<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/NCT01723501</url>
  </required_header>
  <id_info>
    <org_study_id>NHKC-Chx2012</org_study_id>
    <nct_id>NCT01723501</nct_id>
  </id_info>
  <brief_title>Chlorhexidine Skin Application for Prevention of Infection in Infants Weighing &lt;1500 g at Birth</brief_title>
  <acronym>CAPS</acronym>
  <official_title>Whole Body Cleansing With 0.25% Chlorhexidine at Birth for Prevention of Sepsis in Infants &lt;1500 g: a Multi-center, Blinded, Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>All India Institute of Medical Sciences, New Delhi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maulana Azad Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vardhman Mahavir Medical College And Safdarjung Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>All India Institute of Medical Sciences, New Delhi</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of this study is determine if skin application of chlorhexidine at birth would reduce&#xD;
      infection in infants weighing &lt;1500 g at birth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      Infants weighing &lt;1500 g at birth infants are more prone to acquire infections, often through&#xD;
      their immature skin which serve as a portal of entry for invasive pathogens. Skin application&#xD;
      of antiseptics such as chlorhexidine may reduce infections in these infants. However, there&#xD;
      is a paucity of data on the safety and efficacy of such intervention in these infants.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Among hospitalized very low birth weight (VLBW; &lt;1500 g) neonates, single whole body skin&#xD;
      cleansing with 0.25% chlorhexidine within 6 hours after birth would reduce the incidence of&#xD;
      sepsis in the first seven days of life from 25% to 17.5% (relative reduction of 30%) when&#xD;
      compared to skin cleansing with sterile water&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary- To evaluate the effect of whole body skin cleansing with 0.25% chlorhexidine (single&#xD;
      application, at birth) on the incidence of sepsis (culture positive or culture negative)&#xD;
      compared to sterile water cleansing in the first week of life in VLBW infants&#xD;
&#xD;
      Secondary- to compare following outcomes in this experiment:&#xD;
&#xD;
        1. Culture-confirmed sepsis within the first week of life&#xD;
&#xD;
        2. Need for repeat hospital admissions within first 28 days of life&#xD;
&#xD;
        3. Mortality within first 28 days of life&#xD;
&#xD;
        4. Cold stress/hypothermia at 0, 5, 15 and 30 minutes of intervention&#xD;
&#xD;
        5. Skin condition at 24 h of life&#xD;
&#xD;
        6. Colonization rates (subset)&#xD;
&#xD;
        7. Serum levels of chlorhexidine (subset)&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Eligible infants would be randomized within 6 hours of birth to either whole body skin&#xD;
      cleansing with chlorhexidine (specially prepared wipes releasing 0.25% chlorhexidine), or&#xD;
      sterile water (placebo). The research staff would collect the baseline data, record the&#xD;
      axillary temperature and assess the skin condition using the Newborn Skin Condition Scoring&#xD;
      (NSCS)score. The research team would follow the infants for development of sepsis and other&#xD;
      outcomes. The infants would be subjected to detailed sepsis work up on clinical suspicion of&#xD;
      sepsis, until 28 days of life.&#xD;
&#xD;
      Sepsis would be defined based on combination of clinical course, indirect markers, bacterial&#xD;
      culture results and antibiotic treatment status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study was not started and prematurely closed.&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <phase>Phase 2/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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sepsis within first 7 days of life</measure>
    <time_frame>First 7 days of life</time_frame>
    <description>Sepsis would be defined on the basis of clinical course, lab parameters including culture results and antibiotic treatment given.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readmissions &amp; mortality rates within neonatal period</measure>
    <time_frame>28 days</time_frame>
    <description>The re-admissions &amp; mortality rates within neonatal period in these infants will be prospectively recorded during hospital admission as well as follow up. The follow up includes telephonic contact as well as home visits and verbal autopsy in cases of deaths at home.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body temperature at 0, 5, 15, 30 minutes after application</measure>
    <time_frame>30 minutes</time_frame>
    <description>Axillary temperature would be monitored with thermometer at above time points for full three minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin condition</measure>
    <time_frame>24 ±6 hours</time_frame>
    <description>Newborn Skin Condition Score (NSCS)will be used to assess the skin condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin colonization rates</measure>
    <time_frame>24 ±6 hours</time_frame>
    <description>In a sub-group of infants, skin swabs will be collected at baseline and 24 ±6 hours and sent to microbiology lab; colonization rates would be determined by semi-quantitative methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chlorhexidine percutaneous absorption</measure>
    <time_frame>48 ±6 hours</time_frame>
    <description>Serum chlorhexidine levels will be assayed in a sub-set to assess the extent of percutaneous absorption. 5ml of blood will be stored at -80 deg. C till transport to the lab. Samples will be processed in batches as per standard protocol to determine the levels.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Neonatal Sepsis</condition>
  <condition>Neonatal Mortality Rate</condition>
  <arm_group>
    <arm_group_label>sterile water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>sterile water wipes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.25% chlorhexidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.44% chlorhexidine digluconate wipes which will release 0.25% free chlorhexidine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.25% chlorhexidine</intervention_name>
    <description>0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application</description>
    <arm_group_label>0.25% chlorhexidine</arm_group_label>
    <other_name>Chx</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sterile water</intervention_name>
    <description>Sterile water wipes (placebo)</description>
    <arm_group_label>sterile water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Birth weight less than 1500 g&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Birth weight &lt;750 g&#xD;
&#xD;
          -  Major congenital malformations&#xD;
&#xD;
          -  Total duration of positive pressure ventilation (PPV) &gt; 3 mins OR chest compressions&#xD;
&#xD;
          -  Shock- requiring inotropes &gt;10 mic/kg/min&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vinod K Paul, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>All India Institute of Medical Sciences, New Delhi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maulana Azad Medical College</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>All India Institute of Medical Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vardhman Medical College and Safdarjung Hospital</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>http://www.newbornwhocc.org</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>July 15, 2016</last_update_submitted>
  <last_update_submitted_qc>July 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>All India Institute of Medical Sciences, New Delhi</investigator_affiliation>
    <investigator_full_name>Dr Vinod K Paul</investigator_full_name>
    <investigator_title>Professor &amp; Head, Department of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>chlorhexidine</keyword>
  <keyword>sepsis</keyword>
  <keyword>neonatal</keyword>
  <keyword>whole-body skin cleansing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Neonatal Sepsis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
  </intervention_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/NCT01723501
org study id: NHKC-Chx2012
nct id: NCT01723501
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Purpose of this study is determine if skin application of chlorhexidine at birth would reduce
      infection in infants weighing <1500 g at birth.
Background

      Infants weighing <1500 g at birth infants are more prone to acquire infections, often through
      their immature skin which serve as a portal of entry for invasive pathogens. Skin application
      of antiseptics such as chlorhexidine may reduce infections in these infants. However, there
      is a paucity of data on the safety and efficacy of such intervention in these infants.

      Hypothesis:

      Among hospitalized very low birth weight (VLBW; <1500 g) neonates, single whole body skin
      cleansing with 0.25% chlorhexidine within 6 hours after birth would reduce the incidence of
      sepsis in the first seven days of life from 25% to 17.5% (relative reduction of 30%) when
      compared to skin cleansing with sterile water

      Objectives:

      Primary- To evaluate the effect of whole body skin cleansing with 0.25% chlorhexidine (single
      application, at birth) on the incidence of sepsis (culture positive or culture negative)
      compared to sterile water cleansing in the first week of life in VLBW infants

      Secondary- to compare following outcomes in this experiment:

        1. Culture-confirmed sepsis within the first week of life

        2. Need for repeat hospital admissions within first 28 days of life

        3. Mortality within first 28 days of life

        4. Cold stress/hypothermia at 0, 5, 15 and 30 minutes of intervention

        5. Skin condition at 24 h of life

        6. Colonization rates (subset)

        7. Serum levels of chlorhexidine (subset)

      Methods:

      Eligible infants would be randomized within 6 hours of birth to either whole body skin
      cleansing with chlorhexidine (specially prepared wipes releasing 0.25% chlorhexidine), or
      sterile water (placebo). The research staff would collect the baseline data, record the
      axillary temperature and assess the skin condition using the Newborn Skin Condition Scoring
      (NSCS)score. The research team would follow the infants for development of sepsis and other
      outcomes. The infants would be subjected to detailed sepsis work up on clinical suspicion of
      sepsis, until 28 days of life.

      Sepsis would be defined based on combination of clinical course, indirect markers, bacterial
      culture results and antibiotic treatment status.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Sepsis within first 7 days of life
time frame: First 7 days of life
description: Sepsis would be defined on the basis of clinical course, lab parameters including culture results and antibiotic treatment given.
measure: Readmissions & mortality rates within neonatal period
time frame: 28 days
description: The re-admissions & mortality rates within neonatal period in these infants will be prospectively recorded during hospital admission as well as follow up. The follow up includes telephonic contact as well as home visits and verbal autopsy in cases of deaths at home.
measure: Body temperature at 0, 5, 15, 30 minutes after application
time frame: 30 minutes
description: Axillary temperature would be monitored with thermometer at above time points for full three minutes.
measure: Skin condition
time frame: 24 ±6 hours
description: Newborn Skin Condition Score (NSCS)will be used to assess the skin condition.
measure: Skin colonization rates
time frame: 24 ±6 hours
description: In a sub-group of infants, skin swabs will be collected at baseline and 24 ±6 hours and sent to microbiology lab; colonization rates would be determined by semi-quantitative methods.
measure: Chlorhexidine percutaneous absorption
time frame: 48 ±6 hours
description: Serum chlorhexidine levels will be assayed in a sub-set to assess the extent of percutaneous absorption. 5ml of blood will be stored at -80 deg. C till transport to the lab. Samples will be processed in batches as per standard protocol to determine the levels.
arm group label: sterile water
arm group type: Placebo Comparator
description: sterile water wipes
arm group label: 0.25% chlorhexidine
arm group type: Experimental
description: 0.44% chlorhexidine digluconate wipes which will release 0.25% free chlorhexidine
intervention type: Drug
intervention name: 0.25% chlorhexidine
description: 0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application
arm group label: 0.25% chlorhexidine
other name: Chx
intervention type: Drug
intervention name: sterile water
description: Sterile water wipes (placebo)
arm group label: sterile water
criteria: 
gender: All
minimum age: N/A
maximum age: 28 Days
healthy volunteers: No
last name: Vinod K Paul, MD, PhD
role: Principal Investigator
affiliation: All India Institute of Medical Sciences, New Delhi
facility: 
facility: 
facility: 
country: India
url: http://www.newbornwhocc.org
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: All India Institute of Medical Sciences, New Delhi
investigator full name: Dr Vinod K Paul
investigator title: Professor & Head, Department of Pediatrics
mesh term: Sepsis
mesh term: Neonatal Sepsis
mesh term: Chlorhexidine