NCT02124616

Brief Summary

Our aim is to establish multi-center national Egyptian database of information for inherited and acquired neuromuscular diseases in infants and children from 0 to 18 years of age.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 28, 2014

Status Verified

April 1, 2014

Enrollment Period

6 years

First QC Date

April 25, 2014

Last Update Submit

April 25, 2014

Conditions

Keywords

spinal muscular atrophyMuscular dystrophyMuscle diseasesmyasthenic syndromesPolyneuropathiesMyopathies

Outcome Measures

Primary Outcomes (1)

  • Functional motor ability

    Motor power in acquired acute neuromuscular diseases will be assessed at admission and morbidity and mortality at discharge from hospital. Functional motor ability will be performed every 3 months for children with inherited neuromuscular diseases.

    1 year

Secondary Outcomes (1)

  • Cardio-pulmonary function

    12 months

Study Arms (1)

Neuromuscular diseases

Prospective cohort of children with inherited or acquired neuromuscular diseases.

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All children from birth to 18 years of age with inherited or acquired neuromuscular diseases.

You may qualify if:

  • Weakness, hypotonia.
  • Nerve conduction study and electromyographic confirmation of lower motor neuron affection.

You may not qualify if:

  • Chromosomal diseases.
  • Malformations and deformations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University

Cairo, Abassia, 11381, Egypt

RECRUITING

Related Links

MeSH Terms

Conditions

Muscular Atrophy, SpinalMuscular DystrophiesLambert-Eaton Myasthenic SyndromePolyneuropathiesMuscular Diseases

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesNeuromuscular DiseasesMuscular Disorders, AtrophicMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyasthenia GravisParaneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNeuromuscular Junction DiseasesAutoimmune DiseasesImmune System DiseasesPeripheral Nervous System Diseases

Study Officials

  • Sahar MA Hassanein, MD, PhD

    Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University

    STUDY CHAIR

Central Study Contacts

Sahar MA Hassanein, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

April 25, 2014

First Posted

April 28, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2020

Study Completion

December 1, 2020

Last Updated

April 28, 2014

Record last verified: 2014-04

Locations