An interventional study of Celsi Warmer Mattress in Neonatal Hypothermia, sponsored by William Marsh Rice University. Recruiting at 1 site in Tanzania. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by William Marsh Rice University · Not applicable, Interventional, and Treatment
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. Thermal care for hypothermic newborns is not widely available in low-resource settings due to cost, and lack of consumables and spare parts. In this study, the research team will evaluate the efficacy of a novel neonatal warming mattress intreating hypothermic newborns. The warming mattress, 'Celsi Warmer', has been developed by Rice360 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 to90eligible infants at Muhimbili National Hospital (MNH) at Upanga Neonatal Unit 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.
449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
This study's planned enrollment of 90 is above the median of 77 across 328 interventional studies indexed under Hypothermia.
Browse Hypothermia studies →William Marsh Rice University is the lead sponsor of 17 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Any neonate who:
The study will not interfere with any other treatment being provided at the ward, and it will not delay the participant from transferring to KMC or being discharged
Exclusion Criteria:
Any neonate who:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Any neonate who 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 will be placed on the Celsi Warmer mattress
Device: Celsi Warmer Mattress
The hypothermic neonate will be placed on the Celsi Warmer mattress and a temperature probe will be placed on the neonate to monitor the temperature of the neonate for up to 24 hours of intervention time
Broad Objective
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.
Time frame: 1 year
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)
Time frame: 1 year
Safety of Device
To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.
Time frame: 1 year
Safety of Device
To evaluate the local effect of the abdominal belt on newborn's skin by looking at any evidence of skin irritation
Time frame: 1 year
Safety of Device
To evaluate any incidence of hyperthermia (\>37.5°C) during the thermoregulation intervention.
Time frame: 1 year
Safety of Device
To report any incidence of rebound hypothermia ( \< 36.5°C) (post-intervention hypothermia) up to 72 hours from the initial encounter
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for Aug 2024, 24 months after the start.
Of 132 non-industry interventional studies with no phase under Hypothermia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 24 months is above that.
Counting every sponsor, half of 135 studies reached it within 16 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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