Comparison of school-age outcome in children with a history of perinatal asphyxia with and without hypothermia therapy with controls

Comparison of school-age outcome in children with a history of perinatal asphyxia with and without hypothermia therapy with controls - Resting-state fMRI following perinatal asphyxia with or without hypothermia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47459

Enrollment

Registered

2015-01-26

Start date

2017-01-26

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

perinatal asphyxia

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: a) 40 full-term infants admitted to a NICU (UMCU or Isala) in the period of 2007-2008 because of acute perinatal asphyxia but without hypothermia and b) 40 fullterm infants admitted to a NICU (UMCU or Isala) in the period of 2008-2009 because of acute perinatal asphyxia but treated with hypothermia

Exclusion criteria

Exclusion criteria: - Moderate to severe structural brain damage previously confirmed by MRI; - Congenital brain abnormalities and/or other (chromosomal/metabolic) anomalies; - Cerebral palsy; - Abnormal developmental outcome (DQ

Design outcomes

Primary

Measure	Time frame
Neuropsychological assessment: comparison of neurospychological outcome assessed at 9-10 years of age in children who suffered perinatal asphyxia, were treated /or not with hypothermia in the neonatal period MRI. Conventional MR imaging will be evaluated for presence of structural abnormalities. From the resting-state fMRI sequence, cross-correlation calculations between resting-state time series of spatially distant brain areas can determine functional connectivity (FC) between brain areas. Next to network localization, network size and FC strength will be studied.	—

Measure

Time frame

Neuropsychological assessment: comparison of neurospychological outcome assessed at 9-10 years of age in children who suffered perinatal asphyxia, were treated /or not with hypothermia in the neonatal period MRI. Conventional MR imaging will be evaluated for presence of structural abnormalities. From the resting-state fMRI sequence, cross-correlation calculations between resting-state time series of spatially distant brain areas can determine functional connectivity (FC) between brain areas. Next to network localization, network size and FC strength will be studied.

—

Secondary

Measure	Time frame
MRI Comparison of cross-correlation calculations between resting-state time series of spatially distant brain areas can determine functional connectivity (FC) between brain areas. Next to network localization, network size and FC strength will be studied in infants with and without perinatal asphyxia. Comparison of the results of the neuropsychological evaluation with the results of the test using the virtual reality glasses. .	—

Measure

Time frame

MRI Comparison of cross-correlation calculations between resting-state time series of spatially distant brain areas can determine functional connectivity (FC) between brain areas. Next to network localization, network size and FC strength will be studied in infants with and without perinatal asphyxia. Comparison of the results of the neuropsychological evaluation with the results of the test using the virtual reality glasses. .

—

Countries

Netherlands

Outcome results