xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06003140</url>
    </required_header>
    <id_info>
      <org_study_id>2023-69</org_study_id>
      <nct_id>NCT06003140</nct_id>
    </id_info>
    <brief_title>Efficacy of Celsi Warmer for the Management of Hypothermic Newborns at the Lagos University Teaching Hospital in Lagos, Nigeria</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>William Marsh Rice University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Lagos, Nigeria</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>William Marsh Rice University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The prevalence of hypothermia across low-resource settings is high, especially in countries&#xD;
        with high neonatal mortality rates. If left untreated, hypothermia can additionally result in&#xD;
        a significant comorbidity, and has been linked to a reduction in the effectiveness of&#xD;
        treatment for other newborn conditions. Effective thermal care for hypothermic newborns is&#xD;
        not widely available in low-resource settings due to cost of consumables and spare parts. In&#xD;
        this study, the research team wish to evaluate the efficacy of a novel neonatal warming&#xD;
        mattress in treating hypothermic newborns. Warming mattress, 'Celsi Warmer', has been&#xD;
        developed by Rice 360 Institute for Global Health Technologies, in conjunction with African&#xD;
        clinicians, to be a robust, low-cost, and easy-to-use warming mattress which can address the&#xD;
        challenges of hypothermia. This is a single-arm, non-randomized, prospective intervention&#xD;
        study. Up to 90 eligible infants at the neonatal wards of the Lagos University Teaching&#xD;
        Hospital will be recruited to evaluate the efficacy of Celsi Warmer in rewarming hypothermic&#xD;
        newborns. Infants temperature will be monitored during thermal intervention and the&#xD;
        performance of the device will be evaluated. The temperatures of each infant will be compared&#xD;
        before, during, and after the intervention.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">October 21, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 21, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns</measure>
      <time_frame>1 year</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Efficacy of the Device</measure>
      <time_frame>1 year</time_frame>
      <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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety of the Device - Rate of Temperature Increase</measure>
      <time_frame>1 year</time_frame>
      <description>To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety of the Device - Local effect of the Abdominal Belt</measure>
      <time_frame>1 year</time_frame>
      <description>To evaluate the local effect of the abdominal belt on newborn's skin by looking at any evidence of skin irritation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety of the Device - Incidence of Hyperthermia</measure>
      <time_frame>1 year</time_frame>
      <description>To evaluate any incidence of hyperthermia (&gt;37.5°C) during the thermoregulation intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety of the Device - Incidence of Rebound Hypothermia</measure>
      <time_frame>1 year</time_frame>
      <description>To report any incidence of rebound hypothermia ( &lt; 36.5°C) (post-intervention hypothermia) up to 72 hours from the initial encounter</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Neonatal Hypothermia</condition>
    <arm_group>
      <arm_group_label>Hypothermic Neonates (90)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Celsi Warmer</intervention_name>
      <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.</description>
      <arm_group_label>Hypothermic Neonates (90)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Any neonate who:&#xD;
  &#xD;
            1. Is currently being treated at study location,&#xD;
  &#xD;
            2. Is an inborn admission to the neonatal ward,&#xD;
  &#xD;
            3. Whose parents or guardians provided informed consent,&#xD;
  &#xD;
            4. Whose parents or guardians providing informed consent are 18 years old or older,&#xD;
  &#xD;
            5. Has a current weight of greater than or equal to 1.0 kg and less than or equal to 4.0&#xD;
               kg,&#xD;
  &#xD;
            6. Has been identified as in need of thermal care defined as having a moderate to severe&#xD;
               hypothermic temperature (32.0-36.0 °C) as the last temperature recorded in hospital&#xD;
               chart, or during recruitment procedures; and&#xD;
  &#xD;
            7. is unable to be enrolled in Kangaroo Mother Care (KMC) for reasons including, but not&#xD;
               limited to: a. Mother/guardian unable or unavailable to provide KMC b. Under&#xD;
               observation in the Neonatal Intensive Care Unit (NICU) before transfer to KMC c. No&#xD;
               space in KMC d. Clinician's discretion;&#xD;
  &#xD;
            8. May be receiving other medical treatments, including but not limited to, Continuous&#xD;
               Positive Airway Pressure (CPAP), oxygen therapy, intravenous (IV) fluids, management&#xD;
               and monitoring of common newborn conditions such as hypoglycemia, and/or&#xD;
               hyperbilirubinemia.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Requires mechanical ventilation;&#xD;
  &#xD;
            2. Is deemed in need of intensive care by the hospital staff who is providing care,&#xD;
               including but not limited to: a. neonates with severe anemia and/or any suspected&#xD;
               hematological disorders, and/or b. Neonates with obvious congenital anomalies, and/or&#xD;
               c. neonates suspected with hypo/hyperthyroidism or any hormonal disorders;&#xD;
  &#xD;
            3. has been diagnosed with birth asphyxia;&#xD;
  &#xD;
            4. Presents a condition that precludes the use of the temperature sensor and/or abdominal&#xD;
               belt including but not limited to, known umbilical cord infection, known skin&#xD;
               infection;&#xD;
  &#xD;
            5. Whose clinician presents concerns about their participation;&#xD;
  &#xD;
            6. Is receiving treatment that participation in the study would interfere with (e.g.&#xD;
               transferring to KMC).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Day</minimum_age>
      <maximum_age>28 Days</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chinyere Ezeaka, MBBS, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>College of Medicine, University of Lagos, Lagos, Nigeria</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rebecca Massey, MPH, BSN, RN</last_name>
      <phone>7133482923</phone>
      <email>rebecca.elias@rice.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sonia Sosa Saenz, BME</last_name>
      <email>soniasosa@rice.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Lagos, Lagos, Nigeria</name>
        <address>
          <city>Lagos</city>
          <country>Nigeria</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chinyere Ezeaka, MBBS</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Nigeria</country>
    </location_countries>
    <reference>
      <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.</citation>
      <PMID>19158799</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>29543861</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>21094417</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>23369256</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33097025</PMID>
    </reference>
    <reference>
      <citation>Ogunlesi TA, Ogunfowora OB, Ogundeyi MM. Prevalence and risk factors for hypothermia on admission in Nigerian babies &lt;72 h of age. J Perinat Med. 2009;37(2):180-4. doi: 10.1515/JPM.2009.014.</citation>
      <PMID>18684103</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypothermia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06003140
  org study id: 2023-69
  nct id: NCT06003140
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns
  time frame: 1 year
  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.
  measure: Efficacy of the Device
  time frame: 1 year
  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)
  measure: Safety of the Device - Rate of Temperature Increase
  time frame: 1 year
  description: To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.
  measure: Safety of the Device - Local effect of the Abdominal Belt
  time frame: 1 year
  description: To evaluate the local effect of the abdominal belt on newborn's skin by looking at any evidence of skin irritation
  measure: Safety of the Device - Incidence of Hyperthermia
  time frame: 1 year
  description: To evaluate any incidence of hyperthermia (>37.5°C) during the thermoregulation intervention.
  measure: Safety of the Device - Incidence of Rebound Hypothermia
  time frame: 1 year
  description: To report any incidence of rebound hypothermia ( < 36.5°C) (post-intervention hypothermia) up to 72 hours from the initial encounter
  arm group label: Hypothermic Neonates (90)
  arm group type: Experimental
  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: Celsi Warmer
  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.
  arm group label: Hypothermic Neonates (90)
  criteria: 
  gender: All
  minimum age: 1 Day
  maximum age: 28 Days
  healthy volunteers: No
  last name: Chinyere Ezeaka, MBBS, MPH
  role: Principal Investigator
  affiliation: College of Medicine, University of Lagos, Lagos, Nigeria
  last name: Rebecca Massey, MPH, BSN, RN
  phone: 7133482923
  email: rebecca.elias@rice.edu
  last name: Sonia Sosa Saenz, BME
  email: soniasosa@rice.edu
  facility: 
  status: Recruiting
  contact: 
  country: Nigeria
  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.
  PMID: 19158799
  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.
  PMID: 29543861
  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.
  PMID: 21094417
  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.
  PMID: 23369256
  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.
  PMID: 33097025
  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.
  PMID: 18684103
  responsible party type: Sponsor
  mesh term: Hypothermia
  sharing ipd: No