<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/NCT04401696</url>
  </required_header>
  <id_info>
    <org_study_id>BubbleCPAP</org_study_id>
    <nct_id>NCT04401696</nct_id>
  </id_info>
  <brief_title>Effectiveness of Bubble Nasal Continuous Positive Airway Pressure (bCPAP) in Neonatal Respiratory Distress</brief_title>
  <acronym>bCPAP</acronym>
  <official_title>Comparison of Bubble Nasal Continuous Positive Airway Pressure (bCPAP) Versus Control in Neonates With Respiratory Distress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Edward Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Edward Medical University</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>
      The objective of study is to determine the effectiveness of bubble Continuous Positive Airway&#xD;
      Pressure (bCPAP) in neonates presenting with respiratory distress as compared to the control&#xD;
      group ( using oxygen via nasal cannula). The effectiveness will be calculated in terms of&#xD;
      reduction in Silverman Anderson Retraction Score.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approval from the IRB of King Edward Medical University, and taking informed consent&#xD;
      from parents of the participants, total of 120 neonates fulfilling inclusion and exclusion&#xD;
      criteria will be enrolled and randomly allocated in two groups; group A and group B. All&#xD;
      demographic details of participants in both groups be collected. In group A, neonates will be&#xD;
      given bCPAP for respiratory support while neonates in group B, will be given nasal oxygen as&#xD;
      control group. Neonates in both groups will be followed for 48 hours. The effectiveness will&#xD;
      be determined by the reduction in Silverman Anderson Retraction Score (SARS) up to or less&#xD;
      than 3, at the end of 48 hours. Data will be collected and analysed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>N/A</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>Effectiveness of Bubble CPAP determined by improvement in Silvermann Anderson Retraction Score</measure>
    <time_frame>48 hours since application of intervention</time_frame>
    <description>Neonates in both groups will be followed-up for 48 hours. SAR Score will be recorded at 0 and 48 hours. It consists of five components: (1) chest retractions (2) retraction of the lower intercostal muscles (3) xiphoid retractions (4) flaring of nares with inhalation (5) grunting on exhalation. Each of the five factors is graded 0, 1 and 2. The sum of these factors yields the total score; minimum score is '0' and maximum score is '10'. The higher the score, the greater is the severity of respiratory distress. So the severity of respiratory distress can be graded according to the SAR Score as Mild (score 0-3), Moderate (score4-6) and Severe (score 6-10). Effectiveness is recorded as 'positive' in case of reduction in SARS score ≤3. A cut-off of score '3' is taken. So if the score of 3 or less than 3 is achieved with bCPAP or with nasal oxygen after 48 hours of intervention, the intervention is considered to be effective</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean reduction in SAR Score</measure>
    <time_frame>48 hours</time_frame>
    <description>Mean reduction in Silverman Anderson Retraction Score, over a period of 48 hours, in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in mean reduction</measure>
    <time_frame>48 hours</time_frame>
    <description>difference between both the groups, will also be calculated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Neonatal Respiratory Distress</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of Bubble CPAP for management of respiratory distress</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of Oxygen via nasal cannula for respiratory distress</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bubble CPAP</intervention_name>
    <description>The bCPAP will be delivered using an oxygen flow meter as the oxygen source. This inspiratory limb containing oxygen from the flow meter will be connected to humidifier and tubing from humidifier will be connected to short binasal prongs, which would be applied to neonate with the help of adhesive bandage on both cheeks. It will be ensured that binasal prongs make appropriate seal. An orogastric tube will be placed for gastric decompression. A 1000 ml/500ml bottle filled with sterile water be used and marks will be made on it at 1cm distance, with '10' marked at base and '0' mark at the water interface.&#xD;
The expiratory limb from the nasal prongs was connected to tubing that will be dipped in water up to the desired level to provide positive end expiratory pressure. Pressure is varied by varying the depth of the dipped end of tubing.</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nasal Oxygen</intervention_name>
    <description>The oxygen will be delivered from a wall oxygen source, delivered between 1 to 6 L/min and the rate varied via a flow regulator.</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients having age 28 days of life or younger (Neonates)&#xD;
&#xD;
          -  Gender- both male and female&#xD;
&#xD;
          -  Gestational ages ≥32 weeks&#xD;
&#xD;
          -  Having respiratory distress (as per the operational definition- respiratory rate&#xD;
             &gt;60/min plus any of the following features: grunting, subcostal/intercostal&#xD;
             retractions, nasal flaring, inability to maintain spO2 &gt;90% at room air)&#xD;
&#xD;
          -  Silverman Anderson Retraction Score ≥4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neonates having gestational age less than 32 weeks&#xD;
&#xD;
          -  Birth weight less than 1.5 kg&#xD;
&#xD;
          -  Neonates having congenital malformations, air leak syndromes, hypoxic ischemic&#xD;
             encephalopathy&#xD;
&#xD;
          -  Neonates requiring mechanical ventilation at the time of admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Hour</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tehreem Fatima, FCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Edward Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>King Edward Medical University/ Mayo Hospital Lahore</name>
      <address>
        <city>Lahore</city>
        <state>Punjab</state>
        <zip>54000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>Chen A, Deshmukh AA, Richards-Kortum R, Molyneux E, Kawaza K, Cantor SB. Cost-effectiveness analysis of a low-cost bubble CPAP device in providing ventilatory support for neonates in Malawi - a preliminary report. BMC Pediatr. 2014 Nov 25;14:288. doi: 10.1186/s12887-014-0288-1.</citation>
    <PMID>25421903</PMID>
  </reference>
  <reference>
    <citation>Mustufa MA, Korejo R, Shahid A, Nasim S. Infection remains a leading cause of neonatal mortality among infants delivered at a tertiary hospital in Karachi, Pakistan. J Infect Dev Ctries. 2014 Sep 13;8(11):1470-5. doi: 10.3855/jidc.3569.</citation>
    <PMID>25390060</PMID>
  </reference>
  <reference>
    <citation>Daga S, Mhatre S, Borhade A, Khan D. Home-made continuous positive airways pressure device may reduce mortality in neonates with respiratory distress in low-resource setting. J Trop Pediatr. 2014 Oct;60(5):343-7. doi: 10.1093/tropej/fmu023. Epub 2014 Apr 23.</citation>
    <PMID>24760748</PMID>
  </reference>
  <reference>
    <citation>Kawaza K, Machen HE, Brown J, Mwanza Z, Iniguez S, Gest A, Smith EO, Oden M, Richards-Kortum RR, Molyneux E. Efficacy of a low-cost bubble CPAP system in treatment of respiratory distress in a neonatal ward in Malawi. PLoS One. 2014 Jan 29;9(1):e86327. doi: 10.1371/journal.pone.0086327. eCollection 2014.</citation>
    <PMID>24489715</PMID>
  </reference>
  <reference>
    <citation>Brown J, Machen H, Kawaza K, Mwanza Z, Iniguez S, Lang H, Gest A, Kennedy N, Miros R, Richards-Kortum R, Molyneux E, Oden M. A high-value, low-cost bubble continuous positive airway pressure system for low-resource settings: technical assessment and initial case reports. PLoS One. 2013;8(1):e53622. doi: 10.1371/journal.pone.0053622. Epub 2013 Jan 23.</citation>
    <PMID>23372661</PMID>
  </reference>
  <reference>
    <citation>Stoll BJ, Hansen NI, Bell EF, Walsh MC, Carlo WA, Shankaran S, Laptook AR, Sanchez PJ, Van Meurs KP, Wyckoff M, Das A, Hale EC, Ball MB, Newman NS, Schibler K, Poindexter BB, Kennedy KA, Cotten CM, Watterberg KL, D'Angio CT, DeMauro SB, Truog WE, Devaskar U, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012. JAMA. 2015 Sep 8;314(10):1039-51. doi: 10.1001/jama.2015.10244.</citation>
    <PMID>26348753</PMID>
  </reference>
  <reference>
    <citation>Hundalani SG, Richards-Kortum R, Oden M, Kawaza K, Gest A, Molyneux E. Development and validation of a simple algorithm for initiation of CPAP in neonates with respiratory distress in Malawi. Arch Dis Child Fetal Neonatal Ed. 2015 Jul;100(4):F332-6. doi: 10.1136/archdischild-2014-308082. Epub 2015 Apr 15.</citation>
    <PMID>25877290</PMID>
  </reference>
  <reference>
    <citation>Kaur C, Sema A, Beri RS, Puliyel JM. A simple circuit to deliver bubbling CPAP. Indian Pediatr. 2008 Apr;45(4):312-4.</citation>
    <PMID>18451452</PMID>
  </reference>
  <reference>
    <citation>Anwaar O, Hussain M, Shakeel M, Ahsan Baig MM. Outcome Of Use Of Nasal Continuous Positive Airway Pressure Through Infant Flow Drivers In Neonates With Respiratory Distress In A Tertiary Care Hospital In Pakistan. J Ayub Med Coll Abbottabad. 2018 Oct-Dec;30(4):511-555.</citation>
    <PMID>30632326</PMID>
  </reference>
  <reference>
    <citation>Hedstrom AB, Gove NE, Mayock DE, Batra M. Performance of the Silverman Andersen Respiratory Severity Score in predicting PCO2 and respiratory support in newborns: a prospective cohort study. J Perinatol. 2018 May;38(5):505-511. doi: 10.1038/s41372-018-0049-3. Epub 2018 Feb 9.</citation>
    <PMID>29426853</PMID>
  </reference>
  <reference>
    <citation>Wilson PT, Baiden F, Brooks JC, Morris MC, Giessler K, Punguyire D, Apio G, Agyeman-Ampromfi A, Lopez-Pintado S, Sylverken J, Nyarko-Jectey K, Tagbor H, Moresky RT. Continuous positive airway pressure for children with undifferentiated respiratory distress in Ghana: an open-label, cluster, crossover trial. Lancet Glob Health. 2017 Jun;5(6):e615-e623. doi: 10.1016/S2214-109X(17)30145-6.</citation>
    <PMID>28495265</PMID>
  </reference>
  <reference>
    <citation>Al-Lawama M, Alkhatib H, Wakileh Z, Elqaisi R, AlMassad G, Badran E, Hartman T. Bubble CPAP therapy for neonatal respiratory distress in level III neonatal unit in Amman, Jordan: a prospective observational study. Int J Gen Med. 2018 Dec 24;12:25-30. doi: 10.2147/IJGM.S185264. eCollection 2019.</citation>
    <PMID>30636889</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Edward Medical University</investigator_affiliation>
    <investigator_full_name>Tehreem Fatima</investigator_full_name>
    <investigator_title>Tehreem Fatima, Senior Registrar, Children Hospital &amp; ICH Faisalabad.</investigator_title>
  </responsible_party>
  <keyword>bubble CPAP</keyword>
  <keyword>respiratory distress</keyword>
  <keyword>neonates</keyword>
  <keyword>Silverman Anderson Retraction Score</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04401696
org study id: BubbleCPAP
nct id: NCT04401696
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of study is to determine the effectiveness of bubble Continuous Positive Airway
      Pressure (bCPAP) in neonates presenting with respiratory distress as compared to the control
      group ( using oxygen via nasal cannula). The effectiveness will be calculated in terms of
      reduction in Silverman Anderson Retraction Score.
After approval from the IRB of King Edward Medical University, and taking informed consent
      from parents of the participants, total of 120 neonates fulfilling inclusion and exclusion
      criteria will be enrolled and randomly allocated in two groups; group A and group B. All
      demographic details of participants in both groups be collected. In group A, neonates will be
      given bCPAP for respiratory support while neonates in group B, will be given nasal oxygen as
      control group. Neonates in both groups will be followed for 48 hours. The effectiveness will
      be determined by the reduction in Silverman Anderson Retraction Score (SARS) up to or less
      than 3, at the end of 48 hours. Data will be collected and analysed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness of Bubble CPAP determined by improvement in Silvermann Anderson Retraction Score
time frame: 48 hours since application of intervention
description: Neonates in both groups will be followed-up for 48 hours. SAR Score will be recorded at 0 and 48 hours. It consists of five components: (1) chest retractions (2) retraction of the lower intercostal muscles (3) xiphoid retractions (4) flaring of nares with inhalation (5) grunting on exhalation. Each of the five factors is graded 0, 1 and 2. The sum of these factors yields the total score; minimum score is '0' and maximum score is '10'. The higher the score, the greater is the severity of respiratory distress. So the severity of respiratory distress can be graded according to the SAR Score as Mild (score 0-3), Moderate (score4-6) and Severe (score 6-10). Effectiveness is recorded as 'positive' in case of reduction in SARS score ≤3. A cut-off of score '3' is taken. So if the score of 3 or less than 3 is achieved with bCPAP or with nasal oxygen after 48 hours of intervention, the intervention is considered to be effective
measure: Mean reduction in SAR Score
time frame: 48 hours
description: Mean reduction in Silverman Anderson Retraction Score, over a period of 48 hours, in both groups
measure: Difference in mean reduction
time frame: 48 hours
description: difference between both the groups, will also be calculated.
arm group label: Group A
arm group type: Experimental
description: Use of Bubble CPAP for management of respiratory distress
arm group label: Group B
arm group type: Active Comparator
description: Use of Oxygen via nasal cannula for respiratory distress
intervention type: Device
intervention name: Bubble CPAP
description: The bCPAP will be delivered using an oxygen flow meter as the oxygen source. This inspiratory limb containing oxygen from the flow meter will be connected to humidifier and tubing from humidifier will be connected to short binasal prongs, which would be applied to neonate with the help of adhesive bandage on both cheeks. It will be ensured that binasal prongs make appropriate seal. An orogastric tube will be placed for gastric decompression. A 1000 ml/500ml bottle filled with sterile water be used and marks will be made on it at 1cm distance, with '10' marked at base and '0' mark at the water interface.
The expiratory limb from the nasal prongs was connected to tubing that will be dipped in water up to the desired level to provide positive end expiratory pressure. Pressure is varied by varying the depth of the dipped end of tubing.
arm group label: Group A
intervention type: Other
intervention name: Nasal Oxygen
description: The oxygen will be delivered from a wall oxygen source, delivered between 1 to 6 L/min and the rate varied via a flow regulator.
arm group label: Group B
criteria: 
gender: All
minimum age: 1 Hour
maximum age: 28 Days
healthy volunteers: No
last name: Tehreem Fatima, FCPS
role: Principal Investigator
affiliation: King Edward Medical University
facility: 
country: Pakistan
citation: Chen A, Deshmukh AA, Richards-Kortum R, Molyneux E, Kawaza K, Cantor SB. Cost-effectiveness analysis of a low-cost bubble CPAP device in providing ventilatory support for neonates in Malawi - a preliminary report. BMC Pediatr. 2014 Nov 25;14:288. doi: 10.1186/s12887-014-0288-1.
PMID: 25421903
citation: Mustufa MA, Korejo R, Shahid A, Nasim S. Infection remains a leading cause of neonatal mortality among infants delivered at a tertiary hospital in Karachi, Pakistan. J Infect Dev Ctries. 2014 Sep 13;8(11):1470-5. doi: 10.3855/jidc.3569.
PMID: 25390060
citation: Daga S, Mhatre S, Borhade A, Khan D. Home-made continuous positive airways pressure device may reduce mortality in neonates with respiratory distress in low-resource setting. J Trop Pediatr. 2014 Oct;60(5):343-7. doi: 10.1093/tropej/fmu023. Epub 2014 Apr 23.
PMID: 24760748
citation: Kawaza K, Machen HE, Brown J, Mwanza Z, Iniguez S, Gest A, Smith EO, Oden M, Richards-Kortum RR, Molyneux E. Efficacy of a low-cost bubble CPAP system in treatment of respiratory distress in a neonatal ward in Malawi. PLoS One. 2014 Jan 29;9(1):e86327. doi: 10.1371/journal.pone.0086327. eCollection 2014.
PMID: 24489715
citation: Brown J, Machen H, Kawaza K, Mwanza Z, Iniguez S, Lang H, Gest A, Kennedy N, Miros R, Richards-Kortum R, Molyneux E, Oden M. A high-value, low-cost bubble continuous positive airway pressure system for low-resource settings: technical assessment and initial case reports. PLoS One. 2013;8(1):e53622. doi: 10.1371/journal.pone.0053622. Epub 2013 Jan 23.
PMID: 23372661
citation: Stoll BJ, Hansen NI, Bell EF, Walsh MC, Carlo WA, Shankaran S, Laptook AR, Sanchez PJ, Van Meurs KP, Wyckoff M, Das A, Hale EC, Ball MB, Newman NS, Schibler K, Poindexter BB, Kennedy KA, Cotten CM, Watterberg KL, D'Angio CT, DeMauro SB, Truog WE, Devaskar U, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012. JAMA. 2015 Sep 8;314(10):1039-51. doi: 10.1001/jama.2015.10244.
PMID: 26348753
citation: Hundalani SG, Richards-Kortum R, Oden M, Kawaza K, Gest A, Molyneux E. Development and validation of a simple algorithm for initiation of CPAP in neonates with respiratory distress in Malawi. Arch Dis Child Fetal Neonatal Ed. 2015 Jul;100(4):F332-6. doi: 10.1136/archdischild-2014-308082. Epub 2015 Apr 15.
PMID: 25877290
citation: Kaur C, Sema A, Beri RS, Puliyel JM. A simple circuit to deliver bubbling CPAP. Indian Pediatr. 2008 Apr;45(4):312-4.
PMID: 18451452
citation: Anwaar O, Hussain M, Shakeel M, Ahsan Baig MM. Outcome Of Use Of Nasal Continuous Positive Airway Pressure Through Infant Flow Drivers In Neonates With Respiratory Distress In A Tertiary Care Hospital In Pakistan. J Ayub Med Coll Abbottabad. 2018 Oct-Dec;30(4):511-555.
PMID: 30632326
citation: Hedstrom AB, Gove NE, Mayock DE, Batra M. Performance of the Silverman Andersen Respiratory Severity Score in predicting PCO2 and respiratory support in newborns: a prospective cohort study. J Perinatol. 2018 May;38(5):505-511. doi: 10.1038/s41372-018-0049-3. Epub 2018 Feb 9.
PMID: 29426853
citation: Wilson PT, Baiden F, Brooks JC, Morris MC, Giessler K, Punguyire D, Apio G, Agyeman-Ampromfi A, Lopez-Pintado S, Sylverken J, Nyarko-Jectey K, Tagbor H, Moresky RT. Continuous positive airway pressure for children with undifferentiated respiratory distress in Ghana: an open-label, cluster, crossover trial. Lancet Glob Health. 2017 Jun;5(6):e615-e623. doi: 10.1016/S2214-109X(17)30145-6.
PMID: 28495265
citation: Al-Lawama M, Alkhatib H, Wakileh Z, Elqaisi R, AlMassad G, Badran E, Hartman T. Bubble CPAP therapy for neonatal respiratory distress in level III neonatal unit in Amman, Jordan: a prospective observational study. Int J Gen Med. 2018 Dec 24;12:25-30. doi: 10.2147/IJGM.S185264. eCollection 2019.
PMID: 30636889
responsible party type: Principal Investigator
investigator affiliation: King Edward Medical University
investigator full name: Tehreem Fatima
investigator title: Tehreem Fatima, Senior Registrar, Children Hospital & ICH Faisalabad.
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Distress Syndrome
sharing ipd: No