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Efficacy of Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria

Primary Purpose

Neonatal Hypothermia

Status
Recruiting
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Celsi Warmer
Sponsored by
William Marsh Rice University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Hypothermia

Eligibility Criteria

1 Day - 28 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Any neonate who: Is currently being treated at study location, Is an inborn admission to the neonatal ward, Whose parents or guardians provided 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 4.0 kg, 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 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; 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: Requires mechanical ventilation; 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; 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, 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 (e.g. transferring to KMC).

Sites / Locations

  • University of Lagos, Lagos, NigeriaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypothermic Neonates (90)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Safety of the Device - Rate of Temperature Increase
To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.
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
Safety of the Device - Incidence of Hyperthermia
To evaluate any incidence of hyperthermia (>37.5°C) during the thermoregulation intervention.
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

Full Information

First Posted
May 31, 2023
Last Updated
August 21, 2023
Sponsor
William Marsh Rice University
Collaborators
University of Lagos, Nigeria
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1. Study Identification

Unique Protocol Identification Number
NCT06003140
Brief Title
Efficacy of Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria
Official Title
Efficacy of Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Anticipated)
Primary Completion Date
October 21, 2024 (Anticipated)
Study Completion Date
October 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
William Marsh Rice University
Collaborators
University of Lagos, Nigeria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypothermic Neonates (90)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Celsi Warmer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns
Description
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
Secondary Outcome Measure Information:
Title
Efficacy of the Device
Description
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
Title
Safety of the Device - Rate of Temperature Increase
Description
To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.
Time Frame
1 year
Title
Safety of the Device - Local effect of the Abdominal Belt
Description
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
Title
Safety of the Device - Incidence of Hyperthermia
Description
To evaluate any incidence of hyperthermia (>37.5°C) during the thermoregulation intervention.
Time Frame
1 year
Title
Safety of the Device - Incidence of Rebound Hypothermia
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any neonate who: Is currently being treated at study location, Is an inborn admission to the neonatal ward, Whose parents or guardians provided 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 4.0 kg, 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 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; 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: Requires mechanical ventilation; 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; 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, 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 (e.g. transferring to KMC).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Massey, MPH, BSN, RN
Phone
7133482923
Email
rebecca.elias@rice.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia Sosa Saenz, BME
Email
soniasosa@rice.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chinyere Ezeaka, MBBS, MPH
Organizational Affiliation
College of Medicine, University of Lagos, Lagos, Nigeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Lagos, Lagos, Nigeria
City
Lagos
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chinyere Ezeaka, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19158799
Citation
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.
Results Reference
background
PubMed Identifier
29543861
Citation
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.
Results Reference
background
PubMed Identifier
21094417
Citation
Mullany LC. Neonatal hypothermia in low-resource settings. Semin Perinatol. 2010 Dec;34(6):426-33. doi: 10.1053/j.semperi.2010.09.007.
Results Reference
background
PubMed Identifier
23369256
Citation
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.
Results Reference
background
PubMed Identifier
33097025
Citation
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.
Results Reference
background
PubMed Identifier
18684103
Citation
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.
Results Reference
background

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Efficacy of Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria

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