A study to determine the causes and prevalence of critical illness amongst children presenting to participating hospitals in resource-limited settings
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2021/12/038425
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
**Background:**
Greater than 90% of the global 6.4 million deaths inchildren under 14 years occur in resource-limited settings. Acute pediatriccritical illnesses – sepsis, pneumonia, trauma – are leading causes of deathand disability outside of the neonatal period, yet critical care services arenot universally available(1-4). A significant number ofthese lives could be saved byproven, simple critical care and supportive interventions(5-7) despite challenging environments and fewer pediatricavailable critical care resources as compared to high-income countries(8). However, there is a gross disparity not only inavailable pediatric critical care resources, but also of available data, and,thus, evidenced-based guidelines, between high income counties (HIC’s) and lowand middle income countries (LMIC’s)(9). Without region-specific data that captures theburden of disease, outcomes, and resource utilization of pediatric populationsin resource-limited settings, we cannot develop context-appropriate,evidence-based interventions, or appropriately allocate limited but availableresources to hospitals. Even accepted practices such as aggressive fluidresuscitation for patients in septic shock, which is standard of care in HIC’s,can lead to increased mortality compared to controls in LMIC’s(10).
***We propose to undertake a prospective,*** ***observational,*** ***multicenter, multinational point prevalence study tomeasure the burden of acute pediatric critical illness in LMIC’s.***
Our proposed project is a crucial first step insetting future research and health delivery priorities for LMIC’s.
**SpecificAim 1:** Determine the etiology and prevalence of pediatric acutecritical illness amongst children presenting to participating hospitals inresource-limited settings.
**Specific Aim 2:** Measure hospital outcomes (hospital mortality, lengthof stay) in children with acute critical illness in resource-limited settings.
**Specific Aim 3:** Determine hospital resource utilization by childrenwith acute critical illness
**Specific Aim 4**: Determine the current resources available to provideacute critical care across LMIC’s.
**Study Design**. We will leverage the PediatricAcute Lung Injury and Sepsis Investigators’ (PALISI) Research network torecruit hospitals in LMIC’s in Central and Latin America, Africa, and SouthAsia. Sites will include hospitals in Mali, Malawi, Tanzania,Kenya, Pakistan and Peru *and* othersas enrolled. All sites will be askedto fill out a survey assessing the aboveaspects of resource availability, the presence of a basic researchinfrastructure including ethical and/or IRB approval mechanisms, and theavailability of a local site PI. The study population is acutely ill orinjured children (aged 28 days to 14 years) presenting to an ED or directlyadmitted to an inpatient unit at a participating hospital.
***Inclusion criteria*** **include:**
1. Children (aged 28 days to 14 years)
2. Children evaluated in the ED for an acute illnessor injury or admitted to an inpatient unit at a participating study site, whoare discharged home after ED evaluation, who died in the ED or are transferredto a higher level of care.
***Exclusion criteria*** **include:** Children presenting for a follow-up visit,vaccinations, suture removal (or other non-acute complaint) or children with acorrected gestational age less than 42 weeks.
All pediatric patients will be screened uponpresentation to the emergency department (ED), or equivalent acute hospitalreceiving unit, over a 24-hour time period on a given day, and childrenadmitted to the hospital, even if boarded in the ED, will be followed foroutcomes. Patients admitted to the hospital (general pediatric ward, high-dependencyunit [HDU], or intensive care unit [ICU]) will be followed daily to determineresource utilization in the 24 hours preceding the time of discharge or deathto determine in-hospital outcomes. Participants will receive routine standardof care per local standards and resource availability.
**The primary outcome** is prevalence of acute critical illness, defined asdeath within 48 hours of presentation to the hospital, including ED mortality;OR admission/transfer to an HDU or ICU; OR transfer to another institution witha higher level of care; OR receiving critical care-level interventions (vasopressor infusion, invasive mechanicalventilation, non-invasive mechanical ventilation) regardless of location in thehospital.
**Secondary outcomes include:** etiology of critical illness, in-hospital mortality,early mortality (death within 48 hours of presentation), cause of death,resource utilization, and change in neurocognitive status from premorbid statefrom admission to discharge(Pediatric Overall Performance Category [POPC] and Pediatric CerebralPerformance Category [PCPC]).
A member of the research team will screen the medicalrecords of all children presenting to the ED or direct admits to inpatientunits for inclusion criteria. Once included, study personnel will then followparticipating patients prospectively to determine in-hospital outcomes andresource utilization by reviewing their medical records. The local researchteam will collect data from the medical chart on the day of admission and thenonce a day until death or discharge.
For Specific Aim 4, a seperate survey will be sent out to befilled by physicians working in different hospitals across the world tounderstand the resources available at these facilities (human resources, typesof beds, technologies, medication availability). This survey will not includeany patient information or identifiers.
***Datacollection*** **will include:**
1) patient characteristics; presenting symptoms;severity of illness; anthropometrics (weight, height, mid-upper armcircumference); comorbidities (HIV status, congenital heart disease,malnutrition); presenting vital signs; available laboratory test results;imaging results; and the POPC and PCPC prior to the current illness.
2)hospital resource utilization: We will collect data on use of bloodtransfusion, fluid bolus, vasoactive agents, non-invasive positive pressureventilation, oxygen, mechanical ventilation, ICU admission, and antibioticadministration.
3)outcomes: including discharge home, transfer to a higher level of care withinthe hospital, transfer to another hospital, and death; final hospitaldiagnosis, length of stay and documented cause of death (if applicable), andthe POPC and PCPC at the time of discharge.
4) Hospital Characteristics: including average numberof patient encounters and admissions, types of inpatient units, humanresources, infrastructure including healthcare devices, medications and laboratoryavailability
***DataAnalysis*****:** Data will be analyzed on all subjects who meet inclusion criteria. Once theselection period ends, we will conduct power calculations to assess the minimaldetectable differences at sufficient powers with a minimum of 80%. Once data iscollected we will use statistical software (R, STATA) to first conductunivariate descriptive analyses to summarize population-level information. Wewill test for an association between patient characteristics and outcomes withbivariate analyses. We will fit a mixed effects model to explore risk factorsassociated with critical illness (primary outcome), in-hospital mortality andearly mortality (secondary outcomes). The mixed effects will account forclustering (facility-level, region-level) time-varying variables, andtime-invariant variables. Variables will be chosen for inclusion in themultivariate models based on their empirical significance in the literature(age, sex, severity of illness, HIV status, anemia, malnutrition), and based ontheir significance at the bivariate level to account for cohort-specificvariation. The final model with the best fit will be evaluated throughgoodness-of-fit tests for nested models and Bayesian Information Criterion fornon-nested models.
***Duration of study:*** The study duration is overtwo years. This includes site recruitment, pilot testing of data collectiontool, IRB approval and data collection at four separate time points.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 50
- Inclusion criteria include: 1.
- Children (aged 28 days to 14 years) 2.
- Children evaluated in the ED for an acute illness or injury or admitted to an inpatient unit at a participating study site, who are discharged home after ED evaluation, who died in the ED or are transferred to a higher level of care.
Exclusion criteria include: Children presenting for a follow-up visit, vaccinations, suture removal (or other non-acute complaint) or children with a corrected gestational age less than 42 weeks.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of acute critical illness, defined as death within 48 hours of presentation to the hospital, including ED mortality; OR admission/transfer to an HDU or ICU; OR transfer to another institution with a higher level of care; OR receiving critical care-level interventions (vasopressor infusion, invasive mechanical ventilation, non-invasive mechanical ventilation) regardless of location in the hospital 48 hours of presentation
- Secondary Outcome Measures
Name Time Method Etiology of critical illness, in-hospital mortality, early mortality (death within 48 hours of presentation), cause of death, resource utilization, and change in neurocognitive status from premorbid state from admission to discharge (Pediatric Overall Performance Category [POPC] and Pediatric Cerebral Performance Category [PCPC]) 48 hours of presentation
Trial Locations
- Locations (1)
Tata Memorial Centre
🇮🇳Mumbai, MAHARASHTRA, India
Tata Memorial Centre🇮🇳Mumbai, MAHARASHTRA, IndiaDr Shilpushp BhosalePrincipal investigator9619310657shilbhosale@gmail.com