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Feasibility of a Novel Neonatal Incubator for Low-resource Settings

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ClinicalTrials.gov Identifier: NCT03965312
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
University of Malawi College of Medicine
Information provided by (Responsible Party):
William Marsh Rice University

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will continue at the clinician's discretion until the infant can be weaned from the incubator or until patients are withdrawn from the study and placed on the standard of care.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

Condition or disease Intervention/treatment Phase
Neonatal Hypothermia Device: Continuous temperature monitor Device: Neonatal Incubator Device: Patient monitor Not Applicable

Detailed Description:

This is a two-phase, pilot prospective study to determine the effectiveness of a low-cost incubator in warming infants and regulating their temperatures.

During Phase I, the following steps will be taken:

A trained study nurse will assess the subject for clinical complications before attaching the temperature monitoring device.

  1. A trained study nurse or clinician will attach the temperature monitoring device to the infant. A trained research assistant from Rice University or from the Biomedical Engineering Department at Malawi Polytechnic will observe all procedures and will notify the nurse of any observed errors so they may be corrected. They will also be able to answer any technical questions from the nurse.
  2. The trained study nurse will attach the temperature probe from the commercial patient monitor as well as provide any other care needed.
  3. A research assistant will use a laptop to collect the electrical signals from both temperature monitors.
  4. Temperature monitoring will continue for up to 3 days. The research assistant may ask the nurse to remove and reapply the temperature monitor during this period.

Once Phase I is complete, Phase II will begin. During Phase II, the following steps will be taken:

A trained study nurse will assess the subject for clinical complications before beginning treatment.

  1. A trained study nurse or research technician will turn the incubator on to begin pre-warming.
  2. A trained study nurse or clinician will attach the temperature probe from the IncuBaby device to the infant and then place the infant in the incubator. A trained research assistant from Rice University or from the Biomedical Engineering Department at Malawi Polytechnic will observe all procedures and will notify the nurse of any observed errors so they may be corrected. They will also be able to answer any technical questions from the nurse.
  3. The trained study nurse will attach the temperature probe from the commercial patient monitor as well as provide any other care needed.
  4. A research assistant will use a laptop to collect the data from both devices.
  5. Care will be continued at the discretion of the clinician until the infant can be weaned from the IncuBaby device. The infant may be weaned to the standard of care or end thermal treatment. The infant will be transitioned to Kangaroo Mother Care (KMC) as soon as possible after these eligibility criteria are fulfilled:

    • Completed other treatment (CPAP, phototherapy, IV)
    • Mom/caregiver becomes available
    • Weight increases > 1000g
    • Become clinically stable
    • Body temperature is stable and not dipping below normal despite thermal support

During both phases, a research assistant will be available during the trial to mitigate any complications with the device. A nurse will be available to respond to alarms from the continuous patient monitor. If the subject's guardian, the nurse, or the research assistant indicates concern during the tests, the study treatment can be discontinued and the subject will return to the standard of care.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
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)
Primary Purpose: Treatment
Official Title: Feasibility of a Novel Neonatal Incubator for Low-resource Settings
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: Temperature monitoring group
The temperature probe and monitor will be attached to the infant along with the Philips Intellivue patient monitor. Temperature will be monitored continuously for up to 72 hours.
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.
Other Names:
  • IncuBaby temperature sensor and monitor
  • Neonatal temperature monitor

Device: Patient monitor
Temperature will be measured using a commercially available patient monitor.
Other Name: Philips Intellivue patient monitor

Experimental: Incubator test group
An infant 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.
Other Names:
  • IncuBaby temperature sensor and monitor
  • Neonatal temperature monitor

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




Primary Outcome Measures :
  1. 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

  2. Temperature of incubator [ Time Frame: from time of enrollment until intervention is complete; up to 28 days ]
    Continuously measured temperature of incubator

  3. Temperature of infant [ Time Frame: from time of enrollment until intervention is complete; up to 28 days ]
    Continuously measured temperature of infant


Secondary Outcome Measures :
  1. 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)

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Contacts
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Contact: Paty Figueroa 713-348-4963 paty.figueroa@rice.edu

Locations
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Malawi
Queen Elizabeth Central Hospital Recruiting
Blantyre, Malawi
Contact: Rebecca R Richards-Kortum, PhD    7133483823    rkortum@rice.edu   
Contact: Queen Dube, MD       drdubefirst@yahoo.com   
Sponsors and Collaborators
William Marsh Rice University
University of Malawi College of Medicine
Investigators
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Principal Investigator: Rebecca Richards-Kortum, PhD William Marsh Rice University
Principal Investigator: Queen Dube, MD University of Malawi College of Medicine
  Study Documents (Full-Text)

Documents provided by William Marsh Rice University:
Informed Consent Form  [PDF] June 27, 2017


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Responsible Party: William Marsh Rice University
ClinicalTrials.gov Identifier: NCT03965312     History of Changes
Other Study ID Numbers: IncuBaby-NHSRC
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms