Pilot Clinical Assessment of Low-cost Infant Incubator in Monitoring Temperature and Treating Hypothermia in Infants

Summary

A team of researchers at Rice University and Queen Elizabeth Central Hospital (QECH) are working to develop a low-cost infant incubator called "IncuBaby" that consists of two components: a temperature sensor that can continuously monitor an infant's temperature, and a heated, enclosed area that can adjust internal temperature based on the feedback from the temperature sensor. This robust, low-cost device will allow for the individualized treatment of hypothermia with minimal intervention from the clinical staff. In this study, researchers intend to evaluate the efficacy of this incubator at QECH by comparing infants' temperatures before and after treatment, and calculating the proportion of time that the infants remain in a normothermic range after rewarming. During phase I of this study, the infants will be continuously monitored using the IncuBaby temperature sensor and a gold standard temperature monitor for up to 3 days. The accuracy of the IncuBaby temperature sensor will be determined by calculating the difference between the temperatures recorded by the temperature sensor and the commercial patient monitor at each point in time. During phase II of the study, infants in need of thermal care with an incubator will be treated with an IncuBaby device and their temperatures will be continuously monitored by both the temperature sensor of the IncuBaby device and a commercially available patient monitor. Care will continue at the clinician's discretion until the infant can be weaned from the incubator or until patients are withdrawn from the study and placed on the standard of care. To determine the effectiveness of the IncuBaby device at warming infants, the temperatures of the infants will be compared before and after treatment for each subject. The proportion of time the device maintains the subject's temperature in a normal range will also be calculated.

Conditions

• Neonatal Hypothermia

Interventions

DEVICE

Continuous temperature monitor

Temperature will be measured using a novel temperature monitor continuously for up to 72 hours. Accuracy (as compared to a commercially available patient monitor) will be evaluated.

DEVICE

Neonatal Incubator

Infants at risk for hypothermia will be placed in a neonatal incubator. Their temperature will be monitored as they are treated. The infant will be treated until the infant is transitioned to skin-to-skin care, discharged, or no longer at risk for hypothermia.

DEVICE

Patient monitor

Temperature will be measured using a commercially available patient monitor.

Sponsors & Collaborators

• Kamuzu University of Health Sciences

  collaborator OTHER

• William Marsh Rice University

  lead OTHER

Principal Investigators

• Rebecca Richards-Kortum, PhD · William Marsh Rice University

• Queen Dube, MD · Kamuzu University of Health Sciences

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

28 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-31

Primary Completion

2022-09-30

Completion

2022-09-30

Countries

• Malawi

Study Locations