Using a warming device to treat hypothermic newborns
Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns
This study tests if a new warming device can help treat newborns with hypothermia in hospitals that have limited resources.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | William Marsh Rice University Academic / other |
| Locations | 1 site (Dar Es Salaam) |
| Trial ID | NCT06000826 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Celsi Warmer, a low-cost device designed to provide thermal care for newborns suffering from hypothermia in low-resource hospital settings. Participants will receive thermal treatment using the Celsi Warmer alongside standard neonatal care, with close monitoring by study personnel. The goal is to determine if this device can effectively warm and monitor newborns in such environments, potentially improving outcomes for affected infants.
Who should consider this trial
Good fit: Ideal candidates are newborns admitted to the neonatal ward who weigh between 1.0 kg and 4.0 kg and require thermal care due to moderate hypothermia.
Not a fit: Patients who are not experiencing hypothermia or those who can be enrolled in Kangaroo Mother Care (KMC) will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a cost-effective solution for managing hypothermia in newborns, improving survival rates in low-resource settings.
How similar studies have performed: Other studies have shown promise in using warming devices for newborns, but the Celsi Warmer's specific application in low-resource settings is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Is currently being treated at study location * Is an inborn admission to the neonatal ward * Whose parents or guardians provided a written 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 4.0kg * Has been identified as in need of thermal care defined as having a moderate 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 KMC for reasons including, but not limited to: 1. Mother/guardian unable or unavailable to provide KMC 2. Under observation in NICU before transfer to KMC 3. No space in KMC 4. Clinician's discretion * May be receiving other medical treatments, including but not limited to, CPAP, oxygen therapy, IV fluids, management and monitoring of common newborn conditions such as hypoglycemia, and/or hyperbilirubinemia via LED phototherapy Exclusion Criteria: * Requires mechanical ventilation * deemed in need of intensive care by the hospital staff who is providing care,including but not limited to: 1. Neonates with severe anemia and/or any suspected hematological disorders, and/or 2. Neonates with obvious congenital anomalies, and/or 3. 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, gastroschisis, known umbilical cord infection, known skin infection * Whose clinician presents concerns about their participation * Is receiving treatment that participation in the study would interfere with, i.e.transferring to KMC
Where this trial is running
Dar Es Salaam
- Muhimbili University of Health and Allied Sciences (MUHAS) — Dar Es Salaam, Tanzania (Recruiting)
Study contacts
- Principal investigator: Rebecca R Richards-Kortum, PhD — William Marsh Rice University
- Study coordinator: Sonia Sosa Saenz, BME
- Email: ss171@rice.edu
- Phone: 713-348-4963
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.