Neonatal Hypothermia Clinical Trial
Official title:
Pilot Clinical Assessment of Low-cost Infant Incubator in Monitoring Temperature and Treating Hypothermia in Infants
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will continue at the clinician's discretion until the infant can be weaned from the incubator or until patients are withdrawn from the study and placed on the standard of care.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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 28 Days |
Eligibility | Inclusion Criteria: - The subject is currently being treated at QECH in the neonatal ward. - An IncuBaby device and study monitor are available for use. - The subject's caregiver has provided informed consent for their child to participate (consent form attached to this proposal). - Phase II only: the subject is eligible for thermal care in an incubator. If the subject is recommended for KMC, they will not be eligible for participation in this study. To be considered for care with the IncuBaby, infants should be: - Less than 1000 g - Or > 1000 g but - Receiving medical interventions such as CPAP, oxygen, phototherapy, or IV - Unstable, critically ill or surgical conditions - No mother or caregiver available for KMC - Mother too sick to provide KMC - Clinician in charge has decided against KMC as requires closer supervision by nursing staff - No space in KMC Exclusion Criteria: The subject may be excluded from the study at the clinician's discretion for any reason including potential for skin irritation, cough or other condition that may preclude use of the temperature belt, or concurrent treatments that may require increased patient care. Only subjects eligible for care in an incubator will be enrolled in phase II. |
Country | Name | City | State |
---|---|---|---|
Malawi | Queen Elizabeth Central Hospital | Blantyre |
Lead Sponsor | Collaborator |
---|---|
William Marsh Rice University | University of Malawi College of Medicine |
Malawi,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Temperature monitor accuracy | Continuously measured temperature for temperature monitor compared against Philips Intellivue patient monitor | from time of enrollment until intervention is complete; up to 28 days | |
Primary | Temperature of incubator | Continuously measured temperature of incubator | from time of enrollment until intervention is complete; up to 28 days | |
Primary | Temperature of infant | Continuously measured temperature of infant | from time of enrollment until intervention is complete; up to 28 days | |
Secondary | Time until normothermia | Time until infant becomes normothermic (36.5-37.5C) | from time of enrollment until intervention is complete; up to 28 days | |
Secondary | Proportion of time normothermic | The proportion of treatment time that the infant is normothermic (36.5-37.5C) | from time of enrollment until intervention is complete; up to 28 days |
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