<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/NCT03027206</url>
  </required_header>
  <id_info>
    <org_study_id>1.690.842</org_study_id>
    <nct_id>NCT03027206</nct_id>
  </id_info>
  <brief_title>Respiratory Physiotherapy Change Premature Pain With Pneumonia</brief_title>
  <acronym>RPCPPWP</acronym>
  <official_title>Effects of Vibration Techniques and Expiratory Flow Acceleration in Premature Pain Parameters With Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amazon University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação Santa Casa de Misericórdia do Pará (FSCMPA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Amazon University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective to evaluate the effects of vibration techniques and acceleration of expiratory flow&#xD;
      on pain parameters in preterm infants diagnosed with pneumonia hospitalized in the Intensive&#xD;
      Care Unit and Neonatal Intermediate Care Unit. The Method is a descriptive and interventional&#xD;
      study, in which 28 PTNB were randomly divided into two groups: Group 1 submitted to the&#xD;
      vibration technique and Group 2 - to the acceleration of the expiratory flow, both techniques&#xD;
      were applied in an interval of up to ten minutes, for Three consecutive days. The pain&#xD;
      indicators were evaluated according to the PIPP scale in three moments. For statistical&#xD;
      analysis, the Friedman tests and Variance Analysis were applied, the level of significance&#xD;
      adopted was 5%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A descriptive, longitudinal, quantitative approach was carried out in which 28 preterm&#xD;
      infants with diagnosis of pneumonia hospitalized in the NICU and NICU of the Santa Casa de&#xD;
      Misericórdia Foundation of Pará (FSCMPA) participated in the study period from July to&#xD;
      October 2016. The research obeyed ethical principles Of Resolution 466/12 of the National&#xD;
      Health Council (CNS) and was initiated after approval by the Research Ethics Committee of the&#xD;
      FSCMPA, opinion 1,690,842. The selection criteria were obtained through the collection of&#xD;
      data from the records of newborns and annotated in standardized charts. Once included in the&#xD;
      study, the patients were randomly divided into two groups of 14 PTNB, the premature group 1&#xD;
      were submitted to the vibration technique (rhythmic and rapid movements of isometric&#xD;
      contraction of the forearm, applied manually over the anterior chest region) and the Of Group&#xD;
      2 to the acceleration of the expiratory flow (soft compression of the thorax applied with one&#xD;
      hand in the lower ribs and the other using the ulnar border on the supramammary line). Both&#xD;
      techniques were performed with the premature dorsal position, at the time of the expiratory&#xD;
      phase, with a maximum duration of 10 minutes, once a day, for three consecutive days, in the&#xD;
      afternoon period and by the same physiotherapist. After this procedure, aspiration of the&#xD;
      upper airways of premature infants was performed. The pain indicators of the preterm infants&#xD;
      (PIPP) of the two groups were evaluated in three moments, before the application of the&#xD;
      technique (T1), immediately after the application of the technique (T2) and 15 minutes After&#xD;
      its completion (T3), by a researcher previously trained and blind regarding the procedure&#xD;
      performed. PIPP is a multidimensional instrument that evaluates pain indicators in the&#xD;
      newborn using the following parameters: gestational age and alertness (contextual factors),&#xD;
      heart rate and peripheral oxygen saturation (physiological indicators) that were measured by&#xD;
      means of a pulse oximeter Of the brand (Dixtal®) and three aspects of facial mimetics&#xD;
      (behavioral factors). Their scores may range from 0 to 21, scores less than or equal to 6&#xD;
      indicate absence of pain, scores above 6 represent mild pain and scores higher than 12&#xD;
      indicate the presence of moderate to severe pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Early Phase 1</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the parameters of the pain profile scale in preterm infants at different times</measure>
    <time_frame>The total collection period was six months, and each procedure was performed on the volunteers for three consecutive days.</time_frame>
    <description>The pain indicators of the preterm infants (PIPP) of the two groups were evaluated in three moments, before the application of the technique (T1), immediately after the application of the technique (T2) and 15 minutes After its termination (T3), by a researcher previously trained and blind as to the procedure performed</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Premature</condition>
  <condition>Pneumonia</condition>
  <condition>Pain</condition>
  <condition>Physiotherapy</condition>
  <arm_group>
    <arm_group_label>Vibration technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rhythmic and rapid movements of isometric contraction of the forearm, applied manually over the anterior region of the thorax</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acceleration of expiratory flow</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Soft compression of the thorax applied with one hand on the lower ribs and the other using the ulnar border on the supramammary line</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vibration technique</intervention_name>
    <description>Comparison of different technique</description>
    <arm_group_label>Vibration technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acceleration of expiratory flow</intervention_name>
    <description>Comparison of different technique</description>
    <arm_group_label>Acceleration of expiratory flow</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Included in this study were RNPT of both genders, of low weight (1500 to 2500g) or&#xD;
             normal weight (over 2500g).&#xD;
&#xD;
          -  With clinical diagnosis of pneumonia.&#xD;
&#xD;
          -  Who were on spontaneous ventilation (ambient air or with the aid of oxygen therapy).&#xD;
&#xD;
          -  Agreed to participate in the research, through the signing of the Informed Consent&#xD;
             Form for minors.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Newborns with a gestational age greater than 37 weeks.&#xD;
&#xD;
          -  With diseases or procedures that cause pain in the newborn such as necrotizing&#xD;
             enterocolitis, thoracotraumatis, thoracic or abdominal drainage, and umbilical&#xD;
             catheter.&#xD;
&#xD;
          -  Who were less than 72 hours Life with birth weight less than 1500g (very low weight&#xD;
             and extreme low weight).&#xD;
&#xD;
          -  As well as those who underwent invasive or non-invasive mechanical ventilation.&#xD;
&#xD;
          -  Sedated.&#xD;
&#xD;
          -  With vasoactive drugs or medications that interfered in the physiological parameters&#xD;
             of pain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Patel RM, Kandefer S, Walsh MC, Bell EF, Carlo WA, Laptook AR, Sanchez PJ, Shankaran S, Van Meurs KP, Ball MB, Hale EC, Newman NS, Das A, Higgins RD, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Causes and timing of death in extremely premature infants from 2000 through 2011. N Engl J Med. 2015 Jan 22;372(4):331-40. doi: 10.1056/NEJMoa1403489.</citation>
    <PMID>25607427</PMID>
  </results_reference>
  <results_reference>
    <citation>Walker CLF, Rudan I, Liu L, Nair H, Theodoratou E, Bhutta ZA, O'Brien KL, Campbell H, Black RE. Global burden of childhood pneumonia and diarrhoea. Lancet. 2013 Apr 20;381(9875):1405-1416. doi: 10.1016/S0140-6736(13)60222-6. Epub 2013 Apr 12.</citation>
    <PMID>23582727</PMID>
  </results_reference>
  <results_reference>
    <citation>Brandao AM, Domingues AP, Fonseca EM, Miranda TM, Belo A, Moura JP. [Premature labour with or without preterm premature rupture of membranes: maternal, obstetric and neonatal features]. Rev Bras Ginecol Obstet. 2015 Sep;37(9):428-33. doi: 10.1590/SO100-720320150005283. Portuguese.</citation>
    <PMID>26352946</PMID>
  </results_reference>
  <results_reference>
    <citation>Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2016 Jul 16;7(7):CD001069. doi: 10.1002/14651858.CD001069.pub5.</citation>
    <PMID>27420164</PMID>
  </results_reference>
  <results_reference>
    <citation>Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846.</citation>
    <PMID>15060237</PMID>
  </results_reference>
  <results_reference>
    <citation>Silva YP, Gomez RS, Maximo TA, Silva AC. [Pain evaluation in neonatology.]. Rev Bras Anestesiol. 2007 Oct;57(5):565-74. Portuguese.</citation>
    <PMID>19462133</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Amazon University</investigator_affiliation>
    <investigator_full_name>Paulo Eduardo Santos Avila</investigator_full_name>
    <investigator_title>Assistant teacher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Premature Birth</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/NCT03027206
org study id: 1.690.842
nct id: NCT03027206
lead sponsor: 
collaborator: 
has dmc: Yes
Objective to evaluate the effects of vibration techniques and acceleration of expiratory flow
      on pain parameters in preterm infants diagnosed with pneumonia hospitalized in the Intensive
      Care Unit and Neonatal Intermediate Care Unit. The Method is a descriptive and interventional
      study, in which 28 PTNB were randomly divided into two groups: Group 1 submitted to the
      vibration technique and Group 2 - to the acceleration of the expiratory flow, both techniques
      were applied in an interval of up to ten minutes, for Three consecutive days. The pain
      indicators were evaluated according to the PIPP scale in three moments. For statistical
      analysis, the Friedman tests and Variance Analysis were applied, the level of significance
      adopted was 5%.
A descriptive, longitudinal, quantitative approach was carried out in which 28 preterm
      infants with diagnosis of pneumonia hospitalized in the NICU and NICU of the Santa Casa de
      Misericórdia Foundation of Pará (FSCMPA) participated in the study period from July to
      October 2016. The research obeyed ethical principles Of Resolution 466/12 of the National
      Health Council (CNS) and was initiated after approval by the Research Ethics Committee of the
      FSCMPA, opinion 1,690,842. The selection criteria were obtained through the collection of
      data from the records of newborns and annotated in standardized charts. Once included in the
      study, the patients were randomly divided into two groups of 14 PTNB, the premature group 1
      were submitted to the vibration technique (rhythmic and rapid movements of isometric
      contraction of the forearm, applied manually over the anterior chest region) and the Of Group
      2 to the acceleration of the expiratory flow (soft compression of the thorax applied with one
      hand in the lower ribs and the other using the ulnar border on the supramammary line). Both
      techniques were performed with the premature dorsal position, at the time of the expiratory
      phase, with a maximum duration of 10 minutes, once a day, for three consecutive days, in the
      afternoon period and by the same physiotherapist. After this procedure, aspiration of the
      upper airways of premature infants was performed. The pain indicators of the preterm infants
      (PIPP) of the two groups were evaluated in three moments, before the application of the
      technique (T1), immediately after the application of the technique (T2) and 15 minutes After
      its completion (T3), by a researcher previously trained and blind regarding the procedure
      performed. PIPP is a multidimensional instrument that evaluates pain indicators in the
      newborn using the following parameters: gestational age and alertness (contextual factors),
      heart rate and peripheral oxygen saturation (physiological indicators) that were measured by
      means of a pulse oximeter Of the brand (Dixtal®) and three aspects of facial mimetics
      (behavioral factors). Their scores may range from 0 to 21, scores less than or equal to 6
      indicate absence of pain, scores above 6 represent mild pain and scores higher than 12
      indicate the presence of moderate to severe pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Evaluation of the parameters of the pain profile scale in preterm infants at different times
time frame: The total collection period was six months, and each procedure was performed on the volunteers for three consecutive days.
description: The pain indicators of the preterm infants (PIPP) of the two groups were evaluated in three moments, before the application of the technique (T1), immediately after the application of the technique (T2) and 15 minutes After its termination (T3), by a researcher previously trained and blind as to the procedure performed
arm group label: Vibration technique
arm group type: Experimental
description: Rhythmic and rapid movements of isometric contraction of the forearm, applied manually over the anterior region of the thorax
arm group label: Acceleration of expiratory flow
arm group type: Experimental
description: Soft compression of the thorax applied with one hand on the lower ribs and the other using the ulnar border on the supramammary line
intervention type: Other
intervention name: Vibration technique
description: Comparison of different technique
arm group label: Vibration technique
intervention type: Other
intervention name: Acceleration of expiratory flow
description: Comparison of different technique
arm group label: Acceleration of expiratory flow
criteria: 
gender: All
minimum age: 1 Day
maximum age: 28 Days
healthy volunteers: No
citation: Patel RM, Kandefer S, Walsh MC, Bell EF, Carlo WA, Laptook AR, Sanchez PJ, Shankaran S, Van Meurs KP, Ball MB, Hale EC, Newman NS, Das A, Higgins RD, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Causes and timing of death in extremely premature infants from 2000 through 2011. N Engl J Med. 2015 Jan 22;372(4):331-40. doi: 10.1056/NEJMoa1403489.
PMID: 25607427
citation: Walker CLF, Rudan I, Liu L, Nair H, Theodoratou E, Bhutta ZA, O'Brien KL, Campbell H, Black RE. Global burden of childhood pneumonia and diarrhoea. Lancet. 2013 Apr 20;381(9875):1405-1416. doi: 10.1016/S0140-6736(13)60222-6. Epub 2013 Apr 12.
PMID: 23582727
citation: Brandao AM, Domingues AP, Fonseca EM, Miranda TM, Belo A, Moura JP. [Premature labour with or without preterm premature rupture of membranes: maternal, obstetric and neonatal features]. Rev Bras Ginecol Obstet. 2015 Sep;37(9):428-33. doi: 10.1590/SO100-720320150005283. Portuguese.
PMID: 26352946
citation: Stevens B, Yamada J, Ohlsson A, Haliburton S, Shorkey A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2016 Jul 16;7(7):CD001069. doi: 10.1002/14651858.CD001069.pub5.
PMID: 27420164
citation: Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846.
PMID: 15060237
citation: Silva YP, Gomez RS, Maximo TA, Silva AC. [Pain evaluation in neonatology.]. Rev Bras Anestesiol. 2007 Oct;57(5):565-74. Portuguese.
PMID: 19462133
responsible party type: Principal Investigator
investigator affiliation: Amazon University
investigator full name: Paulo Eduardo Santos Avila
investigator title: Assistant teacher
mesh term: Pneumonia
mesh term: Premature Birth
sharing ipd: No