The Role of CSF in Chiari II Brain Malformation
Launched by UNIVERSITY COLLEGE, LONDON · Aug 15, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking into how cerebrospinal fluid (CSF) might affect brain development in babies with a serious condition called spina bifida, specifically the type known as myelomeningocele. Spina bifida can lead to other complications, including Chiari II malformation, which involves parts of the brain being pushed down into the spine. Researchers believe that the CSF in these babies might not be normal due to a leak from the spine, and this could impact brain development in important ways. By studying CSF from various groups of newborns and even using mouse models, the trial aims to understand how this fluid might contribute to brain issues in spina bifida.
To be eligible for the study, newborns must be diagnosed with open spina bifida and scheduled for surgery to close the spinal defect, or they must have hydrocephalus (fluid buildup in the brain) for reasons not related to spina bifida. The study will also include infants with other spinal conditions and some fetal cases. Participants can expect to provide CSF samples during their medical care, and the findings may help improve understanding and treatment of brain problems related to spina bifida in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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.
About University College, London
University College London (UCL) is a leading global research institution renowned for its commitment to advancing healthcare through innovative clinical trials. As a prominent sponsor of clinical research, UCL leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous investigations aimed at improving patient outcomes and addressing pressing medical challenges. The institution fosters collaboration among researchers, healthcare professionals, and industry partners, ensuring that its trials adhere to the highest ethical standards and regulatory guidelines. UCL's dedication to translating scientific discoveries into practical applications underscores its role as a vital contributor to the advancement of medical science and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported