Neonatal hypothermia in low resource settings: a review.
V Kumar, J C Shearer, A Kumar...
https://pubmed.ncbi.nlm.nih.gov/19158799Actively Recruiting
Phase Not Applicable
Age: 1Day - 28Days
All Genders
ID06003140
Efficacy of Low-cost Warming Mattress 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
N/A
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
Neonatal hypothermia is common in low-resource settings and is linked to higher risks of illness and reduced treatment effectiveness for newborns. Researchers are evaluating a new warming mattress called the Celsi Warmer, designed to be low-cost, durable, and easy to use in such environments. This study aims to test how well the Celsi Warmer can rewarm hypothermic newborns at a hospital in Lagos, Nigeria, with support from Rice 360 Institute for Global Health Technologies and local clinicians. The study involves up to 90 newborns treated at the neonatal ward who have moderate to severe hypothermia. A trained clinician will place the Celsi Warmer temperature sensor on the infant's abdomen and secure it with an abdominal belt according to instructions. The device's performance will be monitored by recording the infants' temperatures before, during, and after using the warmer. Participants will have their body temperatures closely monitored throughout the thermal treatment to assess the device's efficacy and safety. Researchers will check for temperature changes, any local effects from the belt, and occurrences of overheating or rebound hypothermia. The study will also compare the Celsi Warmer's results to standard rewarming methods. This careful monitoring will continue for the full year of study follow-up.
CONDITIONS
Brief 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
You may qualify if you...
- Neonates currently being treated at the study hospital
- Inborn admission to the neonatal ward
- Parents or guardians aged 18 years or older have provided informed consent
- Baby's weight is between 1.0 kg and 4.0 kg
- Baby has moderate to severe hypothermia (temperature between 32.0 and 36.0 �B0C)
- Baby is unable to receive Kangaroo Mother Care due to reasons like unavailability of mother/guardian, NICU observation, lack of space, or clinician's decision
- Baby may be receiving other medical treatments such as CPAP, oxygen, IV fluids, or management of common newborn conditions
You will not qualify if you...
- Requires mechanical ventilation
- Needs intensive care due to severe anemia, hematological disorders, congenital anomalies, or hormonal disorders
- Diagnosed with birth asphyxia
- Has conditions preventing use of the temperature sensor or abdominal belt, such as umbilical cord or skin infections
- Clinician has concerns about participation
- Receiving treatments that would conflict with study participation, such as transfer to Kangaroo Mother Care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 1 year
Participants receive the Celsi Warmer device attached to their abdomen by a trained clinician to manage hypothermia.
Visits as needed for device management and monitoring over the study period
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
S
Sonia Sosa Saenz, BME
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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Published Research Related To This Trial
Impact of hypothermia on implementation of CPAP for neonatal respiratory distress syndrome in a low-resource setting.
Jennifer Carns, Kondwani Kawaza, M K Quinn...
https://pubmed.ncbi.nlm.nih.gov/29543861Neonatal hypothermia in low-resource settings.
Luke C Mullany
https://pubmed.ncbi.nlm.nih.gov/21094417The global burden of neonatal hypothermia: systematic review of a major challenge for newborn survival.
Karsten Lunze, David E Bloom, Dean T Jamison...
https://pubmed.ncbi.nlm.nih.gov/23369256Impact of temperature change from admission to day one on neonatal mortality in a low-resource setting.
Francesco Cavallin, Serena Calgaro, Valentina Brugnolaro...
https://pubmed.ncbi.nlm.nih.gov/33097025Prevalence and risk factors for hypothermia on admission in Nigerian babies <72 h of age.
Tinuade A Ogunlesi, Olusoga B Ogunfowora, Mojisola M Ogundeyi
https://pubmed.ncbi.nlm.nih.gov/18684103