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/NCT06002295</url>
    </required_header>
    <id_info>
      <org_study_id>SZMC/IRB/Internal/MD/130/19</org_study_id>
      <nct_id>NCT06002295</nct_id>
    </id_info>
    <brief_title>A Comparative Analysis of 4% Chlorhexidine Versus Methylated Spirit as Prophylaxis of Omphalitis and Sepsis in Newborns</brief_title>
    <official_title>A Comparative Analysis of 4% Chlorhexidine Versus Methylated Spirit as Prophylaxis of Omphalitis and Sepsis in Newborns</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sheikh Zayed Federal Postgraduate Medical Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sheikh Zayed Federal Postgraduate Medical Institute</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Introduction: Neonatal sepsis in one of the leading cause of death in developing countries.&#xD;
        Umbilical cord care is important as it may lead to infection. Topical treatment can help to&#xD;
        reduce the chances of infection as well as increase the chances of early removal. In this&#xD;
        regard methylated spirit and chlorhexidine are found to be effective.&#xD;
  &#xD;
        Aims and Objectives: To compare the effectiveness of 4% chlorhexidine and methylated spirit&#xD;
        in newborns for prevention of omphalitis and neonatal sepsis.&#xD;
  &#xD;
        Materials and Methods: This randomized control trial was carried out in neonatal unit of&#xD;
        Shaikh Zayed Hospital Lahore. After meeting the inclusion criteria, 300 neonates were&#xD;
        enrolled. In group A 4% chlorhexidine was applied for cord care and in group B methylated&#xD;
        spirit was used. Neonates were followed till 10th day of life. Careful examination was done&#xD;
        for cord separation and for any signs of omphalitis or sepsis. If the neonate had no signs&#xD;
        and symptoms of omphalitis and sepsis on 10th day of follow up then it was treatment success.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction:&#xD;
  &#xD;
        Neonatal sepsis in one of the leading causes of death in neonates in developing countries.&#xD;
        Infection of the umbilical cord often leads to infection in the blood. World Health&#xD;
        Organization (WHO) recommends 4% chlorhexidine to prevent omphalitis and neonatal sepsis. In&#xD;
        Pakistan the investigators use methylated spirit for prophylaxis of omphalitis as 4%&#xD;
        chlorhexidine is not available and expensive to use. Some commercial gels containing 2%&#xD;
        chlorhexidine is available, but these are not as effective as methylated spirit.&#xD;
  &#xD;
        Chlorhexidine gel is an antiseptic agent with broad-spectrum bactericidal and bacteriostatic&#xD;
        properties effective against gram-negative bacteria and fungi with rapid pathogen killing&#xD;
        rates. Methylated spirit on the other hand is both bactericidal, mycobactericidal,&#xD;
        fungicidal, and viricidal agent.&#xD;
  &#xD;
        In Pakistan Staphylococcal aureus is common pathogen in umbilical discharge. Some low cost&#xD;
        prevention therapy should be used. Methylated spirit is commonly used for cord care. A study&#xD;
        was conducted to explore about cord care practices in African setting which showed that 73.2%&#xD;
        respondents consider methylated spirit as most important agent for cord care.&#xD;
  &#xD;
        Chlorhexidine is available in different concentrations for antiseptic purpose. Efficacy of&#xD;
        all concentrations is comparable but 4% chlorhexidine concentration is more effective in&#xD;
        inhibiting organism's flora as compared to 2% chlorhexidine. Since then, multiple studies&#xD;
        were done to compare between methylated spirit and 4% chlorhexidine. Methylated spirit is&#xD;
        equally safe where 4% chlorhexidine is unavailable.&#xD;
  &#xD;
        In Pakistan 57% deaths occur in neonatal period. Pakistan has highest neonatal mortality rate&#xD;
        of 42 per 1000 live births. In developing countries neonatal sepsis is aggravated by home&#xD;
        deliveries, antibiotic resistance and less medical staff. The most important way to decrease&#xD;
        mortality and morbidity due to infections is prevention at an early stage. According to a&#xD;
        study conducted in Karachi, omphalitis is 217.4/1000 live births from which moderate-severe&#xD;
        omphalitis is 170/1000 live births and associated with sepsis is 20.4/1000 live births.&#xD;
        Various antiseptics used in neonatal intensive care units include chlorhexidine, alcohol,&#xD;
        iodine, hexachlorophene &amp; octenidine. Each agent having its own advantages and adverse&#xD;
        effects. However best antiseptic is yet to be determined.&#xD;
  &#xD;
        World Health Organization (WHO) recommends application for 4 percent chlorhexidine in high&#xD;
        neonatal mortality area and methylated spirit for cord care while methylated spirit is&#xD;
        commonly used agent for cord care. One study conducted shows that applying chlorhexidine on&#xD;
        cord in neonatal intensive care unit decreases mortality rate and decreases time of&#xD;
        separation of cord.&#xD;
  &#xD;
        Methylated spirit and chlorhexidine both have comparable efficacy and can be used in areas of&#xD;
        non-availability of chlorhexidine and whenever chlorhexidine is not safe to use as in very&#xD;
        preterm neonates. In Pakistan there is no population based study published on this issue this&#xD;
        study aimed to compare the effectiveness of methylated spirit and 4% chlorohexidine from&#xD;
        prevention of omphalitis and neonatal sepsis. This study will help to establish the use of&#xD;
        methylated spirit in prevention of omphalitis and neonatal sepsis at low price and easy&#xD;
        availability.&#xD;
  &#xD;
        Methodology:&#xD;
  &#xD;
        It was a randomized controlled trial done at the Neonatology unit, Department of Pediatrics,&#xD;
        Shaikh Zayed Hospital, Lahore. For a period of 12 months from September 2020 to September&#xD;
        2021 with the hypothesis that methylated spirit is equally effective as 4% chlorhexidine in&#xD;
        preventing omphalitis and sepsis in neonate. 300 newborns were included by probability&#xD;
        consecutive sampling in study with 150 newborns in each group with confidence interval of 95%&#xD;
        and margin of error 5%. Sample size was calculated using Raosoft sample size calculator.&#xD;
  &#xD;
        After approval from the hospital ethical committee, neonates fulfilling inclusion and&#xD;
        exclusion criteria were selected. Written informed consent was obtained from the parents.&#xD;
        Full instructions to avoid confounding variables like maintaining temperature and hygiene of&#xD;
        newborn, frequent diaper change, avoidance of herbal tonics and cow milk were given to&#xD;
        mothers.&#xD;
  &#xD;
        In group &quot;A&quot; mothers were advised the topical application of 4% chlorhexidine generously over&#xD;
        cord along with base of cord stump and surrounding skin thrice a day. In group &quot;B&quot; clean&#xD;
        cotton swab dipped in methylated spirit was used to clean cord along with cord clamps and&#xD;
        base thrice a day.&#xD;
  &#xD;
        Neonates were followed till 10th day of life and careful examination was done for cord&#xD;
        separation and any signs of omphalitis or sepsis. Primary outcome measure was omphalitis&#xD;
        which was characterized by local inflamed cord. Secondary outcome measure was sepsis which&#xD;
        was characterized by signs and symptoms such as fever, reluctance to feed, respiratory&#xD;
        difficulty, irritability. Treatment success was labelled if there was no evidence of&#xD;
        omphalitis or sepsis. If omphalitis or evidence of sepsis was present, the patient was&#xD;
        treated as per hospital protocol. Data was collected according to proforma.&#xD;
  &#xD;
        Statistical Analysis:&#xD;
  &#xD;
        Data was entered in SPSS v.23.0 and was analyzed through it. The numeric variables like&#xD;
        gestational age at birth and birth weight were presented as mean ± standard deviation, while&#xD;
        the categorical variables like gender of the neonate, omphalitis and sepsis were presented as&#xD;
        frequency (%). Both groups were compared for omphalitis and sepsis by using the chi-square&#xD;
        (ﬡ²) test. P-value ≤ 0.05 was kept as significant. Data was stratified for gender of the&#xD;
        neonate, gestational age at birth and birth weight to deal with the effect modifiers.&#xD;
        Post-stratification, Chi-Square test was applied to compare both groups for omphalitis and&#xD;
        sepsis in each strata. P-value ≤ 0.05 was kept as significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 12, 2020</start_date>
    <completion_date type="Actual">November 19, 2021</completion_date>
    <primary_completion_date type="Actual">September 22, 2021</primary_completion_date>
    <phase>Phase 2</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>Number of participants with Omphalitis</measure>
      <time_frame>10 days</time_frame>
      <description>Inflammation of the navel in newborn babies as assessed by redness and swelling of the area.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with Neonatal Sepsis</measure>
      <time_frame>10 days</time_frame>
      <description>It refers to an infection involving bloodstream in newborn infants less than 28 days old as assessed by following parameters: fever &gt;38.5 °, heart rate &gt;2SD for age, respiratory rate &gt;2SD for age, irritability, lethargic, cyanosis, poor perfusion, feeding difficulty, urine output &lt;0.5ml/kg/hr.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">300</enrollment>
    <condition>Neonatal Sepsis</condition>
    <condition>Omphalitis</condition>
    <arm_group>
      <arm_group_label>Umbilical Cord Care with Chlorhexidine (Group A)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Umbilical Cord Care with Methylated Spirit (Group B)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Chlorhexidine Topical Cream</intervention_name>
      <description>After approval from the hospital ethical committee, neonates fulfilling inclusion and exclusion criteria were selected. Written informed consent was obtained from the parents. Full instructions to avoid confounding variables like maintaining temperature and hygiene of newborn, frequent diaper change, avoidance of herbal tonics and cow milk; are given to mothers.&#xD;
  In group &quot;A&quot; 4% chlorhexidine was applied generously over cord along with base of cord stump and surrounding skin thrice a day. In group &quot;B&quot; clean cotton swab dipped in methylated spirit was used to clean cord along with cord clamps and base thrice a day.</description>
      <arm_group_label>Umbilical Cord Care with Chlorhexidine (Group A)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Methylated Spirit</intervention_name>
      <description>After approval from the hospital ethical committee, neonates fulfilling inclusion and exclusion criteria were selected. Written informed consent was obtained from the parents. Full instructions to avoid confounding variables like maintaining temperature and hygiene of newborn, frequent diaper change, avoidance of herbal tonics and cow milk; are given to mothers.&#xD;
  In group &quot;A&quot; 4% chlorhexidine was applied generously over cord along with base of cord stump and surrounding skin thrice a day. In group &quot;B&quot; clean cotton swab dipped in methylated spirit was used to clean cord along with cord clamps and base thrice a day.</description>
      <arm_group_label>Umbilical Cord Care with Methylated Spirit (Group B)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Term neonates of either gender born via cesarean section or spontaneous vaginal&#xD;
               delivery at Shaikh Zayed Hospital after taking informed consent of parents.&#xD;
  &#xD;
            -  Antiseptic agent started from 1st day of life &amp; up to 10 days continued without&#xD;
               missing dose&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Newborns with congenital defects or cord anomalies.&#xD;
  &#xD;
            -  Laboratory or clinical evidence of sepsis.&#xD;
  &#xD;
            -  Preterm newborns&#xD;
  &#xD;
            -  Newborns having very low birth weight &lt;1.5 kg&#xD;
  &#xD;
            -  Any evidence of asphyxia during birth.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Day</minimum_age>
      <maximum_age>10 Days</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Sheikh Zayed Federal Postgraduate Medical Institute</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>54500</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sheikh Zayed Federal Postgraduate Medical Institute</investigator_affiliation>
      <investigator_full_name>Ahmad Zunair Wasim</investigator_full_name>
      <investigator_title>Resident Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sepsis</mesh_term>
      <mesh_term>Toxemia</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>
    <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/NCT06002295
  org study id: SZMC/IRB/Internal/MD/130/19
  nct id: NCT06002295
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Introduction: Neonatal sepsis in one of the leading cause of death in developing countries.
        Umbilical cord care is important as it may lead to infection. Topical treatment can help to
        reduce the chances of infection as well as increase the chances of early removal. In this
        regard methylated spirit and chlorhexidine are found to be effective.
  
        Aims and Objectives: To compare the effectiveness of 4% chlorhexidine and methylated spirit
        in newborns for prevention of omphalitis and neonatal sepsis.
  
        Materials and Methods: This randomized control trial was carried out in neonatal unit of
        Shaikh Zayed Hospital Lahore. After meeting the inclusion criteria, 300 neonates were
        enrolled. In group A 4% chlorhexidine was applied for cord care and in group B methylated
        spirit was used. Neonates were followed till 10th day of life. Careful examination was done
        for cord separation and for any signs of omphalitis or sepsis. If the neonate had no signs
        and symptoms of omphalitis and sepsis on 10th day of follow up then it was treatment success.
  Introduction:
  
        Neonatal sepsis in one of the leading causes of death in neonates in developing countries.
        Infection of the umbilical cord often leads to infection in the blood. World Health
        Organization (WHO) recommends 4% chlorhexidine to prevent omphalitis and neonatal sepsis. In
        Pakistan the investigators use methylated spirit for prophylaxis of omphalitis as 4%
        chlorhexidine is not available and expensive to use. Some commercial gels containing 2%
        chlorhexidine is available, but these are not as effective as methylated spirit.
  
        Chlorhexidine gel is an antiseptic agent with broad-spectrum bactericidal and bacteriostatic
        properties effective against gram-negative bacteria and fungi with rapid pathogen killing
        rates. Methylated spirit on the other hand is both bactericidal, mycobactericidal,
        fungicidal, and viricidal agent.
  
        In Pakistan Staphylococcal aureus is common pathogen in umbilical discharge. Some low cost
        prevention therapy should be used. Methylated spirit is commonly used for cord care. A study
        was conducted to explore about cord care practices in African setting which showed that 73.2%
        respondents consider methylated spirit as most important agent for cord care.
  
        Chlorhexidine is available in different concentrations for antiseptic purpose. Efficacy of
        all concentrations is comparable but 4% chlorhexidine concentration is more effective in
        inhibiting organism's flora as compared to 2% chlorhexidine. Since then, multiple studies
        were done to compare between methylated spirit and 4% chlorhexidine. Methylated spirit is
        equally safe where 4% chlorhexidine is unavailable.
  
        In Pakistan 57% deaths occur in neonatal period. Pakistan has highest neonatal mortality rate
        of 42 per 1000 live births. In developing countries neonatal sepsis is aggravated by home
        deliveries, antibiotic resistance and less medical staff. The most important way to decrease
        mortality and morbidity due to infections is prevention at an early stage. According to a
        study conducted in Karachi, omphalitis is 217.4/1000 live births from which moderate-severe
        omphalitis is 170/1000 live births and associated with sepsis is 20.4/1000 live births.
        Various antiseptics used in neonatal intensive care units include chlorhexidine, alcohol,
        iodine, hexachlorophene & octenidine. Each agent having its own advantages and adverse
        effects. However best antiseptic is yet to be determined.
  
        World Health Organization (WHO) recommends application for 4 percent chlorhexidine in high
        neonatal mortality area and methylated spirit for cord care while methylated spirit is
        commonly used agent for cord care. One study conducted shows that applying chlorhexidine on
        cord in neonatal intensive care unit decreases mortality rate and decreases time of
        separation of cord.
  
        Methylated spirit and chlorhexidine both have comparable efficacy and can be used in areas of
        non-availability of chlorhexidine and whenever chlorhexidine is not safe to use as in very
        preterm neonates. In Pakistan there is no population based study published on this issue this
        study aimed to compare the effectiveness of methylated spirit and 4% chlorohexidine from
        prevention of omphalitis and neonatal sepsis. This study will help to establish the use of
        methylated spirit in prevention of omphalitis and neonatal sepsis at low price and easy
        availability.
  
        Methodology:
  
        It was a randomized controlled trial done at the Neonatology unit, Department of Pediatrics,
        Shaikh Zayed Hospital, Lahore. For a period of 12 months from September 2020 to September
        2021 with the hypothesis that methylated spirit is equally effective as 4% chlorhexidine in
        preventing omphalitis and sepsis in neonate. 300 newborns were included by probability
        consecutive sampling in study with 150 newborns in each group with confidence interval of 95%
        and margin of error 5%. Sample size was calculated using Raosoft sample size calculator.
  
        After approval from the hospital ethical committee, neonates fulfilling inclusion and
        exclusion criteria were selected. Written informed consent was obtained from the parents.
        Full instructions to avoid confounding variables like maintaining temperature and hygiene of
        newborn, frequent diaper change, avoidance of herbal tonics and cow milk were given to
        mothers.
  
        In group "A" mothers were advised the topical application of 4% chlorhexidine generously over
        cord along with base of cord stump and surrounding skin thrice a day. In group "B" clean
        cotton swab dipped in methylated spirit was used to clean cord along with cord clamps and
        base thrice a day.
  
        Neonates were followed till 10th day of life and careful examination was done for cord
        separation and any signs of omphalitis or sepsis. Primary outcome measure was omphalitis
        which was characterized by local inflamed cord. Secondary outcome measure was sepsis which
        was characterized by signs and symptoms such as fever, reluctance to feed, respiratory
        difficulty, irritability. Treatment success was labelled if there was no evidence of
        omphalitis or sepsis. If omphalitis or evidence of sepsis was present, the patient was
        treated as per hospital protocol. Data was collected according to proforma.
  
        Statistical Analysis:
  
        Data was entered in SPSS v.23.0 and was analyzed through it. The numeric variables like
        gestational age at birth and birth weight were presented as mean ± standard deviation, while
        the categorical variables like gender of the neonate, omphalitis and sepsis were presented as
        frequency (%). Both groups were compared for omphalitis and sepsis by using the chi-square
        (ﬡ²) test. P-value ≤ 0.05 was kept as significant. Data was stratified for gender of the
        neonate, gestational age at birth and birth weight to deal with the effect modifiers.
        Post-stratification, Chi-Square test was applied to compare both groups for omphalitis and
        sepsis in each strata. P-value ≤ 0.05 was kept as significant.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of participants with Omphalitis
  time frame: 10 days
  description: Inflammation of the navel in newborn babies as assessed by redness and swelling of the area.
  measure: Number of participants with Neonatal Sepsis
  time frame: 10 days
  description: It refers to an infection involving bloodstream in newborn infants less than 28 days old as assessed by following parameters: fever >38.5 °, heart rate >2SD for age, respiratory rate >2SD for age, irritability, lethargic, cyanosis, poor perfusion, feeding difficulty, urine output <0.5ml/kg/hr.
  arm group label: Umbilical Cord Care with Chlorhexidine (Group A)
  arm group type: Experimental
  arm group label: Umbilical Cord Care with Methylated Spirit (Group B)
  arm group type: Experimental
  intervention type: Drug
  intervention name: Chlorhexidine Topical Cream
  description: After approval from the hospital ethical committee, neonates fulfilling inclusion and exclusion criteria were selected. Written informed consent was obtained from the parents. Full instructions to avoid confounding variables like maintaining temperature and hygiene of newborn, frequent diaper change, avoidance of herbal tonics and cow milk; are given to mothers.
  In group "A" 4% chlorhexidine was applied generously over cord along with base of cord stump and surrounding skin thrice a day. In group "B" clean cotton swab dipped in methylated spirit was used to clean cord along with cord clamps and base thrice a day.
  arm group label: Umbilical Cord Care with Chlorhexidine (Group A)
  intervention type: Drug
  intervention name: Methylated Spirit
  description: After approval from the hospital ethical committee, neonates fulfilling inclusion and exclusion criteria were selected. Written informed consent was obtained from the parents. Full instructions to avoid confounding variables like maintaining temperature and hygiene of newborn, frequent diaper change, avoidance of herbal tonics and cow milk; are given to mothers.
  In group "A" 4% chlorhexidine was applied generously over cord along with base of cord stump and surrounding skin thrice a day. In group "B" clean cotton swab dipped in methylated spirit was used to clean cord along with cord clamps and base thrice a day.
  arm group label: Umbilical Cord Care with Methylated Spirit (Group B)
  criteria: 
  gender: All
  minimum age: 1 Day
  maximum age: 10 Days
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Sheikh Zayed Federal Postgraduate Medical Institute
  investigator full name: Ahmad Zunair Wasim
  investigator title: Resident Doctor
  mesh term: Sepsis
  mesh term: Toxemia
  mesh term: Neonatal Sepsis
  mesh term: Chlorhexidine
  sharing ipd: No