<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/NCT02250079</url>
  </required_header>
  <id_info>
    <org_study_id>polyethylene29</org_study_id>
    <nct_id>NCT02250079</nct_id>
  </id_info>
  <brief_title>Polyethylene Body Bags as an Alternative to Radiant Heat Lamp During the Neonatal Adaptation in Infants Older Than 29 Weeks</brief_title>
  <official_title>Features and Differences Between Neonates Undergoing Body Bag With Polyethylene and Conventional Drying During Neonatal Adaptation in Maternal and Child Headquarters Hospital and the Victoria Hospital Engativá, Bogotá, 2013</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Nacional de Colombia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Nacional de Colombia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      INTRODUCTION: Hypothermia in the newborn causes morbid conditions. In developing countries in&#xD;
      the basic technology for neonatal adaptation may not be available. Polyethylene bags may be&#xD;
      an alternative to lamp radiant heat to prevent hypothermia OBJECTIVE: To characterize the&#xD;
      differences between babies undergoing body bag with polyethylene or conventional drying&#xD;
      during neonatal adaptation in the Hospital de la Victoria and Hospital de Engativá, Bogotá,&#xD;
      Colombia, 2013.&#xD;
&#xD;
      MATERIALS AND METHODS: parallel-group randomized controlled trial. Groups: dried conventional&#xD;
      (control) or polyethylene body bag (intervention). The procedure lasted 10 minutes, the bag&#xD;
      body and / or radiant heat lamp was removed. Environment temperature and humidity,&#xD;
      temperature in the body segments 1-5-10-60-120 minutes and APGAR was measured. Statistical&#xD;
      Analysis: Descriptive bivariate statistical inference and calculated. Risk ratio (RR) and&#xD;
      confidence intervals (CIs) were determined using contingency tables for risk analysis of the&#xD;
      outcome. The study was approved by the hospital ethics committee of victory.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Temperature</measure>
    <time_frame>10 minutes</time_frame>
    <description>The Student's t test and U of Mann Whitney were used to compare temperature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Humidity</measure>
    <time_frame>10 minutes</time_frame>
    <description>The Student's t test and U of Mann Whitney were used to compare relative humidity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Both, Hypothermia or Hyperthermia</measure>
    <time_frame>10 minutes</time_frame>
    <description>Risk ratio (RR) and confidence intervals (CIs) were determined using contingency tables for risk analysis of hypothermia, hyperthermia and APGAR.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Baseline Charasteristics</measure>
    <time_frame>10 minutes</time_frame>
    <description>The baseline characteristics of each group were compared using descriptive statistics. The Student's t test and x2 were used to compare continuous and categorical variables, respectively. Fisher's exact test was used for events with low prevalence.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Neonatal Adaptation</condition>
  <arm_group>
    <arm_group_label>Polyethilene body bag group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group infants were provided the same care as control infants, but were dressed with the polyethylene body bag immediately after birth. The bag had an upper opening for the head and a seal at the bottom. The intervention group infants remained in the plastic bag for the first 10 minutes after birth. The same process was done in surgery room in case of cesarean. Umbilical prophylaxis, vitamin K1 application, initial physical examination and ocular prophylaxis are performed. The infants were swaddled in blankets provided by the mother, the head was covered with a hat, and the infants were placed either in an open crib or under a radiant warmer as necessary and available. The same process were done in surgery room in case of cesarean</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>): Infants randomized to the control group received standard hospital care newborn. This included immediate drying, skin-to-skin contact, early and exclusive breast feeding, postponed bathing, bundling, and radiant warmer. While waiting for criteria cord clamping, the environment humidity and temperature and segment and rectal temperature of the newborn were measure. It was repeated at 1-5- 10-60 and 120 minutes. After clamping, the newborn were positioned in a radiant warmer, and completed the drying process. Umbilical prophylaxis, vitamin K1 application, initial physical examination and ocular prophylaxis are performed. The infants were swaddled in blankets provided by the mother, the head was covered with a hat, and the infants were placed either in an open crib or under a radiant warmer as necessary and available. The same process was done in surgery room in case of cesarean.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>polyethylene plastic bag</intervention_name>
    <description>Inborn neonates with both a gestational age &gt;29 weeks were randomized 1:1 to either a standard thermoregulation protocol or placement of a Poliethylene body bag since birth to 10 minutes after birth.</description>
    <arm_group_label>Polyethilene body bag group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional treatment</intervention_name>
    <description>Infants randomized to the control group received standard hospital care newborn. This included immediate drying, skin-to-skin contact, early and exclusive breast feeding, postponed bathing, bundling, and radiant warmer. While waiting for criteria cord clamping, the environment humidity and temperature and segment and rectal temperature of the newborn were measure. It was repeated at 1-5- 10-60 and 120 minutes. After clamping, the newborn were positioned in a radiant warmer, and completed the drying process. Umbilical prophylaxis, vitamin K1 application, initial physical examination and ocular prophylaxis are performed. The infants were swaddled in blankets provided by the mother, the head was covered with a hat, and the infants were placed either in an open crib or under a radiant warmer as necessary and available. The same process was done in surgery room in case of cesarean.</description>
    <arm_group_label>Conventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inborn neonates with both a gestational age &gt;29 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abdominal wall defect, myelomeningocele, major congenital anomaly, or blistering skin&#xD;
             disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>29 Weeks</minimum_age>
    <maximum_age>42 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital de la Victoria</name>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 23, 2014</last_update_submitted>
  <last_update_submitted_qc>September 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02250079
org study id: polyethylene29
nct id: NCT02250079
lead sponsor: 
has dmc: Yes
INTRODUCTION: Hypothermia in the newborn causes morbid conditions. In developing countries in
      the basic technology for neonatal adaptation may not be available. Polyethylene bags may be
      an alternative to lamp radiant heat to prevent hypothermia OBJECTIVE: To characterize the
      differences between babies undergoing body bag with polyethylene or conventional drying
      during neonatal adaptation in the Hospital de la Victoria and Hospital de Engativá, Bogotá,
      Colombia, 2013.

      MATERIALS AND METHODS: parallel-group randomized controlled trial. Groups: dried conventional
      (control) or polyethylene body bag (intervention). The procedure lasted 10 minutes, the bag
      body and / or radiant heat lamp was removed. Environment temperature and humidity,
      temperature in the body segments 1-5-10-60-120 minutes and APGAR was measured. Statistical
      Analysis: Descriptive bivariate statistical inference and calculated. Risk ratio (RR) and
      confidence intervals (CIs) were determined using contingency tables for risk analysis of the
      outcome. The study was approved by the hospital ethics committee of victory.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Temperature
time frame: 10 minutes
description: The Student's t test and U of Mann Whitney were used to compare temperature
measure: Humidity
time frame: 10 minutes
description: The Student's t test and U of Mann Whitney were used to compare relative humidity.
measure: Both, Hypothermia or Hyperthermia
time frame: 10 minutes
description: Risk ratio (RR) and confidence intervals (CIs) were determined using contingency tables for risk analysis of hypothermia, hyperthermia and APGAR.
measure: Baseline Charasteristics
time frame: 10 minutes
description: The baseline characteristics of each group were compared using descriptive statistics. The Student's t test and x2 were used to compare continuous and categorical variables, respectively. Fisher's exact test was used for events with low prevalence.
arm group label: Polyethilene body bag group
arm group type: Experimental
description: The intervention group infants were provided the same care as control infants, but were dressed with the polyethylene body bag immediately after birth. The bag had an upper opening for the head and a seal at the bottom. The intervention group infants remained in the plastic bag for the first 10 minutes after birth. The same process was done in surgery room in case of cesarean. Umbilical prophylaxis, vitamin K1 application, initial physical examination and ocular prophylaxis are performed. The infants were swaddled in blankets provided by the mother, the head was covered with a hat, and the infants were placed either in an open crib or under a radiant warmer as necessary and available. The same process were done in surgery room in case of cesarean
arm group label: Conventional group
arm group type: Active Comparator
description: ): Infants randomized to the control group received standard hospital care newborn. This included immediate drying, skin-to-skin contact, early and exclusive breast feeding, postponed bathing, bundling, and radiant warmer. While waiting for criteria cord clamping, the environment humidity and temperature and segment and rectal temperature of the newborn were measure. It was repeated at 1-5- 10-60 and 120 minutes. After clamping, the newborn were positioned in a radiant warmer, and completed the drying process. Umbilical prophylaxis, vitamin K1 application, initial physical examination and ocular prophylaxis are performed. The infants were swaddled in blankets provided by the mother, the head was covered with a hat, and the infants were placed either in an open crib or under a radiant warmer as necessary and available. The same process was done in surgery room in case of cesarean.
intervention type: Device
intervention name: polyethylene plastic bag
description: Inborn neonates with both a gestational age >29 weeks were randomized 1:1 to either a standard thermoregulation protocol or placement of a Poliethylene body bag since birth to 10 minutes after birth.
arm group label: Polyethilene body bag group
intervention type: Device
intervention name: Conventional treatment
description: Infants randomized to the control group received standard hospital care newborn. This included immediate drying, skin-to-skin contact, early and exclusive breast feeding, postponed bathing, bundling, and radiant warmer. While waiting for criteria cord clamping, the environment humidity and temperature and segment and rectal temperature of the newborn were measure. It was repeated at 1-5- 10-60 and 120 minutes. After clamping, the newborn were positioned in a radiant warmer, and completed the drying process. Umbilical prophylaxis, vitamin K1 application, initial physical examination and ocular prophylaxis are performed. The infants were swaddled in blankets provided by the mother, the head was covered with a hat, and the infants were placed either in an open crib or under a radiant warmer as necessary and available. The same process was done in surgery room in case of cesarean.
arm group label: Conventional group
criteria: 
gender: All
minimum age: 29 Weeks
maximum age: 42 Weeks
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Colombia
responsible party type: Sponsor