<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/NCT01660178</url>
  </required_header>
  <id_info>
    <org_study_id>FDAAA</org_study_id>
    <nct_id>NCT01660178</nct_id>
  </id_info>
  <brief_title>Profile of Newborn Undergoing Early Stimulation in a Neonatal Intensive Care Unit</brief_title>
  <official_title>Profile of Newborn Undergoing Early Stimulation in a Neonatal Intensive Care Unit.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio de Janeiro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio de Janeiro</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To describe the profile of newborns undergoing early stimulation in a neonatal intensive care&#xD;
      unit, characterizing the study population, according to its variables and neonatal risk&#xD;
      factors, indications for treatment of early stimulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To describe the profile of newborns undergoing early stimulation in a neonatal&#xD;
      intensive care unit, characterizing the study population, according to its variables and&#xD;
      neonatal risk factors, indications for treatment of early stimulation.&#xD;
&#xD;
      Methods: It was conducted a descriptive, cross-sectional and analytical study carried out in&#xD;
      the General Hospital Dr. Cesar calls, from July to December 2010. The sample consisted of 116&#xD;
      medical records of newborns indicated for the treatment of early stimulation, representing&#xD;
      (9.2%). The study excluded seven infants who had some type of congenital malformation. It was&#xD;
      used the following variables: weight, sex, gestational age, Apgar score, diagnosis of&#xD;
      Respiratory Distress Syndrome and Intracranial Hemorrhage and the use of mechanical&#xD;
      ventilation and CPAP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <condition>Motor Skills Disorders</condition>
  <eligibility>
    <study_pop>
      <textblock>
        newborns underwent early stimulation in a neonatal ICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All cases of newborns who were admitted to the NICU and were referred for treatment of&#xD;
        early stimulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        all records relating to incomplete study variables and newborns who had a congenital&#xD;
        malformation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>August 7, 2012</last_update_submitted>
  <last_update_submitted_qc>August 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio de Janeiro</investigator_affiliation>
    <investigator_full_name>karla camila lima de souza</investigator_full_name>
    <investigator_title>camila souza</investigator_title>
  </responsible_party>
  <keyword>newborns</keyword>
  <keyword>intensive care unit</keyword>
  <keyword>early stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Skills Disorders</mesh_term>
  </condition_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/NCT01660178
org study id: FDAAA
nct id: NCT01660178
lead sponsor: 
has dmc: No
To describe the profile of newborns undergoing early stimulation in a neonatal intensive care
      unit, characterizing the study population, according to its variables and neonatal risk
      factors, indications for treatment of early stimulation.
Objective: To describe the profile of newborns undergoing early stimulation in a neonatal
      intensive care unit, characterizing the study population, according to its variables and
      neonatal risk factors, indications for treatment of early stimulation.

      Methods: It was conducted a descriptive, cross-sectional and analytical study carried out in
      the General Hospital Dr. Cesar calls, from July to December 2010. The sample consisted of 116
      medical records of newborns indicated for the treatment of early stimulation, representing
      (9.2%). The study excluded seven infants who had some type of congenital malformation. It was
      used the following variables: weight, sex, gestational age, Apgar score, diagnosis of
      Respiratory Distress Syndrome and Intracranial Hemorrhage and the use of mechanical
      ventilation and CPAP.
time perspective: Retrospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio de Janeiro
investigator full name: karla camila lima de souza
investigator title: camila souza
mesh term: Motor Skills Disorders