[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559181":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":10,"centralContacts":42,"locations":10,"responsibleParty":48,"collaborators":52,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":10,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":10,"maxAge":65,"enrollmentInfo":66,"targetDuration":69,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":82,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":10},{"fullName":5,"class":6},"University College, London","OTHER",[8,14,18,22,26,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Case group 1: Children with Open Spina Bifida and Chiari II Malformation",null,"CSF will be collected during postnatal surgical repair at Great Ormond Street Hospital (GOSH)",[13],"Other: collection of cerebrospinal fluid",{"label":15,"type":10,"description":16,"interventionNames":17},"Control group 1: Newborns with hydrocephalus undergoing shunt surgery, unrelated to spina bifida","CSF will be collected during suregry at GOSH",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Control group 1bis: Infants undergoing spinal surgery for conditions other than SB","CSF will be collected during surgery at GOSH.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Case group 2: Fetuses Undergoing Prenatal Surgery for Spina Bifida","CSF will be collected during prenatal surgery at University College London Hospitals (UCLH).",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Control group 2: Aborted fetuses within the gestational age range of 22-24 weeks,","CSF will be collected from fetuses provided by the Human Developmental Biology Resource (HDBR).",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Case group 3: mouse model of spina bifida (Cdx2Cre x Pax3flox)","CSF will be collected",[13],{"label":35,"type":10,"description":32,"interventionNames":36},"Control group 3: normal (wild-type) mice",[13],[38],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"collection of cerebrospinal fluid","CSF is collected as part of routine care in any of the surgeries listed in the control or cases groups. We will take part of that CSF for proteomic analysis",[9,23,31,15,19,27,35],[43],{"name":44,"role":45,"phone":46,"phoneExt":10,"email":47},"Andrew Copp, PhD","CONTACT","02079052698","a.copp@ucl.ac.uk",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Amparo Saenz","PhD student and pediatric neurosurgeon",[53,55],{"name":54,"class":6},"Great Ormond Street Hospital for Children NHS Foundation Trust",{"name":56,"class":6},"University College London Hospitals","100559181","the-role-of-csf-in-chiari-ii-brain-malformation-100559181",false,"NCT06560788","The Role of CSF in Chiari II Brain Malformation","Chiari II Brain Malformation: The Role of Cerebrospinal Fluid in Neurodevelopmental Defects Associated With Spina Bifida","Inclusion Criteria:\n\nNewborns with Spina Bifida (Postnatal Closure)\n\n* Diagnosed with open spina bifida (myelomeningocele).\n* Scheduled for postnatal surgical closure of the spinal lesion at Great Ormond Street Hospital (GOSH).\n* Age: Between 1 day to 1 year old.\n\nControl Group 1 (Newborns with Hydrocephalus)\n\n* Newborns scheduled for shunt surgery for hydrocephalus unrelated to spina bifida.\n* Age and sex matched to the spina bifida newborns as closely as possible.\n* Age: Between 1 day to 1 year old.\n\nControl Group 2 (Infants with Spinal Conditions Unrelated to Spina Bifida)\n\n* Infants undergoing paned spinal surgery for conditions such as spinal lipoma, fatty filum, tethered cord, etc.\n* Age and sex matched to the spina bifida newborns as closely as possible.\n* Age: Between 1 day to 1 year old. Fetuses with Spina Bifida (Prenatal Closure)\n* Prenatal diagnosis of spina bifida (myelomeningocele) and scheduled for fetal surgery at UCLH.\n* Reviewed by Mr Thompson at his outpatient clinic at GOSH\n* Gestational age: Between 22 and 24 weeks.\n\nControl Fetal Samples\n\n* Aborted fetuses within the gestational age range of 22-24 weeks.\n* Samples obtained through the Human Developmental Biology Resource (HDBR).\n\nMouse Models\n\n* Genetic mouse model of spina bifida (Cdx2Cre x Pax3flox).\n* At embryonic day (E)13.5 (end of the embryonic period) and E18.5 (just before birth)\n\nControl Mouse Models\n\n* Normal (wild-type) mice to serve as controls.\n* Normal brain development\n* At embryonic day (E)13.5 (end of the embryonic period) and E18.5 (just before birth)\n\nExclusion Criteria:\n\nNewborns with Spina Bifida (Postnatal Closure)\n\n* Newborns who have undergone previous surgical intervention.\n* Presence of additional unrelated congenital anomalies that could affect cerebrospinal fluid (CSF) composition like meningitis or intraventricular bleeding\n* Older than 1 year and 1 month of age.\n* Parents refused to participate\n* Native language different to English with no translation services available\n\nControl Group 1 (Newborns with Hydrocephalus)\n\n* Newborns with hydrocephalus caused by spina bifida.\n* Presence of intraventricular infection or haemorrhage.\n* Older than 1 year and 1 month of age.\n* Parents refused to participate\n* Native language different to English with no translation services available\n\nControl Group 2 (Infants with Spinal Conditions Unrelated to Spina Bifida)\n\n* Infants who were born with spina bifida\n* Infants with coexisting conditions that could affect CSF composition like intraspinal tumours, empyema or haemorrhage.\n* Older than 1 year and 1 month of age.\n* Parents refused to participate\n* Native language different to English with no translation services available\n\nFetuses with Spina Bifida (Prenatal Closure)\n\n* Fetuses with additional major anomalies unrelated to spina bifida like diaphragmatic hernia.\n* Gestational age outside the range of 22-24 weeks.\n* Surgery performed by other neurosurgery team (not GOSH)\n* Parents refused to participate\n* Native language different to English with no translation services available\n\nControl Fetal Samples\n\n* Poorly preserved aborted fetuses not suitable for CSF collection.\n* Gestational age outside the range 22-24 weeks.\n\nMouse Models\n\n* Mice with any genetic modifications other than those specified for the spina bifida model.\n* Mice with other congenital or acquired anomalies affecting the central nervous system.\n\nControl Mouse Models\n\n● Mice with any genetic modifications or health conditions that could influence the study's outcomes.","ALL","1 Year",{"count":67,"type":68},18,"ESTIMATED","1 Day","OBSERVATIONAL","Spina bifida, particularly its most severe form known as open spina bifida (myelomeningocele), is a significant congenital disorder that results in profound neurological impairments, including Chiari II malformation. This malformation is associated with the downward displacement of the cerebellum and brainstem into the spinal canal, often leading to hydrocephalus, a condition where cerebrospinal fluid (CSF) accumulates in the brain1. These conditions can result in a range of complications, including cognitive and motor disabilities, learning difficulties, and, in severe cases, early mortality1,2.\n\nWhile surgical interventions, including prenatal and postnatal surgeries, have been developed to manage the physical manifestations of spina bifida and Chiari II malformation, these procedures have not been fully successful in addressing the associated brain anomalies3. This study aims to explore the hypothesis that the composition of CSF plays a critical role in the development of these brain defects. Specifically, it is hypothesized that the rapid replenishment of CSF, due to its leakage from the open spine in spina bifida, results in a \"less mature\" fluid composition, which negatively affects neurogenesis and neuronal migration during critical periods of brain development.",[73,74,75],"Myelomeningocele","Brain Malformation","Chiari Malformation Type 2",[77,78,79,80,81],"myelomeningocele","Chiari type 2","brain malformations","cognitive impairment","cerebrospinal fluid","NOT_YET_RECRUITING","2024-08-19",{"date":85,"type":86},"2024-08-21","ACTUAL",{"date":88,"type":68},"2024-09-01",{"date":90,"type":68},"2027-08-01",{"name":5,"class":6}]