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Evaluation of Pediatric Critical Illness Neuropathy/Myopathy in Pediatric Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT02763709
Recruitment Status : Unknown
Verified May 2016 by Ananthanarayanan, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
First Posted : May 5, 2016
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Ananthanarayanan, Postgraduate Institute of Medical Education and Research

Brief Summary:
Intensive Care Unit Acquired Weakness(ICUAW) encompasses a spectrum of disorders characterized by generalized weakness developing after the onset of critical illness. Pediatric data on the incidence of ICUAW is restricted to isolated case reports and case series of no more than five children. Critical illness polyneuropathy is characterized by reduction in compound motor action potential or sensory nerve action potential or both with preserved conduction velocity on electrophysiological studies. These findings can occur very early prior to the onset of clinical features. Given the dearth of data in children on the subject, this study has been planned to evaluate the incidence of critical illness associated polyneuropathy /myopathy in severely sick children admitted.

Condition or disease
Critical Illness Polyneuropathy

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 97 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Pediatric Critical Illness Neuropathy/Myopathy in Pediatric Intensive Care Unit
Study Start Date : March 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Disorders

Group/Cohort
Cases
Children admitted in Pediatric ICU for more than 24 hours with Pediatric Risk of Mortality (PRISM) score III > 20



Primary Outcome Measures :
  1. Incidence of Pediatric critical illness polyneuropathy/myopathy [ Time Frame: 1 month ]


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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children admitted in Pediatric Intensive Care Unit for more than 24 hours with a Pediatric Risk of Mortality (PRISM) score III > 20
Criteria

Inclusion Criteria:

  • Children admitted in Pediatric Intensive Care Unit for more than 24 hours
  • Pediatric Risk of Mortality (PRISM) score III > 20

Exclusion Criteria:

  • Previous (Eg: Diabetes Mellitus, Systemic Lupus Erythematosus, Dermatomyositis, Spinal Muscular Atrophy) or current neuromuscular disorder (e.g Guillian Barre Syndrome, snake bite, myositis)
  • Use of drugs causing neuromuscular blockade
  • Bilateral Lower limb disorders precluding Nerve Conduction Study or ElectroMyoGraphy (Gross edema, fractures, amputation, plaster casts, open wounds, infections)
  • Children with abnormal electrophysiological studies at baseline examination will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763709


Contacts
Contact: Ananthanarayanan K, MD 09814393609 cerebratelife@gmail.com

Locations
India
PGIMER Recruiting
Chandigarh, India, 160012
Contact: Naveen Sankhyan, MD DM       drnsankhyan@yahoo.co.in   
Contact: Pratibha Singhi, MD       doctorpratibhasinghi@gmail.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Naveen Sankhyan, DM Postgraduate Institute of Medical Education and Research
Principal Investigator: Pratibha Singhi, MD Postgraduate Institute of Medical Education and Research

Responsible Party: Ananthanarayanan, Senior resident, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02763709     History of Changes
Other Study ID Numbers: PEDCIMP2016
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Critical Illness
Polyneuropathies
Disease Attributes
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases