Incidence of Metabolic Disorders in Neonatal Convulsions

November 6, 2023 updated by: Amira Mohamed Sayed Ahmed, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Neonates with convulsions due to metabolic diseases

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe incidence of metabolic disorders in neonatal convulsions affecting neonates at NICU
Time Frame: Baseline
Describe types of metabolic disorders causing neonatal convulsions
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 25, 2023

Primary Completion (Estimated)

December 25, 2024

Study Completion (Estimated)

February 25, 2025

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neonatal convulsions

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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