Follow-up of Inflammatory Responses and Multiorgan Outcomes FoLlowing Neonatal Brain injurY
NCT ID: NCT04816331
Last Updated: 2021-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2020-08-04
2022-09-30
Brief Summary
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Inflammation is an important factor in brain injury of newborns and also affects their heart lungs and other parts of their body. The investigators will use tests from the newborn period to predict outcome and help parents with planning health needs for their baby rather than waiting until any issues arise later on. By understanding inflammation the investigators can find methods to decrease the negative effects and improve outcomes in the future for babies and families.
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Detailed Description
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The investigators aim to examine multi-organ dysfunction in early childhood in children who had NE by examining detailed cardiac, renal, neurological, haematological and neurodevelopmental outcomes. The investigators have previously defined detailed multi organ dysfunction (MOD) in this cohort in the neonatal period in infants with NE including organ outcomes as well as serum, urine and cerebrospinal fluid (CSF) biomarkers. They are now age-appropriate for detailed neurocognitive assessment and correlation with these biomarkers and the investigators plan to compare with age- matched controls. Immunological markers such as the inflammasome and microRNAs are altered in the neonatal period and may persist in early childhood. The investigators will modify negative inflammatory responses in vitro with specific antagonists as well as correlating these immune biomarkers with outcomes.
Quantifying multiorgan dysfunction in the neonatal period to ensure appropriate follow-up of all organs is merited. This would help in advanced clinical planning and long term follow up. In addition, understanding, the immune response in these children with NE and exploring systemic inflammation holds promise for future development of immunomodulatory adjunctive therapies and biomarkers to predict outcomes.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Neonatal Encephalopathy (NE)
This study is a follow up of children at 2-3 years of age who were enrolled in the HRB-funded Neonatal Inflammation and Multiorgan dysfunction and Brain injUry reSearch group (NIMBUS) project. These babies had Neonatal Encephalopathy and required Therapeutic Hypothermia and are matched with controls. Detailed antenatal, birth, resuscitation, oxygen requirements throughout inpatient stay and detailed neonatal intensive care management were collected. In addition, details of Therapeutic Hypothermia treatment including initiation, duration and clinical examination, investigations including cranial USS, MRI, EEG and placental histology analysis performed as were recorded.
Medical records and clinical measurements
Medical records and clinical measurements: Detailed antenatal, birth, resuscitation, oxygen requirements throughout inpatient stay and detailed neonatal intensive care management will be collected. Therapeutic Hypothermia treatment including initiation, duration and clinical examination, and investigations such as scans. In addition, clinical data will include medication, neurological (paediatric developmental psychologist assessment and Bayley Scales of Infant and Toddler Development) and multiorgan examination.
Questionnaires for caregivers to assess social-emotional and adaptive domains.
Tissue samples analysis and processing: Samples of blood, urine and saliva will be used for laboratory testing.
Biomarker correlation with Multiorgan outcomes using statistical analysis: Data collected from medical records, clinical measurements, questionnaires, and tissue processing will be analysed using SPSS software for statistical analysis and modelling.
Controls
The controls include age-matched normal children born at term with a normal delivery and postnatal course.
Medical records and clinical measurements
Medical records and clinical measurements: Detailed antenatal, birth, resuscitation, oxygen requirements throughout inpatient stay and detailed neonatal intensive care management will be collected. Therapeutic Hypothermia treatment including initiation, duration and clinical examination, and investigations such as scans. In addition, clinical data will include medication, neurological (paediatric developmental psychologist assessment and Bayley Scales of Infant and Toddler Development) and multiorgan examination.
Questionnaires for caregivers to assess social-emotional and adaptive domains.
Tissue samples analysis and processing: Samples of blood, urine and saliva will be used for laboratory testing.
Biomarker correlation with Multiorgan outcomes using statistical analysis: Data collected from medical records, clinical measurements, questionnaires, and tissue processing will be analysed using SPSS software for statistical analysis and modelling.
Interventions
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Medical records and clinical measurements
Medical records and clinical measurements: Detailed antenatal, birth, resuscitation, oxygen requirements throughout inpatient stay and detailed neonatal intensive care management will be collected. Therapeutic Hypothermia treatment including initiation, duration and clinical examination, and investigations such as scans. In addition, clinical data will include medication, neurological (paediatric developmental psychologist assessment and Bayley Scales of Infant and Toddler Development) and multiorgan examination.
Questionnaires for caregivers to assess social-emotional and adaptive domains.
Tissue samples analysis and processing: Samples of blood, urine and saliva will be used for laboratory testing.
Biomarker correlation with Multiorgan outcomes using statistical analysis: Data collected from medical records, clinical measurements, questionnaires, and tissue processing will be analysed using SPSS software for statistical analysis and modelling.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With diagnosis of Neonatal Encephalopathy
* Required Therapeutic Hypothermia
Exclusion Criteria
2 Years
3 Years
ALL
Yes
Sponsors
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Health Research Board, Ireland
OTHER
University of Dublin, Trinity College
OTHER
Responsible Party
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Prof. Eleanor Molloy
Professor of Paediatrics & Child Health, Paediatrics
Principal Investigators
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Eleanor Molloy, Prof.
Role: PRINCIPAL_INVESTIGATOR
Professor of Paediatrics & Child Health, Paediatrics
Locations
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The Coombe Women & Infants University Hospital
Dublin, , Ireland
The National Maternity Hospital, or Holles Street Hospital
Dublin, , Ireland
The Rotunda Hospital
Dublin, , Ireland
The Tallaght University Hospital
Dublin, , Ireland
Trinity College Dublin, The University of Dublin
Dublin, , Ireland
Countries
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References
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Other Identifiers
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ILP-POR-2019-086
Identifier Type: -
Identifier Source: org_study_id
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