The Role of CSF in Chiari II Brain Malformation
- Conditions
- MyelomeningoceleBrain MalformationChiari Malformation Type 2
- Registration Number
- NCT06560788
- Lead Sponsor
- University College, London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>Newborns with Spina Bifida (Postnatal Closure)<br><br> - Diagnosed with open spina bifida (myelomeningocele).<br><br> - Scheduled for postnatal surgical closure of the spinal lesion at Great Ormond Street<br> Hospital (GOSH).<br><br> - Age: Between 1 day to 1 year old.<br><br>Control Group 1 (Newborns with Hydrocephalus)<br><br> - Newborns scheduled for shunt surgery for hydrocephalus unrelated to spina bifida.<br><br> - Age and sex matched to the spina bifida newborns as closely as possible.<br><br> - Age: Between 1 day to 1 year old.<br><br>Control Group 2 (Infants with Spinal Conditions Unrelated to Spina Bifida)<br><br> - Infants undergoing paned spinal surgery for conditions such as spinal lipoma, fatty<br> filum, tethered cord, etc.<br><br> - Age and sex matched to the spina bifida newborns as closely as possible.<br><br> - Age: Between 1 day to 1 year old. Fetuses with Spina Bifida (Prenatal Closure)<br><br> - Prenatal diagnosis of spina bifida (myelomeningocele) and scheduled for fetal<br> surgery at UCLH.<br><br> - Reviewed by Mr Thompson at his outpatient clinic at GOSH<br><br> - Gestational age: Between 22 and 24 weeks.<br><br>Control Fetal Samples<br><br> - Aborted fetuses within the gestational age range of 22-24 weeks.<br><br> - Samples obtained through the Human Developmental Biology Resource (HDBR).<br><br>Mouse Models<br><br> - Genetic mouse model of spina bifida (Cdx2Cre x Pax3flox).<br><br> - At embryonic day (E)13.5 (end of the embryonic period) and E18.5 (just before birth)<br><br>Control Mouse Models<br><br> - Normal (wild-type) mice to serve as controls.<br><br> - Normal brain development<br><br> - At embryonic day (E)13.5 (end of the embryonic period) and E18.5 (just before birth)<br><br>Exclusion Criteria:<br><br>Newborns with Spina Bifida (Postnatal Closure)<br><br> - Newborns who have undergone previous surgical intervention.<br><br> - Presence of additional unrelated congenital anomalies that could affect<br> cerebrospinal fluid (CSF) composition like meningitis or intraventricular bleeding<br><br> - Older than 1 year and 1 month of age.<br><br> - Parents refused to participate<br><br> - Native language different to English with no translation services available<br><br>Control Group 1 (Newborns with Hydrocephalus)<br><br> - Newborns with hydrocephalus caused by spina bifida.<br><br> - Presence of intraventricular infection or haemorrhage.<br><br> - Older than 1 year and 1 month of age.<br><br> - Parents refused to participate<br><br> - Native language different to English with no translation services available<br><br>Control Group 2 (Infants with Spinal Conditions Unrelated to Spina Bifida)<br><br> - Infants who were born with spina bifida<br><br> - Infants with coexisting conditions that could affect CSF composition like<br> intraspinal tumours, empyema or haemorrhage.<br><br> - Older than 1 year and 1 month of age.<br><br> - Parents refused to participate<br><br> - Native language different to English with no translation services available<br><br>Fetuses with Spina Bifida (Prenatal Closure)<br><br> - Fetuses with additional major anomalies unrelated to spina bifida like diaphragmatic<br> hernia.<br><br> - Gestational age outside the range of 22-24 weeks.<br><br> - Surgery performed by other neurosurgery team (not GOSH)<br><br> - Parents refused to participate<br><br> - Native language different to English with no translation services available<br><br>Control Fetal Samples<br><br> - Poorly preserved aborted fetuses not suitable for CSF collection.<br><br> - Gestational age outside the range 22-24 weeks.<br><br>Mouse Models<br><br> - Mice with any genetic modifications other than those specified for the spina bifida<br> model.<br><br> - Mice with other congenital or acquired anomalies affecting the central nervous<br> system.<br><br>Control Mouse Models<br><br>? Mice with any genetic modifications or health conditions that could influence the<br>study's outcomes.
Not provided
Study & Design
- Study Type
- Observational [Patient Registry]
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of Proteins in Cerebrospinal Fluid (CSF);Quantification of Protein Concentrations in Cerebrospinal Fluid (CSF)
- Secondary Outcome Measures
Name Time Method Measurement of Neurogenesis in Median Ganglionic Eminence (MGE) Cultures;Measurement of Neuronal Migration in Median Ganglionic Eminence (MGE) Cultures