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The PEPaNIC long-term outcome study: Neurocognitive developmental deficit after critical illness in children: role of modifiable epigenetic changes

Completed
Conditions
Kinderen die kritiek ziek zijn geweest en behandeld op Intensive Care
Critical illness / malnutrition
Registration Number
NL-OMON44273
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
885
Inclusion Criteria

The children who are participants in the PEPaNIC study are all eligible for the long-term outcome study.
Healthy controls, recruited for an identical follow-up programme, will be demographically (primarily age, gender and ethnicity) matched to the PEPaNIC study participants.
The inclusion criteria for the healthy controls are:
* Same gender proportion as the cases
* Same age range as the cases
* Same social-economic status

Exclusion Criteria

No exclusion criteria, other than 'no consent', are applicable for the PEPaNIC patients. The exclusion criteria for the healthy controls are:
* History of neonatal or paediatric intensive care admission
* History of parenteral nutrition

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary goal of the PEPaNIC long-term outcome study is to determine the<br /><br>long-term neurocognitive outcome (more specifically the IQ-scores, motor and<br /><br>executive function) of critical illness and the effect hereon of artificial<br /><br>nutrition provided during the acute phase of critical illness in children. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>to determine the effect on:<br /><br>-anthropometrics (legnth, weight, arm-leg circumference)<br /><br>-neuro-endocrine axes (hair, blood)<br /><br>-epigenetic modifications (white blood cells / saliva / mucosal swab)<br /><br>-health economics; eg healthy care consumptions, CUA etc.<br /><br>-endurance/activity</p><br>
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