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/NCT06000826</url>
    </required_header>
    <id_info>
      <org_study_id>2022-271</org_study_id>
      <nct_id>NCT06000826</nct_id>
    </id_info>
    <brief_title>Efficacy of Celsi Warmer for the Management of Hypothermic Newborns</brief_title>
    <official_title>Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>William Marsh Rice University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Muhimbili University of Health and Allied Sciences</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 purpose of the study is to evaluate the efficacy of a novel low-cost warming device to&#xD;
        provide thermal care for newborn babies with hypothermia in low-resource hospitals. During&#xD;
        the study, research participants will receive thermal care via the Celsi Warmer. Aside from&#xD;
        thermal treatment, research participants will receive the standard of care from the neonatal&#xD;
        unit, and will also be closely monitored by study personnel throughout the study. The results&#xD;
        from this study will allow us to determine if the Celsi Warmer is an effective tool for&#xD;
        warming and monitoring newborns in wards of low-resource hospitals. The research team hopes&#xD;
        to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn&#xD;
        hypothermia in hospitals in low-resource settings.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 27, 2022</start_date>
    <completion_date type="Anticipated">August 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 20, 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 - Measure of Infant's Increase in Temperature</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>Newborn Hypothermia</condition>
    <arm_group>
      <arm_group_label>Neonatal</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A trained study nurse or clinician will transfer the enrolled participant to the study location and place the infant on the Celsi Warmer mattress.&#xD;
  A trained study nurse or 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&#xD;
  A trained study nurse or clinician will wrap the baby according to the standard care at the hospital.&#xD;
  Study personnel may observe the participant during the intervention period and annotate timestamped events that might affect temperature measurement and/or thermoregulation support intervention.&#xD;
  Study personnel will perform routine abdominal skin assessments as often as every two hours and at least every 8 hours to observe for skin irritation or indentation.&#xD;
  Thermoregulation support intervention will be provided as long as the infant continues to meet criteria for continued care at clinician's discretion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Celsi Warmer</intervention_name>
      <description>During the study, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow the research team to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.</description>
      <arm_group_label>Neonatal</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Is currently being treated at study location&#xD;
  &#xD;
            -  Is an inborn admission to the neonatal ward&#xD;
  &#xD;
            -  Whose parents or guardians provided a written informed consent&#xD;
  &#xD;
            -  Whose parents or guardians providing informed consent are 18 years old or older&#xD;
  &#xD;
            -  Has a current weight of greater than or equal to 1.0 kg and less than or equal to&#xD;
               4.0kg&#xD;
  &#xD;
            -  Has been identified as in need of thermal care defined as having a moderate&#xD;
               hypothermic temperature (32.0-36.0°C) as the last temperature recorded in hospital&#xD;
               chart, or during recruitment procedures; and&#xD;
  &#xD;
            -  Is unable to be enrolled in KMC for reasons including, but not limited to:&#xD;
  &#xD;
                 1. Mother/guardian unable or unavailable to provide KMC&#xD;
  &#xD;
                 2. Under observation in NICU before transfer to KMC&#xD;
  &#xD;
                 3. No space in KMC&#xD;
  &#xD;
                 4. Clinician's discretion&#xD;
  &#xD;
            -  May be receiving other medical treatments, including but not limited to, CPAP, oxygen&#xD;
               therapy, IV fluids, management and monitoring of common newborn conditions such as&#xD;
               hypoglycemia, and/or hyperbilirubinemia via LED phototherapy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Requires mechanical ventilation&#xD;
  &#xD;
            -  deemed in need of intensive care by the hospital staff who is providing care,including&#xD;
               but not limited to:&#xD;
  &#xD;
                 1. Neonates with severe anemia and/or any suspected hematological disorders, and/or&#xD;
  &#xD;
                 2. Neonates with obvious congenital anomalies, and/or&#xD;
  &#xD;
                 3. neonates suspected with hypo/hyperthyroidism or any hormonal disorders&#xD;
  &#xD;
            -  Has been diagnosed with birth asphyxia&#xD;
  &#xD;
            -  Presents a condition that precludes the use of the temperature sensor and/or abdominal&#xD;
               belt including but not limited to, gastroschisis, known umbilical cord infection,&#xD;
               known skin infection&#xD;
  &#xD;
            -  Whose clinician presents concerns about their participation&#xD;
  &#xD;
            -  Is receiving treatment that participation in the study would interfere with,&#xD;
               i.e.transferring to KMC&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Days</minimum_age>
      <maximum_age>28 Days</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rebecca R Richards-Kortum, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>William Marsh Rice University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sonia Sosa Saenz, BME</last_name>
      <phone>713-348-4963</phone>
      <email>ss171@rice.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Natalie Mitchell</last_name>
      <email>natalie.d.mitchell@rice.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Muhimbili University of Health and Allied Sciences (MUHAS)</name>
        <address>
          <city>Dar Es Salaam</city>
          <country>Tanzania</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nahya Salim, MMED</last_name>
        <phone>+255 713 250074</phone>
        <email>nsalim@ihi.or.tz</email>
      </contact>
      <contact_backup>
        <last_name>Robert Moshiro, MMED</last_name>
        <phone>+255 713 35</phone>
        <email>moshiror@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Rebecca R Richards-Kortum, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Maria Oden, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Tanzania</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>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>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>Manji KP, Kisenge R. Neonatal hypothermia on admission to a special care unit in Dar-es-Salaam, Tanzania: a cause for concern. Cent Afr J Med. 2003 Mar-Apr;49(3-4):23-7.</citation>
      <PMID>14562586</PMID>
    </reference>
    <reference>
      <citation>Laptook AR, Salhab W, Bhaskar B; Neonatal Research Network. Admission temperature of low birth weight infants: predictors and associated morbidities. Pediatrics. 2007 Mar;119(3):e643-9. doi: 10.1542/peds.2006-0943. Epub 2007 Feb 12.</citation>
      <PMID>17296783</PMID>
    </reference>
    <reference>
      <citation>Lunze K, Hamer DH. Thermal protection of the newborn in resource-limited environments. J Perinatol. 2012 May;32(5):317-24. doi: 10.1038/jp.2012.11. Epub 2012 Mar 1.</citation>
      <PMID>22382859</PMID>
    </reference>
    <reference>
      <citation>de Almeida MF, Guinsburg R, Sancho GA, Rosa IR, Lamy ZC, Martinez FE, da Silva RP, Ferrari LS, de Souza Rugolo LM, Abdallah VO, Silveira Rde C; Brazilian Network on Neonatal Research. Hypothermia and early neonatal mortality in preterm infants. J Pediatr. 2014 Feb;164(2):271-5.e1. doi: 10.1016/j.jpeds.2013.09.049. Epub 2013 Nov 6.</citation>
      <PMID>24210925</PMID>
    </reference>
    <reference>
      <citation>ADAMSON SK Jr, TOWELL ME. THERMAL HOMEOSTASIS IN THE FETUS AND NEWBORN. Anesthesiology. 1965 Jul-Aug;26:531-48. doi: 10.1097/00000542-196507000-00017. No abstract available.</citation>
      <PMID>14313463</PMID>
    </reference>
    <reference>
      <citation>Nahimana E, May L, Gadgil A, Rapp V, Magge H, Kubwimana M, Nshimyiryo A, Kateera F, Feldman HA, Nkikabahizi F, Sayinzoga F, Hansen A. A low cost, re-usable electricity-free infant warmer: evaluation of safety, effectiveness and feasibiliy. Public Health Action. 2018 Dec 21;8(4):211-217. doi: 10.5588/pha.18.0031.</citation>
      <PMID>30775282</PMID>
    </reference>
    <reference>
      <citation>Wyllie J, Perlman JM, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation. 2015 Oct;95:e169-201. doi: 10.1016/j.resuscitation.2015.07.045. Epub 2015 Oct 15. No abstract available.</citation>
      <PMID>26477424</PMID>
    </reference>
    <reference>
      <citation>Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres J, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2020 Oct 20;142(16_suppl_1):S185-S221. doi: 10.1161/CIR.0000000000000895. Epub 2020 Oct 21.</citation>
      <PMID>33084392</PMID>
    </reference>
    <reference>
      <citation>WHO Immediate KMC Study Group; Arya S, Naburi H, Kawaza K, Newton S, Anyabolu CH, Bergman N, Rao SPN, Mittal P, Assenga E, Gadama L, Larsen-Reindorf R, Kuti O, Linner A, Yoshida S, Chopra N, Ngarina M, Msusa AT, Boakye-Yiadom A, Kuti BP, Morgan B, Minckas N, Suri J, Moshiro R, Samuel V, Wireko-Brobby N, Rettedal S, Jaiswal HV, Sankar MJ, Nyanor I, Tiwary H, Anand P, Manu AA, Nagpal K, Ansong D, Saini I, Aggarwal KC, Wadhwa N, Bahl R, Westrup B, Adejuyigbe EA, Plange-Rhule G, Dube Q, Chellani H, Massawe A. Immediate &quot;Kangaroo Mother Care&quot; and Survival of Infants with Low Birth Weight. N Engl J Med. 2021 May 27;384(21):2028-2038. doi: 10.1056/NEJMoa2026486.</citation>
      <PMID>34038632</PMID>
    </reference>
    <reference>
      <citation>Ahmed S, Mitra SN, Chowdhury AM, Camacho LL, Winikoff B, Sloan NL. Community Kangaroo Mother Care: implementation and potential for neonatal survival and health in very low-income settings. J Perinatol. 2011 May;31(5):361-7. doi: 10.1038/jp.2010.131. Epub 2011 Feb 10.</citation>
      <PMID>21311502</PMID>
    </reference>
    <reference>
      <citation>Lee HC, Martin-Anderson S, Dudley RA. Clinician perspectives on barriers to and opportunities for skin-to-skin contact for premature infants in neonatal intensive care units. Breastfeed Med. 2012 Apr;7(2):79-84. doi: 10.1089/bfm.2011.0004. Epub 2011 Oct 19.</citation>
      <PMID>22011130</PMID>
    </reference>
    <reference>
      <citation>Flenady VJ, Woodgate PG. Radiant warmers versus incubators for regulating body temperature in newborn infants. Cochrane Database Syst Rev. 2000;(2):CD000435. doi: 10.1002/14651858.CD000435.</citation>
      <PMID>10796363</PMID>
    </reference>
    <reference>
      <citation>Trevisanuto D, Coretti I, Doglioni N, Udilano A, Cavallin F, Zanardo V. Effective temperature under radiant infant warmer: does the device make a difference? Resuscitation. 2011 Jun;82(6):720-3. doi: 10.1016/j.resuscitation.2011.02.019. Epub 2011 Mar 24.</citation>
      <PMID>21439704</PMID>
    </reference>
    <reference>
      <citation>Butin M, Dumont Y, Monteix A, Raphard A, Roques C, Martins Simoes P, Picaud JC, Laurent F. Sources and reservoirs of Staphylococcus capitis NRCS-A inside a NICU. Antimicrob Resist Infect Control. 2019 Oct 17;8:157. doi: 10.1186/s13756-019-0616-1. eCollection 2019.</citation>
      <PMID>31636900</PMID>
    </reference>
    <reference>
      <citation>Cadot L, Bruguiere H, Jumas-Bilak E, Didelot MN, Masnou A, de Barry G, Cambonie G, Parer S, Romano-Bertrand S. Extended spectrum beta-lactamase-producing Klebsiella pneumoniae outbreak reveals incubators as pathogen reservoir in neonatal care center. Eur J Pediatr. 2019 Apr;178(4):505-513. doi: 10.1007/s00431-019-03323-w. Epub 2019 Jan 23.</citation>
      <PMID>30671695</PMID>
    </reference>
    <reference>
      <citation>Nimbalkar S, Patel H, Dongara A, Patel DV, Bansal S. Usage of EMBRACE(TM) in Gujarat, India: Survey of Paediatricians. Adv Prev Med. 2014;2014:415301. doi: 10.1155/2014/415301. Epub 2014 Oct 30.</citation>
      <PMID>25530887</PMID>
    </reference>
    <reference>
      <citation>Boo NY, Selvarani S. Effectiveness of a simple heated water-filled mattress for the prevention and treatment of neonatal hypothermia in the labour room. Singapore Med J. 2005 Aug;46(8):387-91.</citation>
      <PMID>16049607</PMID>
    </reference>
    <reference>
      <citation>McNichol L, Lund C, Rosen T, Gray M. Medical adhesives and patient safety: state of the science: consensus statements for the assessment, prevention, and treatment of adhesive-related skin injuries. J Wound Ostomy Continence Nurs. 2013 Jul-Aug;40(4):365-80; quiz E1-2. doi: 10.1097/WON.0b013e3182995516.</citation>
      <PMID>23759927</PMID>
    </reference>
    <reference>
      <citation>Uwamariya J, Mazimpaka C, May L, Nshimyiryo A, Feldman HA, Sayinzoga F, Umutesi S, Gadgil A, Rapp VH, Nahimana E, Hansen A. Safety and effectiveness of a non-electric infant warmer for hypothermia in Rwanda: A cluster-randomized stepped-wedge trial. EClinicalMedicine. 2021 Apr 16;34:100842. doi: 10.1016/j.eclinm.2021.100842. eCollection 2021 Apr.</citation>
      <PMID>33997734</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 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/NCT06000826
  org study id: 2022-271
  nct id: NCT06000826
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study is to evaluate the efficacy of a novel low-cost warming device to
        provide thermal care for newborn babies with hypothermia in low-resource hospitals. During
        the study, research participants will receive thermal care via the Celsi Warmer. Aside from
        thermal treatment, research participants will receive the standard of care from the neonatal
        unit, and will also be closely monitored by study personnel throughout the study. The results
        from this study will allow us to determine if the Celsi Warmer is an effective tool for
        warming and monitoring newborns in wards of low-resource hospitals. The research team hopes
        to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn
        hypothermia in hospitals in low-resource settings.
  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 - Measure of Infant's Increase in Temperature
  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: Neonatal
  arm group type: Experimental
  description: A trained study nurse or clinician will transfer the enrolled participant to the study location and place the infant on the Celsi Warmer mattress.
  A trained study nurse or 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
  A trained study nurse or clinician will wrap the baby according to the standard care at the hospital.
  Study personnel may observe the participant during the intervention period and annotate timestamped events that might affect temperature measurement and/or thermoregulation support intervention.
  Study personnel will perform routine abdominal skin assessments as often as every two hours and at least every 8 hours to observe for skin irritation or indentation.
  Thermoregulation support intervention will be provided as long as the infant continues to meet criteria for continued care at clinician's discretion.
  intervention type: Device
  intervention name: Celsi Warmer
  description: During the study, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow the research team to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.
  arm group label: Neonatal
  criteria: 
  gender: All
  minimum age: 0 Days
  maximum age: 28 Days
  healthy volunteers: No
  last name: Rebecca R Richards-Kortum, PhD
  role: Principal Investigator
  affiliation: William Marsh Rice University
  last name: Sonia Sosa Saenz, BME
  phone: 713-348-4963
  email: ss171@rice.edu
  last name: Natalie Mitchell
  email: natalie.d.mitchell@rice.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Tanzania
  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: 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: 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: Manji KP, Kisenge R. Neonatal hypothermia on admission to a special care unit in Dar-es-Salaam, Tanzania: a cause for concern. Cent Afr J Med. 2003 Mar-Apr;49(3-4):23-7.
  PMID: 14562586
  citation: Laptook AR, Salhab W, Bhaskar B; Neonatal Research Network. Admission temperature of low birth weight infants: predictors and associated morbidities. Pediatrics. 2007 Mar;119(3):e643-9. doi: 10.1542/peds.2006-0943. Epub 2007 Feb 12.
  PMID: 17296783
  citation: Lunze K, Hamer DH. Thermal protection of the newborn in resource-limited environments. J Perinatol. 2012 May;32(5):317-24. doi: 10.1038/jp.2012.11. Epub 2012 Mar 1.
  PMID: 22382859
  citation: de Almeida MF, Guinsburg R, Sancho GA, Rosa IR, Lamy ZC, Martinez FE, da Silva RP, Ferrari LS, de Souza Rugolo LM, Abdallah VO, Silveira Rde C; Brazilian Network on Neonatal Research. Hypothermia and early neonatal mortality in preterm infants. J Pediatr. 2014 Feb;164(2):271-5.e1. doi: 10.1016/j.jpeds.2013.09.049. Epub 2013 Nov 6.
  PMID: 24210925
  citation: ADAMSON SK Jr, TOWELL ME. THERMAL HOMEOSTASIS IN THE FETUS AND NEWBORN. Anesthesiology. 1965 Jul-Aug;26:531-48. doi: 10.1097/00000542-196507000-00017. No abstract available.
  PMID: 14313463
  citation: Nahimana E, May L, Gadgil A, Rapp V, Magge H, Kubwimana M, Nshimyiryo A, Kateera F, Feldman HA, Nkikabahizi F, Sayinzoga F, Hansen A. A low cost, re-usable electricity-free infant warmer: evaluation of safety, effectiveness and feasibiliy. Public Health Action. 2018 Dec 21;8(4):211-217. doi: 10.5588/pha.18.0031.
  PMID: 30775282
  citation: Wyllie J, Perlman JM, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation. 2015 Oct;95:e169-201. doi: 10.1016/j.resuscitation.2015.07.045. Epub 2015 Oct 15. No abstract available.
  PMID: 26477424
  citation: Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres J, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2020 Oct 20;142(16_suppl_1):S185-S221. doi: 10.1161/CIR.0000000000000895. Epub 2020 Oct 21.
  PMID: 33084392
  citation: WHO Immediate KMC Study Group; Arya S, Naburi H, Kawaza K, Newton S, Anyabolu CH, Bergman N, Rao SPN, Mittal P, Assenga E, Gadama L, Larsen-Reindorf R, Kuti O, Linner A, Yoshida S, Chopra N, Ngarina M, Msusa AT, Boakye-Yiadom A, Kuti BP, Morgan B, Minckas N, Suri J, Moshiro R, Samuel V, Wireko-Brobby N, Rettedal S, Jaiswal HV, Sankar MJ, Nyanor I, Tiwary H, Anand P, Manu AA, Nagpal K, Ansong D, Saini I, Aggarwal KC, Wadhwa N, Bahl R, Westrup B, Adejuyigbe EA, Plange-Rhule G, Dube Q, Chellani H, Massawe A. Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight. N Engl J Med. 2021 May 27;384(21):2028-2038. doi: 10.1056/NEJMoa2026486.
  PMID: 34038632
  citation: Ahmed S, Mitra SN, Chowdhury AM, Camacho LL, Winikoff B, Sloan NL. Community Kangaroo Mother Care: implementation and potential for neonatal survival and health in very low-income settings. J Perinatol. 2011 May;31(5):361-7. doi: 10.1038/jp.2010.131. Epub 2011 Feb 10.
  PMID: 21311502
  citation: Lee HC, Martin-Anderson S, Dudley RA. Clinician perspectives on barriers to and opportunities for skin-to-skin contact for premature infants in neonatal intensive care units. Breastfeed Med. 2012 Apr;7(2):79-84. doi: 10.1089/bfm.2011.0004. Epub 2011 Oct 19.
  PMID: 22011130
  citation: Flenady VJ, Woodgate PG. Radiant warmers versus incubators for regulating body temperature in newborn infants. Cochrane Database Syst Rev. 2000;(2):CD000435. doi: 10.1002/14651858.CD000435.
  PMID: 10796363
  citation: Trevisanuto D, Coretti I, Doglioni N, Udilano A, Cavallin F, Zanardo V. Effective temperature under radiant infant warmer: does the device make a difference? Resuscitation. 2011 Jun;82(6):720-3. doi: 10.1016/j.resuscitation.2011.02.019. Epub 2011 Mar 24.
  PMID: 21439704
  citation: Butin M, Dumont Y, Monteix A, Raphard A, Roques C, Martins Simoes P, Picaud JC, Laurent F. Sources and reservoirs of Staphylococcus capitis NRCS-A inside a NICU. Antimicrob Resist Infect Control. 2019 Oct 17;8:157. doi: 10.1186/s13756-019-0616-1. eCollection 2019.
  PMID: 31636900
  citation: Cadot L, Bruguiere H, Jumas-Bilak E, Didelot MN, Masnou A, de Barry G, Cambonie G, Parer S, Romano-Bertrand S. Extended spectrum beta-lactamase-producing Klebsiella pneumoniae outbreak reveals incubators as pathogen reservoir in neonatal care center. Eur J Pediatr. 2019 Apr;178(4):505-513. doi: 10.1007/s00431-019-03323-w. Epub 2019 Jan 23.
  PMID: 30671695
  citation: Nimbalkar S, Patel H, Dongara A, Patel DV, Bansal S. Usage of EMBRACE(TM) in Gujarat, India: Survey of Paediatricians. Adv Prev Med. 2014;2014:415301. doi: 10.1155/2014/415301. Epub 2014 Oct 30.
  PMID: 25530887
  citation: Boo NY, Selvarani S. Effectiveness of a simple heated water-filled mattress for the prevention and treatment of neonatal hypothermia in the labour room. Singapore Med J. 2005 Aug;46(8):387-91.
  PMID: 16049607
  citation: McNichol L, Lund C, Rosen T, Gray M. Medical adhesives and patient safety: state of the science: consensus statements for the assessment, prevention, and treatment of adhesive-related skin injuries. J Wound Ostomy Continence Nurs. 2013 Jul-Aug;40(4):365-80; quiz E1-2. doi: 10.1097/WON.0b013e3182995516.
  PMID: 23759927
  citation: Uwamariya J, Mazimpaka C, May L, Nshimyiryo A, Feldman HA, Sayinzoga F, Umutesi S, Gadgil A, Rapp VH, Nahimana E, Hansen A. Safety and effectiveness of a non-electric infant warmer for hypothermia in Rwanda: A cluster-randomized stepped-wedge trial. EClinicalMedicine. 2021 Apr 16;34:100842. doi: 10.1016/j.eclinm.2021.100842. eCollection 2021 Apr.
  PMID: 33997734
  responsible party type: Sponsor
  mesh term: Hypothermia
  sharing ipd: No