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

Systematic Hospital-based Assessment of Rotterdam*s critically Ill children, their Neurodevelopment and Growth - S.H.A.R.I.N.G.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52751

Enrollment

Registered

2020-03-10

Start date

2022-06-16

Completion date

Unknown

Last updated

2025-11-10

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

Conditions

Neonatal critical illness

Interventions

None listed

Eligibility

Age

No minimum to 11 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The main study parameter is the relationship between hippocampal volume before discharge and memory at five and eight years of age in all subjects.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results