# Supplement to Development of a Mobile Health Personalized Physiologic Analytics Tool for Pediatric Patients with Sepsis

> **NIH NIH R33** · RHODE ISLAND HOSPITAL · 2024 · $175,814

## Abstract

Project Summary
Sepsis is the leading cause of child mortality worldwide, with most of these deaths occurring in low and middle-
income countries (LMICs). Novel digital technologies, including the use of mobile health tools (mHealth),
machine learning and artificial intelligence (ML/AI), wearables devices, and clinical decision support tools, hold
great promise for improving the care for children with sepsis in LMICs by overcoming human resource and
infrastructural barriers. However, digital health research among critically ill children in LMICs presents novel
ethical issues including concerns regarding understandability, data security, privacy, bias, and informed
consent. Additionally, ethical frameworks and policies regarding the use of these technologies (which are often
not cleared for medical use) are nearly non-existent in LMICs due to a lack of regulatory oversight and
governance specific for digital health research.
Critically ill children in LMICs are a special population who require careful consideration given their
vulnerability, reliance on caregivers for decision-making, and high variability in caregiver awareness and
exposure to digital technologies. Successful development of these novel technologies to improve patient health
relies on understanding the attitudes of key stakeholders, and barriers and facilitators to ethical
implementation, to ensure the use of best practices for facilitating trust and participation in research using
these technologies, while respecting patient/caregiver autonomy.
This project integrates new bioethical aims, research, and capacity building into an ongoing parent R33 study,
which has an objective to develop a novel wearable-linked mHealth tool deploying machine learning predictive
models for pediatric sepsis decision support in Bangladesh. This proposed research will examine and elucidate
the ethical concerns of caregivers of children with sepsis, as well as stakeholders in bioethical research
decision-making (clinicians, researchers, ethical review board members, administrators), related to research
using digital health technologies for clinical care among children with sepsis in LMICs. Knowledge gained from
this study will aid in developing an evidence base upon which to build policies, tools and approaches to aid in
the development and implementation of use of digital technologies for research in Bangladesh and other
similar LMIC settings. With guidance from a leading pediatric bioethics expert consultant, this collaborative
research between the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) and Rhode
Island Hospital / Brown University, will help augment icddr,b’s reputation in research ethics in South Asia, and
build a hub of bioethical research expertise on digital tools for studies conducted in LMICs.

## Key facts

- **NIH application ID:** 11064245
- **Project number:** 3R33TW012211-04S1
- **Recipient organization:** RHODE ISLAND HOSPITAL
- **Principal Investigator:** Stephanie Chow Garbern
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $175,814
- **Award type:** 3
- **Project period:** 2021-08-10 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11064245

## Citation

> US National Institutes of Health, RePORTER application 11064245, Supplement to Development of a Mobile Health Personalized Physiologic Analytics Tool for Pediatric Patients with Sepsis (3R33TW012211-04S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11064245. Licensed CC0.

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