Long-term consequences of neonatal encephalopathy in the hypothermia era: protocol for a follow-up cohort study at 9 years of age
Introduction 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 disabilitie...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/4/e073063.full |
| _version_ | 1797847270341738496 |
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| author | Thuy Mai Luu Pia Wintermark Guillaume Gilbert Marie Brossard-Racine Emmanouille Rampakakis Christine Lucas Tardif Angela White Anne Gallagher Elana Pinchefsky Tina Montreuil Marie-Noelle Simard |
| author_facet | Thuy Mai Luu Pia Wintermark Guillaume Gilbert Marie Brossard-Racine Emmanouille Rampakakis Christine Lucas Tardif Angela White Anne Gallagher Elana Pinchefsky Tina Montreuil Marie-Noelle Simard |
| author_sort | Thuy Mai Luu |
| collection | DOAJ |
| description | Introduction 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, the recent literature converges in reporting frequent cognitive and behavioural difficulties at school entry in children with NE-TH. Although these challenges are deemed minor compared with cerebral palsy and intellectual disability, their impacts on a child’s self-determination and family’s well-being are quite significant. Therefore, the nature and extent of these difficulties need to be comprehensively described so that appropriate care can be offered.Methods and analysis The current study will be the largest follow-up study of neonates with NE treated with TH to characterize their developmental outcomes and associated brain structural profiles at 9 years of age. Specifically, we will compare executive function, attention, social cognition, behaviour, anxiety, self-esteem, peer problems, brain volume, cortical features, white matter microstructure and myelination between children with NE-TH and matched peers without NE. Associations of perinatal risk factors and structural brain integrity with cognitive, behavioural and psycho-emotional deficits will be evaluated to inform about the potential aggravating and protective factors associated with function.Ethics and dissemination This study is supported by the Canadian Institute of Health Research (202203PJT-480065-CHI-CFAC-168509), and received approval from the Pediatric Ethical Review Board of the McGill University Health Center (MP-37-2023-9320). The study findings will be disseminated in scientific journals and conferences and presented to parental associations and healthcare providers to inform best practices.Trial registration number NCT05756296. |
| first_indexed | 2024-04-09T18:09:44Z |
| format | Article |
| id | doaj.art-16243aefc01e4e9fbde2fde22324fa0c |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-09T18:09:44Z |
| publishDate | 2023-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-16243aefc01e4e9fbde2fde22324fa0c2023-04-14T03:00:07ZengBMJ Publishing GroupBMJ Open2044-60552023-04-0113410.1136/bmjopen-2023-073063Long-term consequences of neonatal encephalopathy in the hypothermia era: protocol for a follow-up cohort study at 9 years of ageThuy Mai Luu0Pia Wintermark1Guillaume Gilbert2Marie Brossard-Racine3Emmanouille Rampakakis4Christine Lucas Tardif5Angela White6Anne Gallagher7Elana Pinchefsky8Tina Montreuil9Marie-Noelle Simard1010 Department of Pediatrics, Universite de Montreal, Montreal, Quebec, CanadaDivision of Newborn Medicine, Children`s Hospital Boston, Boston, Massachusetts, USAMR Clinical Science, Philips Canada, Mississauga, Ontario, CanadaSchool of Physical and Occupational Therapy, McGill University, Montreal, Quebec, CanadaDepartment of Pediatrics, McGill University Health Centre, Montreal, Quebec, CanadaMontreal Neurological Institute-Hospital, Montreal, Quebec, CanadaResearch Institute of the McGill University Health Centre, Montreal, Quebec, CanadaCentre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, CanadaCentre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, CanadaDepartment of Psychiatry, McGill University Montreal, Montreal, Quebec, CanadaCentre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, CanadaIntroduction 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, the recent literature converges in reporting frequent cognitive and behavioural difficulties at school entry in children with NE-TH. Although these challenges are deemed minor compared with cerebral palsy and intellectual disability, their impacts on a child’s self-determination and family’s well-being are quite significant. Therefore, the nature and extent of these difficulties need to be comprehensively described so that appropriate care can be offered.Methods and analysis The current study will be the largest follow-up study of neonates with NE treated with TH to characterize their developmental outcomes and associated brain structural profiles at 9 years of age. Specifically, we will compare executive function, attention, social cognition, behaviour, anxiety, self-esteem, peer problems, brain volume, cortical features, white matter microstructure and myelination between children with NE-TH and matched peers without NE. Associations of perinatal risk factors and structural brain integrity with cognitive, behavioural and psycho-emotional deficits will be evaluated to inform about the potential aggravating and protective factors associated with function.Ethics and dissemination This study is supported by the Canadian Institute of Health Research (202203PJT-480065-CHI-CFAC-168509), and received approval from the Pediatric Ethical Review Board of the McGill University Health Center (MP-37-2023-9320). The study findings will be disseminated in scientific journals and conferences and presented to parental associations and healthcare providers to inform best practices.Trial registration number NCT05756296.https://bmjopen.bmj.com/content/13/4/e073063.full |
| spellingShingle | Thuy Mai Luu Pia Wintermark Guillaume Gilbert Marie Brossard-Racine Emmanouille Rampakakis Christine Lucas Tardif Angela White Anne Gallagher Elana Pinchefsky Tina Montreuil Marie-Noelle Simard Long-term consequences of neonatal encephalopathy in the hypothermia era: protocol for a follow-up cohort study at 9 years of age BMJ Open |
| title | Long-term consequences of neonatal encephalopathy in the hypothermia era: protocol for a follow-up cohort study at 9 years of age |
| title_full | Long-term consequences of neonatal encephalopathy in the hypothermia era: protocol for a follow-up cohort study at 9 years of age |
| title_fullStr | Long-term consequences of neonatal encephalopathy in the hypothermia era: protocol for a follow-up cohort study at 9 years of age |
| title_full_unstemmed | Long-term consequences of neonatal encephalopathy in the hypothermia era: protocol for a follow-up cohort study at 9 years of age |
| title_short | Long-term consequences of neonatal encephalopathy in the hypothermia era: protocol for a follow-up cohort study at 9 years of age |
| title_sort | long term consequences of neonatal encephalopathy in the hypothermia era protocol for a follow up cohort study at 9 years of age |
| url | https://bmjopen.bmj.com/content/13/4/e073063.full |
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