<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/NCT01671241</url>
  </required_header>
  <id_info>
    <org_study_id>LossPreventionTotalBodyWrap</org_study_id>
    <nct_id>NCT01671241</nct_id>
  </id_info>
  <brief_title>Heat Loss Prevention in Very Preterm Infants in Delivery Rooms: A Multicenter, Randomized, Controlled Trial of Polyethylene Occlusive Total Body Skin Wrapping</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Padova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Padova</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothermia after delivery is a world-wide problem associated with morbidity and mortality.&#xD;
      The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is&#xD;
      unsuccessful in a large proportion of very preterm infants. Polyethylene occlusive skin&#xD;
      wrapping covering the infant's body up to the neck will reduce postnatal heat loss in very&#xD;
      preterm babies and represents the standard of care recommended by the International&#xD;
      Guidelines for Neonatal Resuscitation. The use of a polyethylene head cap will also reduce&#xD;
      heat loss 9 and its efficacy is comparable to that obtained with the wrap. However, the&#xD;
      proportions of hypothermic infants at NICU admission (temperature &lt;34°C) in the wrapped group&#xD;
      (62%) as well as in the infants covered with a polyethylene cap (43%) remain high. The&#xD;
      combination of body and head protection with a polyethylene wrap needs to be evaluated&#xD;
      further. The investigators conducted a prospective, randomized, controlled trial in very&#xD;
      preterm infants to evaluate whether a polyethylene total body wrapping (body plus head)&#xD;
      prevents heat loss after delivery better than polyethylene occlusive wrapping.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2011</start_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality prior to hospital discharge</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major brain injury</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentages of hyperthermic infants at NICU admission</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Hypothermia</condition>
  <condition>Preterm Infant</condition>
  <arm_group>
    <arm_group_label>Total body polyethylene wrap (body plus head)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The entire body surface (body plus head) is covered by a polyethylene wrap</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Polyethylene wrap (body)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A polyethylene wrap covers the patient's body up to the neck</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Polyethylene wrap</intervention_name>
    <arm_group_label>Total body polyethylene wrap (body plus head)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Polyethylene wrap</intervention_name>
    <arm_group_label>Polyethylene wrap (body)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preterm infants &lt;29 weeks' gestation born in the study centers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and&#xD;
             babies whose delivery was not attended by the neonatal team&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>3 Minutes</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Padua, Azienda Ospedaliera di Padova</name>
      <address>
        <city>Padua</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniele Trevisanuto, MD</last_name>
      <phone>39 049 8213545</phone>
      <email>trevo@pediatria.unipd.it</email>
    </contact>
    <investigator>
      <last_name>Daniele Trevisanuto, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Vohra S, Roberts RS, Zhang B, Janes M, Schmidt B. Heat Loss Prevention (HeLP) in the delivery room: A randomized controlled trial of polyethylene occlusive skin wrapping in very preterm infants. J Pediatr. 2004 Dec;145(6):750-3. doi: 10.1016/j.jpeds.2004.07.036.</citation>
    <PMID>15580195</PMID>
  </reference>
  <reference>
    <citation>Vohra S, Frent G, Campbell V, Abbott M, Whyte R. Effect of polyethylene occlusive skin wrapping on heat loss in very low birth weight infants at delivery: a randomized trial. J Pediatr. 1999 May;134(5):547-51. doi: 10.1016/s0022-3476(99)70238-6.</citation>
    <PMID>10228287</PMID>
  </reference>
  <reference>
    <citation>Trevisanuto D, Doglioni N, Cavallin F, Parotto M, Micaglio M, Zanardo V. Heat loss prevention in very preterm infants in delivery rooms: a prospective, randomized, controlled trial of polyethylene caps. J Pediatr. 2010 Jun;156(6):914-917.e1. doi: 10.1016/j.jpeds.2009.12.021. Epub 2010 Mar 15.</citation>
    <PMID>20227728</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>August 22, 2012</last_update_submitted>
  <last_update_submitted_qc>August 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 23, 2012</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>Premature Birth</mesh_term>
    <mesh_term>Hypothermia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01671241
org study id: LossPreventionTotalBodyWrap
nct id: NCT01671241
lead sponsor: 
has dmc: Yes
Hypothermia after delivery is a world-wide problem associated with morbidity and mortality.
      The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is
      unsuccessful in a large proportion of very preterm infants. Polyethylene occlusive skin
      wrapping covering the infant's body up to the neck will reduce postnatal heat loss in very
      preterm babies and represents the standard of care recommended by the International
      Guidelines for Neonatal Resuscitation. The use of a polyethylene head cap will also reduce
      heat loss 9 and its efficacy is comparable to that obtained with the wrap. However, the
      proportions of hypothermic infants at NICU admission (temperature <34°C) in the wrapped group
      (62%) as well as in the infants covered with a polyethylene cap (43%) remain high. The
      combination of body and head protection with a polyethylene wrap needs to be evaluated
      further. The investigators conducted a prospective, randomized, controlled trial in very
      preterm infants to evaluate whether a polyethylene total body wrapping (body plus head)
      prevents heat loss after delivery better than polyethylene occlusive wrapping.
allocation: Randomized
primary purpose: Prevention
masking: None (Open Label)
measure: Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later
measure: Mortality prior to hospital discharge
measure: Major brain injury
measure: percentages of hyperthermic infants at NICU admission
arm group label: Total body polyethylene wrap (body plus head)
arm group type: Experimental
description: The entire body surface (body plus head) is covered by a polyethylene wrap
arm group label: Polyethylene wrap (body)
arm group type: Active Comparator
description: A polyethylene wrap covers the patient's body up to the neck
intervention type: Device
intervention name: Polyethylene wrap
arm group label: Total body polyethylene wrap (body plus head)
intervention type: Device
intervention name: Polyethylene wrap
arm group label: Polyethylene wrap (body)
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 3 Minutes
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
citation: Vohra S, Roberts RS, Zhang B, Janes M, Schmidt B. Heat Loss Prevention (HeLP) in the delivery room: A randomized controlled trial of polyethylene occlusive skin wrapping in very preterm infants. J Pediatr. 2004 Dec;145(6):750-3. doi: 10.1016/j.jpeds.2004.07.036.
PMID: 15580195
citation: Vohra S, Frent G, Campbell V, Abbott M, Whyte R. Effect of polyethylene occlusive skin wrapping on heat loss in very low birth weight infants at delivery: a randomized trial. J Pediatr. 1999 May;134(5):547-51. doi: 10.1016/s0022-3476(99)70238-6.
PMID: 10228287
citation: Trevisanuto D, Doglioni N, Cavallin F, Parotto M, Micaglio M, Zanardo V. Heat loss prevention in very preterm infants in delivery rooms: a prospective, randomized, controlled trial of polyethylene caps. J Pediatr. 2010 Jun;156(6):914-917.e1. doi: 10.1016/j.jpeds.2009.12.021. Epub 2010 Mar 15.
PMID: 20227728
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Hypothermia