Pilot Clinical Assessment of Low-cost Infant Incubator in Monitoring Temperature and Treating Hypothermia in Infants
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|ClinicalTrials.gov Identifier: NCT03965312|
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : September 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Hypothermia||Device: Continuous temperature monitor Device: Neonatal Incubator Device: Patient monitor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
In the first phase of the study, a novel neonatal temperature monitor and a commercially available patient monitor (Philips Intellivue MP30) will be applied to the same infant; results between them will be compared.
In the second phase of the study, infants at risk for hypothermia will be placed in an infant incubator; the accuracy of the temperature sensor, time required for infant to become normothermic, and the proportion of time that the infant remains normothermic will be measured.
|Masking:||None (Open Label)|
|Official Title:||Pilot Clinical Assessment of Low-cost Infant Incubator in Monitoring Temperature and Treating Hypothermia in Infants|
|Actual Study Start Date :||July 31, 2017|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: Temperature monitoring (1) and incubator test (2) groups
In the first (1) phase of the study, the temperature probe and monitor will be attached to infants along with the Philips Intellivue patient monitor. Temperature will be monitored continuously for up to 72 hours.
In the second (2) phase of this study, infants at risk for hypothermia and not eligible for skin-to-skin care will be placed in the incubator.
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.
Other Name: IncuBaby
Device: Patient monitor
Temperature will be measured using a commercially available patient monitor.
Other Name: Philips Intellivue patient monitor
- Temperature monitor accuracy [ Time Frame: from time of enrollment until intervention is complete; up to 28 days ]Continuously measured temperature for temperature monitor compared against Philips Intellivue patient monitor
- Temperature of incubator [ Time Frame: from time of enrollment until intervention is complete; up to 28 days ]Continuously measured temperature of incubator
- Temperature of infant [ Time Frame: from time of enrollment until intervention is complete; up to 28 days ]Continuously measured temperature of infant
- Time until normothermia [ Time Frame: from time of enrollment until intervention is complete; up to 28 days ]Time until infant becomes normothermic (36.5-37.5C)
- Proportion of time normothermic [ Time Frame: from time of enrollment until intervention is complete; up to 28 days ]The proportion of treatment time that the infant is normothermic (36.5-37.5C)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965312
|Contact: Rebecca Elias, MPHfirstname.lastname@example.org|
|Principal Investigator:||Rebecca Richards-Kortum, PhD||William Marsh Rice University|
|Principal Investigator:||Queen Dube, MD||University of Malawi College of Medicine|