The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era

NCT05756296 | Not Yet Recruiting

• 1 other identifier: MP-37-2023-9320
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 2

Brief 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. 1.Compare executive function, attention, social cognition, behaviour, anxiety, self-esteem, and peer problems between children with NE-TH and matched peers without NE.
2. 2.Compare brain volumes, cortical and subcortical morphology, white matter microstructure, and myelination between children with NE-TH and matched peers without NE.
3. 3.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.

Conditions

Neonatal Encephalopathy; Therapeutic Hypothermia; Brain Injuries; Child Development

Keywords

Cerebral Palsy; Brain; Neonate; Developmental Delay; MRI; Child Development

Outcome Measures

Primary Outcomes (5)

• 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).

  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.

  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.

  DAY 1

• Functional profile

  Adaptive Behaviour Assessment Systems 3rd Ed.

  DAY 1

• Brain profile

  Quantitative MRI measuring structural brain integrity

  DAY 1

Other Outcomes (4)

• Sex

  DAY 1

• Gender

  DAY 1

• Socio-economic status

  DAY 1

Study Arms (2)

Intervention group

Children aged 9 years old with NE-TH meeting study inclusion criteria.

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.

Interventions

Therapeutic hypothermia PROCEDURE

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

Intervention group

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Centre Hospitalier Universitaire Ste-Justine (CHUSJ).

Montreal, Quebec, H3T 1C5, Canada

Location

the Montreal Children's Hospital (MCH) of the McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (17)

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  PMID: 16221780 BACKGROUND

• Levine DS. Neuroexecutive Function. In: Encyclopedia of Human Behavior.2012:701-706

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• 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.

  PMID: 28446889 BACKGROUND

• Deli DC, Kaplan E, Kramer JH. Delis-Kaplan Executive Function System. Pearson Publication Inc; 2001

  BACKGROUND

• 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

  BACKGROUND

• Conners CK. Conner Continuous Performance Test - 3rd Ed Pearson Publication Inc.; 2014.

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• Hunt C, Borgida E, Lavine H. Social Cognition. In: Encyclopedia of Human Behavior.2012:456-462

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• Korjman M, Kirk U, Kemp S. NEPSY Second Edition (NEPSY-II): A developmental NEuroPSYchological Assessment. Pearson Publication Inc; 2007

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• Roid GH, Miller LJ. Leither Internaltional Performance Scale - Revised. Wod Dale, IL: Stoelting; 1997

  BACKGROUND

• 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.

  PMID: 29439065 BACKGROUND

• Beck J, S., Beck A, T., Jolly J, B. . Beck Youth Inventories - Second Edition. San Antonio, TX: Peason; 2005

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• Spence SH. Spence Children's Anxiety Scale. Washington, DC: American Psychology Association; 1997

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• 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.

  PMID: 9100431 BACKGROUND

• Gratz 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

  BACKGROUND

• 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

  BACKGROUND

• Harrison P, Oakland T. Adaptive Behavior Assessment Systems 3rd Ed. Pearson Publication Inc; 2015.

  BACKGROUND

• Brossard-Racine M, Rampakakis E, Tardif CL, Gilbert G, White A, Luu TM, Gallagher A, Pinchefsky E, Montreuil T, Simard MN, Wintermark P. Long-term consequences of neonatal encephalopathy in the hypothermia era: protocol for a follow-up cohort study at 9 years of age. BMJ Open. 2023 Apr 13;13(4):e073063. doi: 10.1136/bmjopen-2023-073063.

  PMID: 37055215 DERIVED

MeSH Terms

Conditions

Brain Injuries; Cerebral Palsy; Learning Disabilities

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics

Central Study Contacts

Marie Brossard-Racine, PhD

CONTACT

(514)934-1934; marie.brossardracine@mcgill.ca

Study Design

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

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 6, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

CA (2)