Efficacy of Celsi Warmer for the Management of Hypothermic Newborns

August 18, 2023 updated by: William Marsh Rice University

Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns

The purpose of the study is to evaluate the efficacy of a novel low-cost warming device to provide thermal care for newborn babies with hypothermia in low-resource hospitals. During the study, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow us to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sonia Sosa Saenz, BME
  • Phone Number: 713-348-4963
  • Email: ss171@rice.edu

Study Contact Backup

Study Locations

  • Tanzania
      • Dar Es Salaam, Tanzania
        • Recruiting
        • Muhimbili University of Health and Allied Sciences (MUHAS)
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Rebecca R Richards-Kortum, PhD
        • Sub-Investigator:
          • Maria Oden, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is currently being treated at study location
  • Is an inborn admission to the neonatal ward
  • Whose parents or guardians provided a written informed consent
  • Whose parents or guardians providing informed consent are 18 years old or older
  • Has a current weight of greater than or equal to 1.0 kg and less than or equal to 4.0kg
  • Has been identified as in need of thermal care defined as having a moderate hypothermic temperature (32.0-36.0°C) as the last temperature recorded in hospital chart, or during recruitment procedures; and

  • Is unable to be enrolled in KMC for reasons including, but not limited to:

    1. Mother/guardian unable or unavailable to provide KMC
    2. Under observation in NICU before transfer to KMC
    3. No space in KMC
    4. Clinician's discretion
  • May be receiving other medical treatments, including but not limited to, CPAP, oxygen therapy, IV fluids, management and monitoring of common newborn conditions such as hypoglycemia, and/or hyperbilirubinemia via LED phototherapy

Exclusion Criteria:

  • Requires mechanical ventilation

  • deemed in need of intensive care by the hospital staff who is providing care,including but not limited to:

    1. Neonates with severe anemia and/or any suspected hematological disorders, and/or
    2. Neonates with obvious congenital anomalies, and/or
    3. neonates suspected with hypo/hyperthyroidism or any hormonal disorders
  • Has been diagnosed with birth asphyxia
  • Presents a condition that precludes the use of the temperature sensor and/or abdominal belt including but not limited to, gastroschisis, known umbilical cord infection, known skin infection
  • Whose clinician presents concerns about their participation
  • Is receiving treatment that participation in the study would interfere with, i.e.transferring to KMC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neonatal
  • A trained study nurse or clinician will transfer the enrolled participant to the study location and place the infant on the Celsi Warmer mattress.
  • A trained study nurse or clinician will attach the Celsi Warmer temperature sensor to the abdomen and secure it with the abdominal belt according to the device's instruction manual
  • A trained study nurse or clinician will wrap the baby according to the standard care at the hospital.
  • Study personnel may observe the participant during the intervention period and annotate timestamped events that might affect temperature measurement and/or thermoregulation support intervention.
  • Study personnel will perform routine abdominal skin assessments as often as every two hours and at least every 8 hours to observe for skin irritation or indentation.
  • Thermoregulation support intervention will be provided as long as the infant continues to meet criteria for continued care at clinician's discretion.
Device: Celsi Warmer
During the study, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow the research team to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns
Time Frame: 1 year
To evaluate the clinical efficacy and safety of the Celsi Warmer in rewarming hypothermic newborns by comparing the Celsi Warmer's accuracy in measuring neonatal temperature compared to the gold standard, axillary temperature readings.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of the Device
Time Frame: 1 year
To assess the performance of the Celsi Warmer in rewarming hypothermic newborns by measuring the incidence of attainment of normothermia (36.5-37.5°C)
1 year
Safety of the Device - Measure of Infant's Increase in Temperature
Time Frame: 1 year
To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.
1 year
Safety of the Device - Local Effect of the Abdominal Belt
Time Frame: 1 year
To evaluate the local effect of the abdominal belt on newborn's skin by looking at any evidence of skin irritation
1 year
Safety of the Device - Incidence of Hyperthermia
Time Frame: 1 year
To evaluate any incidence of hyperthermia (>37.5°C) during the thermoregulation intervention.
1 year
Safety of the Device - Incidence of Rebound Hypothermia
Time Frame: 1 year
To report any incidence of rebound hypothermia ( < 36.5°C) (post-intervention hypothermia) up to 72 hours from the initial encounter.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Marsh Rice University

Collaborators

Muhimbili University of Health and Allied Sciences

Investigators

  • Principal Investigator: Rebecca R Richards-Kortum, PhD, William Marsh Rice University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2022

Primary Completion (Estimated)

August 20, 2024

Study Completion (Estimated)

August 20, 2024

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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