Actively Recruiting

Phase Not Applicable
Age: 1Day - 28Days
All Genders
NCT06003140

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

Led by William Marsh Rice University · Updated on 2024-06-07

90

Participants Needed

1

Research Sites

61 weeks

Total Duration

On this page

Sponsors

W

William Marsh Rice University

Lead Sponsor

U

University of Lagos, Nigeria

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Day - 28Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Neonates currently treated at the study location
  • Inborn admission to the neonatal ward
  • Parents or guardians are 18 years or older and have provided informed consent
  • Baby weighs between 1.0 kg and 4.0 kg
  • Baby has moderate to severe hypothermia (32.0-36.0 6C) as last recorded temperature
  • Baby is unable to receive Kangaroo Mother Care due to various reasons such as mother unavailable, NICU observation, no space in KMC, or clinician's decision
  • Baby may be receiving other medical treatments like CPAP, oxygen, IV fluids, or treatment for conditions like hypoglycemia or hyperbilirubinemia
Not Eligible

You will not qualify if you...

  • Baby requires mechanical ventilation
  • Baby needs intensive care due to severe anemia, hematological disorders, congenital anomalies, or hormonal disorders
  • Baby has been diagnosed with birth asphyxia
  • Baby has conditions preventing use of temperature sensor or abdominal belt, like umbilical cord or skin infections
  • Clinician has concerns about baby's participation
  • Baby is receiving treatment that conflicts with study participation, such as transfer to Kangaroo Mother Care

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Lagos, Lagos, Nigeria

Lagos, Nigeria

Actively Recruiting

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Research Team

R

Rebecca Massey, MPH, BSN, RN

CONTACT

S

Sonia Sosa Saenz, BME

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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