Status:
NOT_YET_RECRUITING
The Role of CSF in Chiari II Brain Malformation
Lead Sponsor:
University College, London
Collaborating Sponsors:
Great Ormond Street Hospital for Children NHS Foundation Trust
University College London Hospitals
Conditions:
Myelomeningocele
Brain Malformation
Eligibility:
All Genders
Up to 1 years
Brief Summary
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 ...
Detailed Description
Study Population and Methodology This prospective case-control study will involve the collection of CSF samples from several groups, including: 1. Newborns with open spina bifida undergoing postnata...
Eligibility Criteria
Inclusion
- Newborns with Spina Bifida (Postnatal Closure)
- Diagnosed with open spina bifida (myelomeningocele).
- Scheduled for postnatal surgical closure of the spinal lesion at Great Ormond Street Hospital (GOSH).
- Age: Between 1 day to 1 year old.
- Control Group 1 (Newborns with Hydrocephalus)
- Newborns scheduled for shunt surgery for hydrocephalus unrelated to spina bifida.
- Age and sex matched to the spina bifida newborns as closely as possible.
- Age: Between 1 day to 1 year old.
- Control Group 2 (Infants with Spinal Conditions Unrelated to Spina Bifida)
- Infants undergoing paned spinal surgery for conditions such as spinal lipoma, fatty filum, tethered cord, etc.
- Age and sex matched to the spina bifida newborns as closely as possible.
- Age: Between 1 day to 1 year old. Fetuses with Spina Bifida (Prenatal Closure)
- Prenatal diagnosis of spina bifida (myelomeningocele) and scheduled for fetal surgery at UCLH.
- Reviewed by Mr Thompson at his outpatient clinic at GOSH
- Gestational age: Between 22 and 24 weeks.
- Control Fetal Samples
- Aborted fetuses within the gestational age range of 22-24 weeks.
- Samples obtained through the Human Developmental Biology Resource (HDBR).
- Mouse Models
- Genetic mouse model of spina bifida (Cdx2Cre x Pax3flox).
- At embryonic day (E)13.5 (end of the embryonic period) and E18.5 (just before birth)
- Control Mouse Models
- Normal (wild-type) mice to serve as controls.
- Normal brain development
- At embryonic day (E)13.5 (end of the embryonic period) and E18.5 (just before birth)
Exclusion
- Newborns with Spina Bifida (Postnatal Closure)
- Newborns who have undergone previous surgical intervention.
- Presence of additional unrelated congenital anomalies that could affect cerebrospinal fluid (CSF) composition like meningitis or intraventricular bleeding
- Older than 1 year and 1 month of age.
- Parents refused to participate
- Native language different to English with no translation services available
- Control Group 1 (Newborns with Hydrocephalus)
- Newborns with hydrocephalus caused by spina bifida.
- Presence of intraventricular infection or haemorrhage.
- Older than 1 year and 1 month of age.
- Parents refused to participate
- Native language different to English with no translation services available
- Control Group 2 (Infants with Spinal Conditions Unrelated to Spina Bifida)
- Infants who were born with spina bifida
- Infants with coexisting conditions that could affect CSF composition like intraspinal tumours, empyema or haemorrhage.
- Older than 1 year and 1 month of age.
- Parents refused to participate
- Native language different to English with no translation services available
- Fetuses with Spina Bifida (Prenatal Closure)
- Fetuses with additional major anomalies unrelated to spina bifida like diaphragmatic hernia.
- Gestational age outside the range of 22-24 weeks.
- Surgery performed by other neurosurgery team (not GOSH)
- Parents refused to participate
- Native language different to English with no translation services available
- Control Fetal Samples
- Poorly preserved aborted fetuses not suitable for CSF collection.
- Gestational age outside the range 22-24 weeks.
- Mouse Models
- Mice with any genetic modifications other than those specified for the spina bifida model.
- Mice with other congenital or acquired anomalies affecting the central nervous system.
- Control Mouse Models
- ● Mice with any genetic modifications or health conditions that could influence the study's outcomes.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06560788
Start Date
September 1 2024
End Date
August 1 2027
Last Update
August 21 2024
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