Incidence of Metabolic Disorders in Neonatal Convulsions

Neonatal Convulsions Clinical Trial

Official title:

Adescriptive Study on Incidence of Metabolic Disorders in Neonatal Convulsions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06108778
• Other study ID #: Neonatal convulsions
• Status: Not yet recruiting
• Start date: November 25, 2023
• Est. completion date: February 25, 2025

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Amira Mohamed Sayed, master
• Phone: 01140282846
• Email: amiramohamed12yahoo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 115
• Est. completion date: February 25, 2025
• Est. primary completion date: December 25, 2024
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Diseases
• Neonatal Convulsions
• Seizures

Intervention

Device:
• MRI
Investigations as CT,MRI.serum ammonia and lactate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Balakrishnan 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. — View Citation

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. — View Citation

Stomnaroska 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe incidence of metabolic disorders in neonatal convulsions affecting neonates at NICU	Describe types of metabolic disorders causing neonatal convulsions	Baseline