<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/NCT03232190</url>
  </required_header>
  <id_info>
    <org_study_id>B331201422729</org_study_id>
    <nct_id>NCT03232190</nct_id>
  </id_info>
  <brief_title>The Use of an Age-linked App for Parents During and After a NICU Stay</brief_title>
  <official_title>The Use of an Age-linked Web Application for Parents During and After a NICU Stay in Improving Child Development and Parent Empowerment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ziekenhuis Oost-Limburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>TRACE: Centre For Translational Psychological Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ziekenhuis Oost-Limburg</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of the neonatal intensive care unit (NICU) is to optimize the development of&#xD;
      the newborn. Preterm children are at greater risk for developmental disorders. On the one&#xD;
      hand, this is due to cerebral complications inherent to the prematurity, on the other hand it&#xD;
      is related to the very early and therefore vulnerable stage of brain development at the time&#xD;
      of the premature birth. The development of the child is also the result of a constant&#xD;
      interaction between the infant and its environment, primarily the primary caregiver (i.e. the&#xD;
      parents). A premature birth can cause great stress to parents, and there are several&#xD;
      obstacles that can make it difficult to handle their child. Therefore, we have developed a&#xD;
      web application that supports parents until their child reaches the age of two. By keeping&#xD;
      them informed, we hope to make them more confident in their role as parents, and thus&#xD;
      facilitate the parent-child interaction. In order to determine whether this form of support&#xD;
      has an additional effect on the development of the premature child, we compare two groups of&#xD;
      premature infants and a group of non-premature infants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Bayley-III-NL</measure>
    <time_frame>5 months, 1 year, 2 year</time_frame>
    <description>Bayley Scales of Infant and Toddler Development Mental, social and motor development of the child</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in DT-P</measure>
    <time_frame>2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year</time_frame>
    <description>Distress Thermometer for Parents</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in EMPO</measure>
    <time_frame>2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year</time_frame>
    <description>Dutch Empowerment Questionnaire Parental empowerment in raising children (intrapersonal, interactional, and behavioral)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WPPSI-III-NL</measure>
    <time_frame>5 year</time_frame>
    <description>Wechsler Preschool and Primary Scale of Intelligence Cognitive Development of the Child</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in PNAR</measure>
    <time_frame>2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year</time_frame>
    <description>Parent Newborn Attachment Relationship Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Premature Birth</condition>
  <arm_group>
    <arm_group_label>INTNIC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NICU Intervention Group Web Application Infants &lt; 32 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CNIC</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>NICU Control Group No Web Application Infants &lt; 32 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CMAT</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Maternity Unit Control Group No Web Application Infants &gt; 37 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Web Application</intervention_name>
    <description>Parents receive a web application that offers information and support until the age of 2.</description>
    <arm_group_label>INTNIC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premature birth (&lt; 32 weeks)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The lack of internet access or a personal email account&#xD;
&#xD;
          -  Little or no knowledge of Dutch in both parents&#xD;
&#xD;
          -  Children with a congenital disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>32 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie-Rose Van Hoestenberghe, MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ziekenhuis Oost-Limburg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie-Rose Van Hoestenberghe, MD.</last_name>
    <phone>+32 89 32 76 33</phone>
    <email>marie-rose.vanhoestenberghe@zol.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg, Schiepse Bos 6</name>
      <address>
        <city>Genk</city>
        <state>Limburg</state>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>February 16, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 30, 2019</last_update_submitted>
  <last_update_submitted_qc>July 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ziekenhuis Oost-Limburg</investigator_affiliation>
    <investigator_full_name>Marie-Rose Van Hoestenberghe, MD</investigator_full_name>
    <investigator_title>Neonatologist</investigator_title>
  </responsible_party>
  <keyword>prematurity</keyword>
  <keyword>psychomotor development</keyword>
  <keyword>parent empowerment</keyword>
  <keyword>e-health</keyword>
  <keyword>parental support</keyword>
  <keyword>post discharge follow-up</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>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/NCT03232190
org study id: B331201422729
nct id: NCT03232190
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The main purpose of the neonatal intensive care unit (NICU) is to optimize the development of
      the newborn. Preterm children are at greater risk for developmental disorders. On the one
      hand, this is due to cerebral complications inherent to the prematurity, on the other hand it
      is related to the very early and therefore vulnerable stage of brain development at the time
      of the premature birth. The development of the child is also the result of a constant
      interaction between the infant and its environment, primarily the primary caregiver (i.e. the
      parents). A premature birth can cause great stress to parents, and there are several
      obstacles that can make it difficult to handle their child. Therefore, we have developed a
      web application that supports parents until their child reaches the age of two. By keeping
      them informed, we hope to make them more confident in their role as parents, and thus
      facilitate the parent-child interaction. In order to determine whether this form of support
      has an additional effect on the development of the premature child, we compare two groups of
      premature infants and a group of non-premature infants.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Bayley-III-NL
time frame: 5 months, 1 year, 2 year
description: Bayley Scales of Infant and Toddler Development Mental, social and motor development of the child
measure: Change in DT-P
time frame: 2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year
description: Distress Thermometer for Parents
measure: Change in EMPO
time frame: 2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year
description: Dutch Empowerment Questionnaire Parental empowerment in raising children (intrapersonal, interactional, and behavioral)
measure: WPPSI-III-NL
time frame: 5 year
description: Wechsler Preschool and Primary Scale of Intelligence Cognitive Development of the Child
measure: Change in PNAR
time frame: 2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year
description: Parent Newborn Attachment Relationship Questionnaire
arm group label: INTNIC
arm group type: Experimental
description: NICU Intervention Group Web Application Infants < 32 weeks
arm group label: CNIC
arm group type: No Intervention
description: NICU Control Group No Web Application Infants < 32 weeks
arm group label: CMAT
arm group type: No Intervention
description: Maternity Unit Control Group No Web Application Infants > 37 weeks
intervention type: Other
intervention name: Web Application
description: Parents receive a web application that offers information and support until the age of 2.
arm group label: INTNIC
criteria: 
gender: All
minimum age: N/A
maximum age: 32 Weeks
healthy volunteers: No
last name: Marie-Rose Van Hoestenberghe, MD.
role: Principal Investigator
affiliation: Ziekenhuis Oost-Limburg
last name: Marie-Rose Van Hoestenberghe, MD.
phone: +32 89 32 76 33
email: marie-rose.vanhoestenberghe@zol.be
facility: 
status: Recruiting
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Ziekenhuis Oost-Limburg
investigator full name: Marie-Rose Van Hoestenberghe, MD
investigator title: Neonatologist
mesh term: Premature Birth
sharing ipd: No