal risk factors and structural brain integrity with neuropsychological deficits to inform about the potential aggravating and protective factors for neuropsychological functioning.
Participants will complete one study visit to perform standardized evaluations and a brain MRI. Parents of participants will be invited to complete a series of questionnaires during this study visit or at a moment of their choice virtually.
Detailed description
Rationale:
Therapeutic hypothermia (TH) became the standard of care treatment for neonates with moderate and severe neonatal encephalopathy (NE) in most industrialized countries about 10 years ago. Although TH is effective in reducing mortality and the incidence of severe developmental disabilities, various morbidities are still frequent in survivors. Moreover, because the focus of previous follow-up studies has been restricted to mortality rates and the most severe forms of morbidities, it is wrong to conclude that TH minimizes all developmental deficits. In fact, recent literature reports frequent cognitive and behavioural difficulties at school entry in children with NE-TH without severe disabilities. Although these difficulties can be less impressive than cerebral palsy and intellectual disability, their negative impacts on a child's self-determination and family well-being are not less important and their nature and extend need to be comprehensively assessed.
Aims and Hypotheses:
- To compare higher-order cognitive, socialization, and psycho-emotional abilities using comprehensive standardized assessments of outcomes between 9-year-old children with NE-TH and age- and sex-matched peers without NE. Hypothesis 1: Children with NE-TH will display lower IQ, executive functioning, attention, social cognition, and self-esteem, but more anxiety and behavioural and peer problems than age- and sex-matched peers without NE-TH.
- To compare structural brain integrity using quantitative MRI between 9-year-old children with NE-TH and age- and sex-matched peers without NE. Hypothesis 2: Children with NE-TH will present with smaller total and regional (basal ganglia, hippocampus, cerebellum) brain volumes, altered cortical and subcortical morphometry, and widespread white matter microstructural and myelination alterations when compared to age- and sex-matched peers without NE-TH.
- To evaluate the relationships between cognitive, psycho-emotional and motor skills at 9 years and (1) individual and perinatal risk factors and (2) structural brain integrity at 9 years.
Hypothesis 3: A combination of individual (e.g., socio-economic), perinatal factors (e.g., neonatal brain injury) and markers of aberrant brain integrity (e.g., volume, microstructure) will be associated with domain-specific deficits at 9 years in children with NE-TH.
Population:
Children born between 2014 and 2018, who received whole-body cooling to an esophageal temperature of 33.5°C initiated within the first 6 hours of life, continued for 72 hours, and then they were slowly rewarmed for moderate or severe NE at one of the two centers will be approached. Eligibility for TH at our institutions followed those established in previous TH trials. Participants with a history of (1) congenital infections, (2) genetic or metabolic disorders, or (3) major brain malformations (e.g., lissencephaly), as well as (4) any contraindication for MRI (e.g., metal implant, claustrophobia), are ineligible.
For each of two same-sex and same-age NE-TH participants, a matched control for age (+/- 6 months of mean age) and sex will be recruited. Participants born at term (gestational age ≥37 weeks), without neonatal complication, will be considered as ineligible controls. Inclusion criteria for the controls include the same were similar to the NE-TH group, and a previous history of neurodevelopmental delay or disorder, or a traumatic brain injury were the specific exclusion cirteria for the comparison group.
Assessment procedure:
For this study, enrollees will complete one study visit to perform standardized evaluations and a brain MRI. Children will have the opportunity to familiarize themselves with the MRI environment on a mock scanner before the MRI and to watch a movie or listen to the music of their choice during the acquisition. Parents will be invited to complete a series of questionnaires during their child's testing or at a moment of their choice via a provided secure link. The visit will start with the outcome evaluations that are the most cognitively demanding and breaks will be provided as necessary. Outcome evaluations will be conducted by trained research staff or trainees blinded to the details of the child's neonatal and developmental history, and group allocation (i.e., NE-TH vs. control) to the extent possible. The choice of outcome measures has been made based on their clinical significance, psychometric properties, and availability in both French and English, considering the bilingual context of Quebec, Canada.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Procedure: Therapeutic hypothermiaChildren aged 9 years old with NE-TH meeting study inclusion criteria. |
| Control group | – | –A comparison group of sex and age matched children with no NE-TH meeting similar study inclusion criteria to intervention group. Specific exclusion criteria for matched control group include a previous history of neurodevelopmental delay or disorder, or a traumatic brain injury, and born at term (gestational age ≥37 weeks), or born without neonatal complication. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Existing clinical cohort of children born between 2014 and 2018, who received TH for NE treated at the two largest neonatal intensive care units and neonatal follow-up programs in Quebec (Canada), the Montreal Children's Hospital (MCH) of the McGill University Health Centre and the Centre Hospitalier Universitaire Ste-Justine (CHUSJ).
Key inclusion criteria (2 listed)
- born between 2014 and 2018
- received whole-body cooling to an esophageal temperature of 33.5°C initiated within the first 6 hours of life, continued for 72 hours, and then they were slowly rewarmed received TH for moderate or severe NE
Key exclusion criteria (5 listed)
- Participants with a history of
- congenital infections
- genetic or metabolic disorders
- major brain malformations (e.g., lissencephaly) and
- any contraindication for MRI (e.g., metal implant, claustrophobia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic hypothermiawhole-body cooling to an esophageal temperature of 33.5°C initiated within the first 6 hours of life, continued for 72 hours, and then they were slowly rewarmed for moderate or severe NE | Procedure or surgery | Intervention group |
Primary outcome
Higher order cognitive abilities
Time frame: DAY 1
Estimated IQ (Wechsler Abbreviated Scale of Intelligence 2nd ed. [WASI-2]), inhibition (Stroop test), planning (Tower - Delis-Kaplan Executive Function System [D-KEFS] and Rey-Osterrieth Complex Figure), impulsivity (Conner Continuous Performance Test - 3rd Ed [CPT-3]), working memory (Digit span), and word retrieval (verbal fluency - D-KEFS). Specific attentional skills; immediate (Digit Span) and sustained attention (CPT-3). Visual memory (Rey-Osterrieth Complex Figure). To characterize the ability to understand that others have thoughts, ideas, and feelings, and how emotion relates to social context, as well as the ability to recognize affect (Theory of Mind and Affect Recognition subtests).
Psycho-emotional abilities
Time frame: DAY 1
Self-esteem (Self-Concept Inventory from the Beck Youth Inventories-II), children's anxiety and emotional regulation (Spence Children's Anxiety Scale, the Multidimensional Anxiety Scale for Children, and the Difficulties in Emotion Regulation Scales). Predominance of profiles (e.g., predominantly affective, cognitive, or generalized) will be examined following an in-depth interpretation of the cognitive and psycho-emotional outcomes.
Motor skills
Time frame: DAY 1
Motor skills will be evaluated using the Movement Assessment Battery for Children-2nd Ed.in children without CP. In children with CP, motor skills will be evaluated with the Gross Motor Function Measure and subsequently be classified using the Gross Motor Function Classification System and the Manual Ability Classification System.Visual-motor integration will be assessed with the Berry-Buktenica Developmental Test of Visual-Motor Integration.
Functional profile
Time frame: DAY 1
Adaptive Behaviour Assessment Systems 3rd Ed.
Brain profile
Time frame: DAY 1
Quantitative MRI measuring structural brain integrity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- 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.
- BackgroundLevine DS. Neuroexecutive Function. In: Encyclopedia of Human Behavior.2012:701-706
- Background: PubMed 28446889Scarpina F, Tagini S. The Stroop Color and Word Test. Front Psychol. 2017 Apr 12;8:557. doi: 10.3389/fpsyg.2017.00557. eCollection 2017.
- BackgroundDeli DC, Kaplan E, Kramer JH. Delis-Kaplan Executive Function System. Pearson Publication Inc; 2001
- BackgroundRey A. L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie. 1941;28:215-285
- BackgroundConners CK. Conner Continuous Performance Test - 3rd Ed Pearson Publication Inc.; 2014.
- BackgroundHunt C, Borgida E, Lavine H. Social Cognition. In: Encyclopedia of Human Behavior.2012:456-462
- BackgroundKorjman M, Kirk U, Kemp S. NEPSY Second Edition (NEPSY-II): A developmental NEuroPSYchological Assessment. Pearson Publication Inc; 2007
- BackgroundRoid GH, Miller LJ. Leither Internaltional Performance Scale - Revised. Wod Dale, IL: Stoelting; 1997
- Background: PubMed 29439065Thompson EJ, Beauchamp MH, Darling SJ, Hearps SJC, Brown A, Charalambous G, Crossley L, Darby D, Dooley JJ, Greenham M, Jaimangal M, McDonald S, Muscara F, Turkstra L, Anderson VA. Protocol for a prospective, school-based standardisation study of a digital social skills assessment tool for children: The Paediatric Evaluation of Emotions, Relationships, and Socialisation (PEERS) study. BMJ Open. 2018 Feb 8;8(2):e016633. doi: 10.1136/bmjopen-2017-016633.
- BackgroundBeck J, S., Beck A, T., Jolly J, B. . Beck Youth Inventories - Second Edition. San Antonio, TX: Peason; 2005
- BackgroundSpence SH. Spence Children's Anxiety Scale. Washington, DC: American Psychology Association; 1997
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Encephalopathy and Therapeutic Hypothermia, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Brossard-Racine, PhD ((514)934-1934 ext. 76295, marie.brossardracine@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Higher order cognitive abilities (time frame: DAY 1). The study lists 5 primary outcomes in all. 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 NCT05756296, which also lists 17 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 23 Oct 2023.