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

NCT02763709 | Unknown

• 1 other identifier: PEDCIMP2016
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness Polyneuropathy

Outcome Measures

Primary Outcomes (1)

• Incidence of Pediatric critical illness polyneuropathy/myopathy

  1 month

Study Arms (1)

Cases

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

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, Chandigarh, 160012, India

RECRUITING

Related Publications (1)

• Kasinathan A, Sharawat IK, Singhi P, Jayashree M, Sahu JK, Sankhyan N. Intensive Care Unit-Acquired Weakness in Children: A Prospective Observational Study Using Simplified Serial Electrophysiological Testing (PEDCIMP Study). Neurocrit Care. 2021 Jun;34(3):927-934. doi: 10.1007/s12028-020-01123-x. Epub 2020 Oct 7.

  PMID: 33025545 DERIVED

MeSH Terms

Conditions

Polyneuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Naveen Sankhyan, DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Pratibha Singhi, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ananthanarayanan K, MD

CONTACT

09814393609; cerebratelife@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior resident

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 5, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 5, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)