Using a warming mattress to treat hypothermic newborns in Lagos, Nigeria
Efficacy of Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria
This study is testing a new warming mattress to see if it can help treat newborns with low body temperature in Lagos, Nigeria.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 1 Day to 28 Days |
| Sex | All |
| Sponsor | William Marsh Rice University Academic / other |
| Locations | 1 site (Lagos) |
| Trial ID | NCT06003140 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of the Celsi Warmer, a novel neonatal warming mattress designed to provide effective thermal care for hypothermic newborns in low-resource settings. Conducted at the Lagos University Teaching Hospital, the study aims to enroll up to 90 eligible infants who are in need of thermal care due to moderate to severe hypothermia. The Celsi Warmer is developed to be low-cost, robust, and easy to use, addressing the challenges faced in treating hypothermia in newborns. This is a single-arm, non-randomized, prospective intervention study.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns admitted to the neonatal ward who are identified as needing thermal care due to moderate to severe hypothermia.
Not a fit: Patients who are not experiencing hypothermia or those who can be enrolled in Kangaroo Mother Care may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of hypothermic newborns, potentially reducing neonatal mortality rates in low-resource settings.
How similar studies have performed: While this specific approach is novel, similar studies in low-resource settings have shown promise in improving thermal care for newborns.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 4.0 kg, 6. 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 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 the Neonatal Intensive Care Unit (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, Continuous Positive Airway Pressure (CPAP), oxygen therapy, intravenous (IV) fluids, management and monitoring of common newborn conditions such as hypoglycemia, and/or hyperbilirubinemia. Exclusion Criteria: 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, 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 (e.g. transferring to KMC).
Where this trial is running
Lagos
- University of Lagos, Lagos, Nigeria — Lagos, Nigeria (Recruiting)
Study contacts
- Principal investigator: Chinyere Ezeaka, MBBS, MPH — College of Medicine, University of Lagos, Lagos, Nigeria
- Study coordinator: Rebecca Massey, MPH, BSN, RN
- Email: rebecca.elias@rice.edu
- Phone: 7133482923
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.