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

NCT03965312 | Unknown

• 1 other identifier: IncuBaby-NHSRC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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will continue at the clinician's discretion until the infant can be weaned from the incubator or until patients are withdrawn from the study and placed on the standard of care.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

Outcome Measures

Primary Outcomes (3)

• 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

• Temperature of incubator

  Continuously measured temperature of incubator

  from time of enrollment until intervention is complete; up to 28 days

• Temperature of infant

  Continuously measured temperature of infant

  from time of enrollment until intervention is complete; up to 28 days

Secondary Outcomes (2)

• Time until normothermia

  from time of enrollment until intervention is complete; up to 28 days

• Proportion of time normothermic

  from time of enrollment until intervention is complete; up to 28 days

Study Arms (1)

Temperature monitoring (1) and incubator test (2) groups

EXPERIMENTAL

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; Device: Neonatal Incubator; Device: Patient monitor

Interventions

Continuous temperature monitor DEVICE

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.

Also known as: IncuBaby temperature sensor and monitor, Neonatal temperature monitor

Temperature monitoring (1) and incubator test (2) groups

Neonatal Incubator DEVICE

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.

Also known as: IncuBaby

Temperature monitoring (1) and incubator test (2) groups

Patient monitor DEVICE

Temperature will be measured using a commercially available patient monitor.

Also known as: Philips Intellivue patient monitor

Temperature monitoring (1) and incubator test (2) groups

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• William Marsh Rice University: lead
• Kamuzu University of Health Sciences: collaborator

Study Sites (1)

Queen Elizabeth Central Hospital

Blantyre, Malawi

RECRUITING

Related Publications (1)

• Sosa Saenz SE, Hardy MK, Heenan M, Oden ZM, Richards-Kortum R, Dube Q, Kawaza K. Evaluation of a continuous neonatal temperature monitor for low-resource settings: a device feasibility pilot study. BMJ Paediatr Open. 2020 May 7;4(1):e000655. doi: 10.1136/bmjpo-2020-000655. eCollection 2020.

  PMID: 32426530 DERIVED

MeSH Terms

Interventions

Monitoring, Physiologic

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Rebecca Richards-Kortum, PhD

  William Marsh Rice University

  PRINCIPAL INVESTIGATOR

• Queen Dube, MD

  Kamuzu University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Elias, MPH

CONTACT

713-348-6574; rebecca.elias@rice.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: May 29, 2019
• Study Start: July 31, 2017
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)