<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/NCT03036787</url>
  </required_header>
  <id_info>
    <org_study_id>11223</org_study_id>
    <nct_id>NCT03036787</nct_id>
  </id_info>
  <brief_title>Is There Any Differences in Motor and Cognitive Development Between Preterm and Early Preterm Infants?</brief_title>
  <official_title>Is There Any Differences in Motor And Cognitive Development Between Preterm (&lt;37 Weeks) and Early Preterm (&lt;32 Weeks) Infants? Two Years Follow Up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gazi University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Infant born preterm have an increased risk of adverse long-term developmental outcomes.The&#xD;
      risk associated with preterm birth increase as gestational age decreases, and vulnerability&#xD;
      remains in extremely- very preterm (&lt;32 weeks) and moderate- late preterm (&gt;32 weeks). There&#xD;
      are many studies in the literature showed that the prevalence of developmental delay&#xD;
      increases with premature birth. However, there is no study in the literature investigates&#xD;
      long term follow up motor and cognitive development in subgroups of preterm infants . Hence&#xD;
      the aim of this study is to evaluate the differences in motor and cognitive development in&#xD;
      moderate-late (&gt;32 weeks) and extremely-very preterm infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A convenience of infants with premature birth recruiting from Gazi University, Faculty of&#xD;
      Health Science, Department of Physiotherapy and Rehabilitation. Babies divide into two groups&#xD;
      according to the gestational ages. Babies with gestational ages between 32-36 weeks and 6&#xD;
      days (including the given days) are categorized as moderate-late preterm, while those born&#xD;
      before 32 weeks are grouped as extremely and very preterm. Each group contains 20 babies.&#xD;
      First, sociodemographic information and histories of babies are obtaining. Ages and contact&#xD;
      information of the parents are recording. Prenatal and natal risk factors of the mothers are&#xD;
      querying. Gestational ages and height, weight, and head circumferences of babies at birth are&#xD;
      recording. Number of pregnancies, live births and abortions, type of delivery, multiple&#xD;
      pregnancies for mothers as well as consanguinity between parents are asking.The Alberta&#xD;
      Infant Motor Scale is using to evaluate spontaneous motor movements of the baby. It evaluates&#xD;
      the baby at prone, supine, sitting, and standing positions. Bayley Scales of Infant and&#xD;
      Toddler Development scales screen for cognitive, language, and motor development in babies.&#xD;
      All infants will be testing in 3-6-9-12-15-18-24 months of ages.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Actual">February 9, 2014</start_date>
  <completion_date type="Actual">September 27, 2018</completion_date>
  <primary_completion_date type="Actual">February 2, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Motor development assessed with the Alberta Infant Motor Scale</measure>
    <time_frame>Each 3 months from beginning to two years</time_frame>
    <description>The Alberta Infant Motor Scale is going to use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive development assessed with the Bayley Scales of Infant and Toddler Development</measure>
    <time_frame>Each 3 months from beginning to two years</time_frame>
    <description>Bayley Scales of Infant and Toddler Development</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Premature Baby</condition>
  <arm_group>
    <arm_group_label>moderate-early preterm infants</arm_group_label>
    <description>infant who births in 32 weeks to 37 weeks with family based intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>extremely-very preterm infants</arm_group_label>
    <description>infant who births in 27 weeks to 32 weeks with family based intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>family based intervention</intervention_name>
    <description>behavioural advises to family for normal motor development</description>
    <arm_group_label>extremely-very preterm infants</arm_group_label>
    <arm_group_label>moderate-early preterm infants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        preterm infants born with &lt;37 weeks.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adjusted age of 24 months or less, born with a gestational age of 36 weeks and 6 days&#xD;
             or earlier, not having any systemic disease, and accepting to join the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age greater than 24 months and born with a gestational age of 37 weeks or more&#xD;
&#xD;
          -  having major risk factor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bulent Elbasan, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>Gazi University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation</name>
      <address>
        <city>Ankara</city>
        <zip>06500</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>September 27, 2018</last_update_submitted>
  <last_update_submitted_qc>September 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>Muserrefe Nur Keles</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>Premature Baby</keyword>
  <keyword>motor development</keyword>
  <keyword>cognitive development</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>
    <ipd_description>We have no decided yet</ipd_description>
  </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/NCT03036787
org study id: 11223
nct id: NCT03036787
lead sponsor: 
has dmc: Yes
Infant born preterm have an increased risk of adverse long-term developmental outcomes.The
      risk associated with preterm birth increase as gestational age decreases, and vulnerability
      remains in extremely- very preterm (<32 weeks) and moderate- late preterm (>32 weeks). There
      are many studies in the literature showed that the prevalence of developmental delay
      increases with premature birth. However, there is no study in the literature investigates
      long term follow up motor and cognitive development in subgroups of preterm infants . Hence
      the aim of this study is to evaluate the differences in motor and cognitive development in
      moderate-late (>32 weeks) and extremely-very preterm infants.
A convenience of infants with premature birth recruiting from Gazi University, Faculty of
      Health Science, Department of Physiotherapy and Rehabilitation. Babies divide into two groups
      according to the gestational ages. Babies with gestational ages between 32-36 weeks and 6
      days (including the given days) are categorized as moderate-late preterm, while those born
      before 32 weeks are grouped as extremely and very preterm. Each group contains 20 babies.
      First, sociodemographic information and histories of babies are obtaining. Ages and contact
      information of the parents are recording. Prenatal and natal risk factors of the mothers are
      querying. Gestational ages and height, weight, and head circumferences of babies at birth are
      recording. Number of pregnancies, live births and abortions, type of delivery, multiple
      pregnancies for mothers as well as consanguinity between parents are asking.The Alberta
      Infant Motor Scale is using to evaluate spontaneous motor movements of the baby. It evaluates
      the baby at prone, supine, sitting, and standing positions. Bayley Scales of Infant and
      Toddler Development scales screen for cognitive, language, and motor development in babies.
      All infants will be testing in 3-6-9-12-15-18-24 months of ages.
observational model: Family-Based
time perspective: Prospective
measure: Motor development assessed with the Alberta Infant Motor Scale
time frame: Each 3 months from beginning to two years
description: The Alberta Infant Motor Scale is going to use
measure: Cognitive development assessed with the Bayley Scales of Infant and Toddler Development
time frame: Each 3 months from beginning to two years
description: Bayley Scales of Infant and Toddler Development
arm group label: moderate-early preterm infants
description: infant who births in 32 weeks to 37 weeks with family based intervention
arm group label: extremely-very preterm infants
description: infant who births in 27 weeks to 32 weeks with family based intervention
intervention type: Behavioral
intervention name: family based intervention
description: behavioural advises to family for normal motor development
arm group label: extremely-very preterm infants
arm group label: moderate-early preterm infants
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 24 Months
healthy volunteers: No
last name: Bulent Elbasan, Phd
role: Study Chair
affiliation: Gazi University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Gazi University
investigator full name: Muserrefe Nur Keles
investigator title: Research Assistant
mesh term: Premature Birth
sharing ipd: Undecided
ipd description: We have no decided yet