Efficacy of Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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. Effective thermal care for hypothermic newborns is not widely available in low-resource settings due to cost of consumables and spare parts. In this study, the research team wish to evaluate the efficacy of a novel neonatal warming mattress in treating hypothermic newborns. Warming mattress, 'Celsi Warmer', has been developed by Rice 360 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 to 90 eligible infants at the neonatal wards of the Lagos University Teaching Hospital 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 28 days
Healthy Volunteers: f
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⁃ Any neonate who:

• Is currently being treated at study location,

• Is an inborn admission to the neonatal ward,

• Whose parents or guardians provided 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 4.0 kg,

• Has been identified as in need of thermal care defined as having a moderate to severe 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 Kangaroo Mother Care (KMC) for reasons including, but not limited to: a. Mother/guardian unable or unavailable to provide KMC b. Under observation in the Neonatal Intensive Care Unit (NICU) before transfer to KMC c. No space in KMC d. Clinician's discretion;

• May be receiving other medical treatments, including but not limited to, Continuous Positive Airway Pressure (CPAP), oxygen therapy, intravenous (IV) fluids, management and monitoring of common newborn conditions such as hypoglycemia, and/or hyperbilirubinemia.

Locations
Other Locations
Nigeria
University of Lagos, Lagos, Nigeria
RECRUITING
Lagos
Contact Information
Primary
Rebecca Massey, MPH, BSN, RN
rebecca.elias@rice.edu
7133482923
Backup
Sonia Sosa Saenz, BME
soniasosa@rice.edu
Time Frame
Start Date: 2023-08-15
Estimated Completion Date: 2024-10-21
Participants
Target number of participants: 90
Treatments
Experimental: Hypothermic Neonates (90)
A trained study 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 (such that the temperature sensor is positioned using a vertical line from the mid-clavicular line and just below the ribs). The time of sensor placement will be recorded.
Related Therapeutic Areas
Sponsors
Leads: William Marsh Rice University
Collaborators: University of Lagos, Nigeria

This content was sourced from clinicaltrials.gov