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Cerebral monitoring during neonatal surgery for non-cardiac congenital anomalies: a first step to improve outcome?

Completed
Conditions
birth defects
congenital anomalies
10017998
10010335
Registration Number
NL-OMON38736
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
210
Inclusion Criteria

Infants with non-cardiac congenital anomalies requiring surgery in the first 28 days of life. Congenital birth defects include for example:
1. esophageal atresia or trachea-esophageal fistula
2. congenital diaphragmatic hernia
3. intestinal atresia
4. anorectal malformation
5. Hirschsprung disease
6. malrotation/volvulus
7. abdominal wall defects (gastroschisis, omphalocele)
8. biliary atresia
9. congenital hydronephrosis
10. Pierre Robin sequence
11. choanal atresia

Exclusion Criteria

Custodial parent(s) or guardian with insufficient Dutch language proficiency.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The aim of our study is to assess brain injury using cranial ultrasound (cUS)<br /><br>and cerebral magnetic resonance imaging (MRI). The primary outcome parameter<br /><br>is defined as difusion weighted imaging (DWI) abnormalities in order to<br /><br>evaluate acute brain injury from hypoxic-ischemic events and alterations in<br /><br>cerebral perfusion and oxygenation.</p><br>
Secondary Outcome Measures
NameTimeMethod
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