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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38736

Enrollment

210

Registered

2013-10-15

Start date

2014-01-08

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

birth defects congenital anomalies

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The aim of our study is to assess brain injury using cranial ultrasound (cUS) and cerebral magnetic resonance imaging (MRI). The primary outcome parameter is defined as difusion weighted imaging (DWI) abnormalities in order to evaluate acute brain injury from hypoxic-ischemic events and alterations in cerebral perfusion and oxygenation.	—

Secondary

Measure	Time frame
Main study parameters/endpoints: The primary endpoints of this study are: a. Brain injury diagnosed using cranial ultrasound (cUS) and cerebral magnetic resonance imaging (MRI). Secondary endpoints consist of: a. Evaluation of the value of biomarkers for neuronal injury (i.e. S100B, NSE, B-FABP, neuroketal), oxidative stress (NPBI and 8-isoprostane) and inflammation (luminex) in predicting timing of (hypoxic-ischemic) brain injury during neonatal surgery. b. Neurodevelopmental outcome at 24 months corrected age, measured by Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III). Other study parameters are: Perioperative details about the anesthetic regimen, vital signs, and aEEG and NIRS data will be collected and analysed in relation to brain injury, in order to identify associations between perioperative parameters and potential brain injury. In addition, a detailed medical chart review will be performed and perinatal and demographic data will also be collected and analysed in relation to potential brain injury, in order to find patterns and associations between perinatal, demographic and perioperative parameters and the primary outcome measure.	—

Measure

Time frame

Main study parameters/endpoints: The primary endpoints of this study are: a. Brain injury diagnosed using cranial ultrasound (cUS) and cerebral magnetic resonance imaging (MRI). Secondary endpoints consist of: a. Evaluation of the value of biomarkers for neuronal injury (i.e. S100B, NSE, B-FABP, neuroketal), oxidative stress (NPBI and 8-isoprostane) and inflammation (luminex) in predicting timing of (hypoxic-ischemic) brain injury during neonatal surgery. b. Neurodevelopmental outcome at 24 months corrected age, measured by Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III). Other study parameters are: Perioperative details about the anesthetic regimen, vital signs, and aEEG and NIRS data will be collected and analysed in relation to brain injury, in order to identify associations between perioperative parameters and potential brain injury. In addition, a detailed medical chart review will be performed and perinatal and demographic data will also be collected and analysed in relation to potential brain injury, in order to find patterns and associations between perinatal, demographic and perioperative parameters and the primary outcome measure.

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Countries

Netherlands

Outcome results