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| Name | Class |
|---|---|
| University of Lagos, Nigeria | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypothermic Neonates (90) | Experimental | A trained study clinician will attach the Celsi Warmer temperature sensor to the abdomen and secure it with the abdominal belt according to the device's instruction manual (such that the temperature sensor is positioned using a vertical line from the mid-clavicular line and just below the ribs). The time of sensor placement will be recorded. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celsi Warmer | Device | A trained study clinician will attach the Celsi Warmer temperature sensor to the abdomen and secure it with the abdominal belt according to the device's instruction manual (such that the temperature sensor is positioned using a vertical line from the mid-clavicular line and just below the ribs). The time of sensor placement will be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns | To evaluate the clinical efficacy and safety of the Celsi Warmer in rewarming hypothermic newborns by comparing the Celsi Warmer's accuracy in measuring neonatal temperature compared to the gold standard, axillary temperature readings. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the Device | To assess the performance of the Celsi Warmer in rewarming hypothermic newborns by measuring the incidence of attainment of normothermia (36.5-37.5°C) | 1 year |
| Safety of the Device - Rate of Temperature Increase |
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Inclusion Criteria:
Any neonate who:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Massey, MPH, BSN, RN | Contact | 7133482923 | rebecca.elias@rice.edu | |
| Sonia Sosa Saenz, BME | Contact | soniasosa@rice.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chinyere Ezeaka, MBBS, MPH | College of Medicine, University of Lagos, Lagos, Nigeria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lagos, Lagos, Nigeria | Recruiting | Lagos | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19158799 | Background | Kumar V, Shearer JC, Kumar A, Darmstadt GL. Neonatal hypothermia in low resource settings: a review. J Perinatol. 2009 Jun;29(6):401-12. doi: 10.1038/jp.2008.233. Epub 2009 Jan 22. | |
| 29543861 | Background | Carns J, Kawaza K, Quinn MK, Miao Y, Guerra R, Molyneux E, Oden M, Richards-Kortum R. Impact of hypothermia on implementation of CPAP for neonatal respiratory distress syndrome in a low-resource setting. PLoS One. 2018 Mar 15;13(3):e0194144. doi: 10.1371/journal.pone.0194144. eCollection 2018. |
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|
To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.
| 1 year |
| Safety of the Device - Local effect of the Abdominal Belt | To evaluate the local effect of the abdominal belt on newborn's skin by looking at any evidence of skin irritation | 1 year |
| Safety of the Device - Incidence of Hyperthermia | To evaluate any incidence of hyperthermia (>37.5°C) during the thermoregulation intervention. | 1 year |
| Safety of the Device - Incidence of Rebound Hypothermia | To report any incidence of rebound hypothermia ( < 36.5°C) (post-intervention hypothermia) up to 72 hours from the initial encounter | 1 year |
| 21094417 | Background | Mullany LC. Neonatal hypothermia in low-resource settings. Semin Perinatol. 2010 Dec;34(6):426-33. doi: 10.1053/j.semperi.2010.09.007. |
| 23369256 | Background | Lunze K, Bloom DE, Jamison DT, Hamer DH. The global burden of neonatal hypothermia: systematic review of a major challenge for newborn survival. BMC Med. 2013 Jan 31;11:24. doi: 10.1186/1741-7015-11-24. |
| 33097025 | Background | Cavallin F, Calgaro S, Brugnolaro V, Seni AHA, Muhelo AR, Da Dalt L, Putoto G, Trevisanuto D. Impact of temperature change from admission to day one on neonatal mortality in a low-resource setting. BMC Pregnancy Childbirth. 2020 Oct 23;20(1):646. doi: 10.1186/s12884-020-03343-7. |
| 18684103 | Background | Ogunlesi TA, Ogunfowora OB, Ogundeyi MM. Prevalence and risk factors for hypothermia on admission in Nigerian babies <72 h of age. J Perinat Med. 2009;37(2):180-4. doi: 10.1515/JPM.2009.014. |