NCT06108778

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

November 25, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2025

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

October 25, 2023

Last Update Submit

November 6, 2023

Conditions

Neonatal Convulsions

Outcome Measures

Primary Outcomes (1)

  • Describe incidence of metabolic disorders in neonatal convulsions affecting neonates at NICU

    Describe types of metabolic disorders causing neonatal convulsions

    Baseline

Interventions

MRIDEVICE

Investigations as CT,MRI.serum ammonia and lactate

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates with convulsions due to metabolic diseases

You may qualify if:

  • 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

You may not qualify if:

  • History of neonatal asphyxia
  • History of birth trauma
  • Signs of sepsis and CNS infection
  • Neonate with electrolyte disturbance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 33649088BACKGROUND

  • 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.

    PMID: 28593892BACKGROUND

  • 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.

    PMID: 33051787BACKGROUND

Central Study Contacts

Amira Mohamed Sayed, master

CONTACT

01140282846amiramohamed12yahoo@gmail.com

Abdellatif Mohamed Abdelmoaz, professor

CONTACT

01005208016a.m.abdelmoez@aun.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

November 25, 2023

Primary Completion

December 25, 2024

Study Completion

February 25, 2025

Last Updated

November 7, 2023

Record last verified: 2023-11