The aims & objectives of this study are

In the patients admitted to the Pediatric intensive care unit (PICU) 

1.     To study the frequency of acute undifferentiated febrile illness (AUFI).

2.     To study the etiology of AUFI.

3.     To study the clinical profile of AUFI.

4.     To study the complications in patients with AUFI.

5.     To study the outcome (survival/ death) in patients with AUFI.

MATERIALS & METHODS:

Study site

The study will be conducted in patients admitted to the PICU of KEM hospital, Mumbai, which is a tertiary care, 14-bedded PICU with state-of-art facilities including mechanical ventilators, non-invasive monitors and other devices for delivering critical care. It is manned by at least 4 resident medical officers round the clock. One Professor looks after the day-to-day clinical and administrative matters of the PICU and is assisted by one Associate Professor and one Assistant Professor. Fellows (MUHS) and senior registrars are also posted in the PICU (when available).

Type of study

The study will be a single center, observational, non-interventional, prospective study of consecutive patients admitted to the PICU.

Study period

The study will be conducted over 18 months (prospectively) after approval from IEC or till the desired sample size is reached. Each patient will be in the study till his/ her stay in the PICU.

Ethics The study will be initiated after seeking approval from the Institutional Ethics Committee (IEC) of Seth G.S Medical College and K.E.M hospital. The study will be conducted in compliance with the Ethical Guidelines for Biomedical Research on Human Participants by the Indian Council of Medical Research (ICMR).

Consent & assent Case enrolment will be done after a written informed consent from the parent or guardian. Assent will be obtained from patients more than 7 years of age. Since patients in the PICU are critically ill, the assent will be procured from children aged 7 years and above once the clinical condition stabilizes and when they are in a position to give the assent.

Confidentiality The participant’s details will not be disclosed at any point of time.

Sample size calculation

All consecutive patients admitted to the PICU and satisfying the case definition will be enrolled over a period of one year. As per data from previous years approximately 100 patients are expected to be enrolled over one year out of the expected total PICU admissions of 300-350. This is a convenience sampling hence no formal sample size calculations have been done.

Inclusion criteria

All consecutive children with AUFI aged 1 month to upto 12 years admitted to the PICU will be enrolled.

Case Definition: An acute undifferentiated febrile illness AUFI is characterized by fever of less than 2 weeks duration, without organ specific symptoms at the onset of the illness.

Exclusion criteria

Following patients will be excluded from the study

 Patients with an identifiable focus of infection clinically at the onset of illness e.g. pneumonia, urinary tract infection, gastro-enteritis, meningitis, sinusitis/otitis media, etc.

Patients whose parent/ guardian refuse to give informed consent.

Study Procedure

All consecutive patients admitted to the PICU satisfying the inclusion criteria will be enrolled after obtaining informed consent from the parent/ guardian. Prospective data will be recorded from indoor case sheets or papers.

Data Recording Following data or information will be recorded in a pre designed case record form  CRF (from the patient’s hospital case sheets/indoor medical papers)

   Demographic details like name, age, sex, date of admission to the hospital and date of admission to the PICU.

      Clinical details The following clinical details will be recorded-

1.     Indication for PICU admission,

2.     Chief complaints at the time of admission,

3.     Important or significant clinical examination findings,

4.     Course of illness in the PICU,

5.     Significant or diagnostic investigations,

6.     Complications (like respiratory failure, shock, acute kidney injury, MODS, need for oxygen therapy, non-invasive/ invasive mechanical ventilation, thrombocytopenia, sepsis, and nosocomial infections) will be noted. 

7.     Treatment given & response to treatment.

8.     Final complete diagnosis

 Outcome related data like Final outcome of the patient (survival or death), morbidity or sequelae at discharge, length of PICU stay and length of hospital stay will be noted.

The patient’s daily medical records will be scrutinized from admission until discharge/ death. All investigations done routinely in the PICU as a part of the treatment protocol will be recorded in the CRF. This study will not entail performing any new or additional investigations or new or additional treatment or any financial burden to the hospital or financial burden to the parent or guardian.

STATISTICAL ANALYSIS PLAN

The study shall be represented using descriptive analysis.

      Number of patients admitted with AUFI will be expressed as percentage of total patients admitted to the PICU during the study period.

       Age (months), Weight (kg), length of PICU stay and length of hospital stay will be expressed as mean +/-SD, median and mode.

      Clinical data (sex, etiology, clinical features, complications and outcomes) will be listed as percentage of total patients enrolled.

       Outcome in terms of mortality, and morbidity/ sequelae will be listed as percentage.

       Mortality will be correlated with age, sex, etiology, & complications using chi-square test.

EXPECTED OUTCOMES

Study of clinical spectrum will help to identify

·       Common causes of Acute Undifferentiated Febrile Illness AUFI in PICU.

·       Complications & outcome of the illnesses survival or death

This will aid in allocating appropriate resources for effective diagnostic and therapeutic interventions for AUFI, enabling the provision of optimal medical care to the patients in the future.

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