Efficacy of Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-28
SponsorWilliam Marsh Rice University

About this trial

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 criteria

Qualifiers

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,

Disqualifiers

Requires mechanical ventilation;

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;

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, known umbilical cord infection, known skin infection;

Trial design

Treatments tested in this trial

  • Celsi Warmer

Treatment groups

90 Participants
are divided into 1 treatment group

Sponsors and collaborators

William Marsh Rice University

Lead sponsor

University of Lagos, Nigeria

Collaborator