MedPath

An observational study to understand viral causes of childhood respiratory illnesses in India and build capacity for their prevention, control, and management

Not Applicable
Conditions
Health Condition 1: J22- Unspecified acute lower respiratory infection
Registration Number
CTRI/2024/07/070880
Lead Sponsor
Society For Applied Studies
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Live birth

2.Available for enrolment within 14 days of birth

3.Family planning to stay in the study area until 2 years after childbirth

4.Parental consent for participation of their child

Tier 2

1.Under-five children hospitalized for following respiratory infection symptoms, cough, shortness of breath with RR more than 60 for infant below 2 months, more than 50 for infants 2-12 months and more than 40 for children above 1 year, onset within the past 10 days

2.Contact at 90 days after discharge is feasible

3.Additional criteria for infants 0-6 months age, Apnoea, Sepsis, fever (more than equal to 37.5°C) or hypothermia (less than 35.5°C), shock (lethargy, fast breathing, cold skin, prolonged capillary refill, or fast weak pulse), seriously ill with no apparent cause

4.Parental consent for participation of their child

Exclusion Criteria

1.Twins or triplets

2.Documented birth weight under 1500 grams or weight under 1500 grams at enrolment

3.Gestational age less than 32 weeks

4.HIV positive or born to women with known HIV infection

For Tier 2:

1.Presenting complaints/diagnosis for hospitalization are non-respiratory

2.Respiratory infection is healthcare associated i.e. presenting complaints of cough or shortness of breath began 48 hours after admission.

3.Diagnosed case of HIV or primary immunodeficiency

4.Children receiving chemotherapy or immunomodulator therapy

5.Children with major congenital anomalies affecting the cardiovascular, neural and respiratory system

6. Others - as per investigator evaluation

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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