Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns at Muhimbili National Hospital, Dar es Salaam, Tanzania

The prevalence of hypothermia across low-resource settings is high, especially in countries with high neonatal mortality rates. If left untreated, hypothermia can additionally result in a significant comorbidity, and has been linked to a reduction in the effectiveness of treatment for other newborn conditions. Thermal care for hypothermic newborns is not widely available in low-resource settings due to cost, and lack of consumables and spare parts. In this study, the research team will evaluate the efficacy of a novel neonatal warming mattress intreating hypothermic newborns. The warming mattress, 'Celsi Warmer', has been developed by Rice360 Institute for Global Health Technologies, in conjunction with African clinicians, to be a robust, low-cost, and easy-to-use warming mattress which can address the challenges of hypothermia. This is a single-arm, non-randomized, prospective intervention study. Up to90eligible infants at Muhimbili National Hospital (MNH) at Upanga Neonatal Unit will be recruited to evaluate the efficacy of Celsi Warmer in rewarming hypothermic newborns. Infants temperature will be monitored during thermal intervention and the performance of the device will be evaluated. The temperatures of each infant will be compared before, during, and after the intervention.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Hypothermia
• Intervention / Treatment: Device: Celsi Warmer Mattress

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Massey, MPH, BSN, RN; Phone Number: 7133482923; Email: rebecca.elias@rice.edu
• Study Contact Backup: Name: Sonia Sosa Saenz, BME; Email: soniasosa@rice.edu

Study Locations

• Tanzania
  • Dar Es Salaam, Tanzania
    • Recruiting
    • Muhimbili National Hospital
    • Contact: Nahya Salim Masoud, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Any neonate who:

1. Is currently being treated at study location
2. Is an inborn admission to the neonatal ward
3. Whose parents or guardians provided a written informed consent
4. Whose parents or guardians providing informed consent are 18 years old or older
5. Has a current weight of greater than or equal to 1.0 kg and less than or equal to 4.0kg
6. 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
7. Is unable to be enrolled in Kangaroo Mother Care (KMC) for reasons including, but not limited to: a.Mother/guardian unable or unavailable to provide KMC b.Under observation in NICU before transfer to KMC c.No space in KMC d.Clinician's discretion
8. 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

The study will not interfere with any other treatment being provided at the ward, and it will not delay the participant from transferring to KMC or being discharged

Exclusion Criteria:

Any neonate who:

1. Requires mechanical ventilation
2. Is deemed in need of intensive care by the hospital staff who is providing care,including but not limited to: a.neonates with severe anemia and/or any suspected hematological disorders, and/or b. Neonates with obvious congenital anomalies, and/or c.neonates suspected with hypo/hyperthyroidism or any hormonal disorders
3. Has been diagnosed with birth asphyxia
4. 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
5. Whose clinician presents concerns about their participation
6. Is receiving treatment that participation in the study would interfere with, i.e.transferring to KMC

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypothermic Neonates (90); Any neonate who 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 will be placed on the Celsi Warmer mattress	Device: Celsi Warmer Mattress; The hypothermic neonate will be placed on the Celsi Warmer mattress and a temperature probe will be placed on the neonate to monitor the temperature of the neonate for up to 24 hours of intervention time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Broad Objective	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	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 Device	To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.	1 year
Safety of Device	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 Device	To evaluate any incidence of hyperthermia (>37.5°C) during the thermoregulation intervention.	1 year
Safety of Device	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

• Sponsor: William Marsh Rice University
• Collaborators: Ifakara Health Institute; Muhimbili University of Health and Allied Sciences; Ministry of Health, Community Development, Gender, Elderly, and Children (MOHCDGEC)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): August 20, 2024
• Study Completion (Estimated): August 20, 2024

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: TZ Celsi Warmer

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