Clinical trial NCT06108778: Incidence of Metabolic Disorders in Neonatal Convulsions
Official title: Adescriptive Study on Incidence of Metabolic Disorders in Neonatal Convulsions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neonatal Convulsions
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 115
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates with convulsions due to metabolic diseases

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Describe incidence of metabolic disorders in neonatal convulsions affecting neonates at NICU
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
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.
citation: 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.