Systematic Hospital-based Assessment of Rotterdam*s critically Ill children, their Neurodevelopment and Growth

Recruiting

Conditions: Neonatal critical illness
10007510
10028920
10028971

Registration Number: NL-OMON52751

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 55

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet the
following criteria:
- Admitted within the first 2 days of life to the NICU or PICU of Erasmus
MC-Sophia Children*s hospital, and:
- Born between 24-28 weeks of gestation, or;
- Born with complex congenital cardiac anomalies (i.e. aortic arch anomalies;
univentricular hearts; transposition of the great arteries), or;
- Born with congenital diaphragmatic hernia, or;
- Neonatal severe respiratory failure in need of treatment with extracorporeal
membrane oxygenation within the first 28 days of life

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Syndromes known to affect neurodevelopment
- For the MRI: metal implants (e.g. certain pacemakers), claustrophobia or
other problems such as movement disorders.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the relationship between hippocampal volume before<br /><br>discharge and memory at five and eight years of age in all subjects. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The association between factors associated with critical illness (e.g.<br /><br>hypoxia, hyperoxia, anesthetic and analgosedative exposure) and severity of<br /><br>illness (e.g. duration of ICU admission, PRISM, PIM, SNAP-II, VIS) and<br /><br>hippocampal volume at eight years of age<br /><br>- The association between factors associated with critical illness (e.g.<br /><br>hypoxia, hyperoxia, anesthetic and analgosedative exposure) and severity of<br /><br>illness (e.g. PRISM, PIM, SNAP-II, VIS) and memory at five and eight years of<br /><br>age<br /><br>- The difference between hippocampal development between the survivors of<br /><br>neonatal critical illness and healthy controls (Generation R NEXT population)<br /><br>- The difference between memory outcome between the survivors of neonatal<br /><br>critical illness and the reference population (Dutch normative data)</p><br>