Neonatal ConvulsionsNCT06108778
Incidence of Metabolic Disorders in Neonatal Convulsions
An observational study of Neonatal Convulsions, run by Assiut University.
Trial summary
Describe the incidence of metabolic disorders in neonatal convulsions affecting neonates at NICU Describe types of metabolic disorders causing neonatal convulsions Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Convulsions
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2023to 25 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Child
Study population: Neonates with convulsions due to metabolic diseases
Who may be able to join
- Neonatal convulsions associated with vomiting,acidotic breathing,DCL,change of body tone or change in hair color
- Abnormal metabolic investigations (elevated serum ammonia and lactate ,persistent metabolic acidosis,abnormal metabolic screening and hypoglycemia
- persistent neonatal convulsions not respond to antiepileptic drugs
Who cannot join
- History of neonatal asphyxia
- History of birth trauma
- Signs of sepsis and CNS infection
- Neonate with electrolyte disturbance
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Adescriptive Study on Incidence of Metabolic Disorders in Neonatal Convulsions
Describe the incidence of metabolic disorders in neonatal convulsions affecting neonates at NICU Describe types of metabolic disorders causing neonatal convulsions
Read the detailed description
Neonates are susceptible to seizures due to several physiologic factors and combination of risks that are uniquely associated with gestation, delivery,and the immediate postnatal period. Neonatal seizures can be challenging to identify therefore itis imperative that clinicians have ahigh degree of suspicion for seizures based on the clinical history or the presence of encephalopathy with or without paroxysmal abnormal movements. Acute symptomatic neonatal seizures are due to an acute brain injury, whereas neonatal onset_epilepsy may be due to underlying structural, metabolic ,or genetic disorders.Early identification and treatment are likely important for long term outcomes in acute symptomatic seizures though additional studies are needed to understand optimal seizure control metrics and the ideal duration of treatment. seizures may be the first and the major presenting feature of an inborn error of metabolism. seizures may be preceded by other major symptoms by areduced level of consciousness in achild with an organic acidemia or urea cycle defect or by loss of skills ,progressive weakness ,ataxia ,and upper motor signs in achild with lysosomal storage disorder or peroxisomal leukodystrophy.the metabolic causes of seizure vary according to age at presentation.
- Conditions
- Neonatal Convulsions
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Investigations as CT,MRI.serum ammonia and lactate
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe incidence of metabolic disorders in neonatal convulsions affecting neonates at NICU
Describe types of metabolic disorders causing neonatal convulsions
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start25 Nov 2023 (estimated)
- Primary completion25 Dec 2024 (estimated)
- Study completion25 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal ConvulsionsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohamed Sayed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108778
- Sponsor's protocol ID
- Neonatal convulsions
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Russ JB, Simmons R, Glass HC. Neonatal Encephalopathy: Beyond Hypoxic-Ischemic Encephalopathy. Neoreviews. 2021 Mar;22(3):e148-e162. doi: 10.1542/neo.22-3-e148.
PubMed 33649088Stomnaroska O, Petkovska E, Jancevska S, Danilovski D. Neonatal Hypoglycemia: Risk Factors and Outcomes. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2017 Mar 1;38(1):97-101. doi: 10.1515/prilozi-2017-0013.
PubMed 28593892Balakrishnan U, Chandrasekaran A, Amboiram P, Ninan B, Ignatious S. Outcome of Inherited Metabolic Disorders Presenting in the Neonatal Period. Indian J Pediatr. 2021 May;88(5):455-462. doi: 10.1007/s12098-020-03522-6. Epub 2020 Oct 14.
PubMed 33051787
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adescriptive Study on Incidence of Metabolic Disorders in Neonatal Convulsions
- ClinicalTrials.gov ID
- NCT06108778
- Acronym / sponsor ID
- Neonatal convulsions
- Conditions
- Neonatal Convulsions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Nov 2023 (estimated)
- Primary completion
- 25 Dec 2024 (estimated)
- Study completion
- 25 Feb 2025 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Describe the incidence of metabolic disorders in neonatal convulsions affecting neonates at NICU Describe types of metabolic disorders causing neonatal convulsions
Detailed description
Neonates are susceptible to seizures due to several physiologic factors and combination of risks that are uniquely associated with gestation, delivery,and the immediate postnatal period. Neonatal seizures can be challenging to identify therefore itis imperative that clinicians have ahigh degree of suspicion for seizures based on the clinical history or the presence of encephalopathy with or without paroxysmal abnormal movements. Acute symptomatic neonatal seizures are due to an acute brain injury, whereas neonatal onset_epilepsy may be due to underlying structural, metabolic ,or genetic disorders.Early identification and treatment are likely important for long term outcomes in acute symptomatic seizures though additional studies are needed to understand optimal seizure control metrics and the ideal duration of treatment. seizures may be the first and the major presenting feature of an inborn error of metabolism. seizures may be preceded by other major symptoms by areduced level of consciousness in achild with an organic acidemia or urea cycle defect or by loss of skills ,progressive weakness ,ataxia ,and upper motor signs in achild with lysosomal storage disorder or peroxisomal leukodystrophy.the metabolic causes of seizure vary according to age at presentation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- Neonates with convulsions due to metabolic diseases
Key inclusion criteria (3 listed)
- Neonatal convulsions associated with vomiting,acidotic breathing,DCL,change of body tone or change in hair color
- Abnormal metabolic investigations (elevated serum ammonia and lactate ,persistent metabolic acidosis,abnormal metabolic screening and hypoglycemia
- persistent neonatal convulsions not respond to antiepileptic drugs
Key exclusion criteria (4 listed)
- History of neonatal asphyxia
- History of birth trauma
- Signs of sepsis and CNS infection
- Neonate with electrolyte disturbance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIInvestigations as CT,MRI.serum ammonia and lactate | Device | – |
Primary outcome
Describe incidence of metabolic disorders in neonatal convulsions affecting neonates at NICU
Time frame: Baseline
Describe types of metabolic disorders causing neonatal convulsions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 33649088Russ JB, Simmons R, Glass HC. Neonatal Encephalopathy: Beyond Hypoxic-Ischemic Encephalopathy. Neoreviews. 2021 Mar;22(3):e148-e162. doi: 10.1542/neo.22-3-e148.
- Background: PubMed 28593892Stomnaroska O, Petkovska E, Jancevska S, Danilovski D. Neonatal Hypoglycemia: Risk Factors and Outcomes. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2017 Mar 1;38(1):97-101. doi: 10.1515/prilozi-2017-0013.
- Background: PubMed 33051787Balakrishnan U, Chandrasekaran A, Amboiram P, Ninan B, Ignatious S. Outcome of Inherited Metabolic Disorders Presenting in the Neonatal Period. Indian J Pediatr. 2021 May;88(5):455-462. doi: 10.1007/s12098-020-03522-6. Epub 2020 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Convulsions, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Mohamed Sayed, master (01140282846, amiramohamed12yahoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe incidence of metabolic disorders in neonatal convulsions affecting neonates at NICU (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06108778, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.