Incidence of Metabolic Disorders in Neonatal Convulsions

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06108778
Collaborator
(none)
115
15

Study Details

Study Description

Brief Summary

Describe the incidence of metabolic disorders in neonatal convulsions affecting neonates at NICU Describe types of metabolic disorders causing neonatal convulsions

Condition or Disease Intervention/Treatment Phase
  • Device: MRI

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

Study Type:
Observational
Anticipated Enrollment :
115 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Adescriptive Study on Incidence of Metabolic Disorders in Neonatal Convulsions
Anticipated Study Start Date :
Nov 25, 2023
Anticipated Primary Completion Date :
Dec 25, 2024
Anticipated Study Completion Date :
Feb 25, 2025

Outcome Measures

Primary Outcome Measures

  1. Describe incidence of metabolic disorders in neonatal convulsions affecting neonates at NICU [Baseline]

    Describe types of metabolic disorders causing neonatal convulsions

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 28 Days
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • History of neonatal asphyxia

  • History of birth trauma

  • Signs of sepsis and CNS infection

  • Neonate with electrolyte disturbance

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Amira Mohamed Sayed Ahmed, Assistant lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT06108778
Other Study ID Numbers:
  • Neonatal convulsions
First Posted:
Oct 31, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023