<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/NCT03025815</url>
  </required_header>
  <id_info>
    <org_study_id>41366915.5.0000.5327</org_study_id>
    <nct_id>NCT03025815</nct_id>
  </id_info>
  <brief_title>Effects of the Oral Stimulation Program in Extreme Preterm Infants</brief_title>
  <official_title>Effects of the Oral Stimulation Program in Extreme Preterm Infants: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether oral stimulation program are effective to&#xD;
      improve oral feeding efficiency. The sample size estimated in 74 preterm, randomized&#xD;
      classification of the subjects into to experimental and a control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent studies have suggested that an oral stimulation program applied to preterm infants&#xD;
      facilitates their oral feeding progress, improve breastfeeding rates in preterm infants and&#xD;
      decreases the length of hospital stay. The objective of this study will evaluate the effect&#xD;
      an oral stimulation program on the performance feeding, the length of the transition oral&#xD;
      feeding, length of hospital stay and breastfeeding rates upon discharge.&#xD;
&#xD;
      Primarily, will be evaluated the effect an oral stimulation program on the performance&#xD;
      feeding. All infants will be assessed by a speech pathologist blinded as to the group&#xD;
      randomization.&#xD;
&#xD;
      Secondarily, will be observed the length of the transition oral feeding of the preterm&#xD;
      infants, conducted by medical team and will be observed length of hospital stay. Both groups&#xD;
      will be monitored from when they were assigned to participate in the study until hospital&#xD;
      discharge.&#xD;
&#xD;
      All statistical will be conducted using Statistical Package for Social Sciences® version&#xD;
      18.0. The data will be analyzed for treatment group differences with chi-square or Fisher's&#xD;
      exact tests for the categorical variables and with non-parametric tests for the continuous&#xD;
      variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Supportive Care</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oral feeding performance</measure>
    <time_frame>20 minutes</time_frame>
    <description>The volume transfer is as considered as the percentage of the volume consumed (%).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oral feeding transition time</measure>
    <time_frame>60 days</time_frame>
    <description>number of days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days hospital stay</measure>
    <time_frame>6 months</time_frame>
    <description>number of days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Infant, Premature</condition>
  <condition>Feeding Behavior</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>sham stimulation program consists of the same researcher placing her hands for 15 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention group</intervention_name>
    <description>Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely.</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>Oral stimulation program</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>sham stimulation program consists of the same researcher placing her hands for 15 minutes.</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Sham stimulation program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infants with between 26 and 32 weeks gestational age as determined by date of last&#xD;
             menstruation and first trimester ultrasound or by clinical examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infants with medical complications, such as grades III or IV intraventricular&#xD;
             hemorrhage or periventricular leukomalacia&#xD;
&#xD;
          -  congenital diseases such as chromosomal or genetic abnormalities&#xD;
&#xD;
          -  bronchopulmonary dysplasia&#xD;
&#xD;
          -  necrotizing enterocolitis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>26 Weeks</minimum_age>
    <maximum_age>32 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rita C Silveira, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Neonatal Section</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infant, Premature</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03025815
org study id: 41366915.5.0000.5327
nct id: NCT03025815
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether oral stimulation program are effective to
      improve oral feeding efficiency. The sample size estimated in 74 preterm, randomized
      classification of the subjects into to experimental and a control group.
Recent studies have suggested that an oral stimulation program applied to preterm infants
      facilitates their oral feeding progress, improve breastfeeding rates in preterm infants and
      decreases the length of hospital stay. The objective of this study will evaluate the effect
      an oral stimulation program on the performance feeding, the length of the transition oral
      feeding, length of hospital stay and breastfeeding rates upon discharge.

      Primarily, will be evaluated the effect an oral stimulation program on the performance
      feeding. All infants will be assessed by a speech pathologist blinded as to the group
      randomization.

      Secondarily, will be observed the length of the transition oral feeding of the preterm
      infants, conducted by medical team and will be observed length of hospital stay. Both groups
      will be monitored from when they were assigned to participate in the study until hospital
      discharge.

      All statistical will be conducted using Statistical Package for Social Sciences® version
      18.0. The data will be analyzed for treatment group differences with chi-square or Fisher's
      exact tests for the categorical variables and with non-parametric tests for the continuous
      variables.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Care Provider, Investigator)
measure: Oral feeding performance
time frame: 20 minutes
description: The volume transfer is as considered as the percentage of the volume consumed (%).
measure: Oral feeding transition time
time frame: 60 days
description: number of days
measure: Days hospital stay
time frame: 6 months
description: number of days
arm group label: Intervention group
arm group type: Experimental
description: Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely.
arm group label: Control group
arm group type: Sham Comparator
description: sham stimulation program consists of the same researcher placing her hands for 15 minutes.
intervention type: Other
intervention name: Intervention group
description: Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely.
arm group label: Intervention group
other name: Oral stimulation program
intervention type: Other
intervention name: Control group
description: sham stimulation program consists of the same researcher placing her hands for 15 minutes.
arm group label: Control group
other name: Sham stimulation program
criteria: 
gender: All
minimum age: 26 Weeks
maximum age: 32 Weeks
healthy volunteers: No
last name: Rita C Silveira, Professor
role: Principal Investigator
affiliation: Neonatal Section
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Premature Birth
sharing ipd: Undecided