Study of Clinical Features of Patients with Tuberculosis admitted in a Pediatric Intensive Care Unit.

Not Applicable

• Conditions: Health Condition 1: A159- Respiratory tuberculosis unspecifiedHealth Condition 2: A179- Tuberculosis of nervous system, unspecifiedHealth Condition 3: A188- Tuberculosis of other specified organs

• Registration Number: CTRI/2023/02/050046
• Lead Sponsor: o Sponsor MD Dissertation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.All children aged 1month -12 years admitted to the PICU, diagnosed as Tuberculosis (TB) bacteriologically and clinically as per case definitions by the World health Organization (WHO).

2.Clinical diagnosis of TB meningitis will be as per the Doerr et al.9 classification.

3.Every readmission after discharge from the hospital (and the subsequent outcome&complications) will be considered as a separate event/ separate case enrolled.

Exclusion Criteria

Patients for whom the parents/guardians are not willing to give informed consent for participation. This is applicable only for the participants enrolled prospectively.Waiver of consent and assent will be requested for the retrospectively enrolled cases, as there will be no patient contact for these patients and all the data will be extracted from the indoor case sheets/ records only.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Frequency of category/ type of patients with Tuberculosis (pulmonary and extrapulmonary Tuberculosis- neurotuberculosis, abdominal TB, musculoskeletal TB, genitourinary TB, disseminated TB, TB lymphadenitis, others-cutaneous TB,TB laryngitis etc). <br/ ><br>2. Percentage of primary system affected and the need for PICU admission. <br/ ><br>Timepoint: At discharge from the Pediatric intensive care <br/ ><br>unit or at death of the patient.

Secondary Outcome Measures

Name	Time	Method
1. Survival or death, cause of death, morbidity and sequelae at discharge. <br/ ><br>2. Frequency of complications affecting each system and adverse effect of treatment. <br/ ><br>3. Percentage of drug resistance pattern.Timepoint: At discharge from the Pediatric intensive care <br/ ><br>unit or at death of the patient.