xml: <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/NCT05990582</url>
    </required_header>
    <id_info>
      <org_study_id>NL82197.029.22</org_study_id>
      <nct_id>NCT05990582</nct_id>
    </id_info>
    <brief_title>The Alkmaar MLPTI Cohort Study: Outcomes at 9 Years</brief_title>
    <official_title>Neurodevelopmental Outcomes and Morbidities of Moderate and Late Preterm Children at the Age of 9 Years -The Alkmaar MLPTI Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Noordwest Ziekenhuisgroep</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Noordwest Ziekenhuisgroep</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Objective of the study:&#xD;
  &#xD;
        To examine cognition, motor function, executive functions, speech and language development,&#xD;
        behaviour, psychosocial functioning,academic achievement, physical morbidities and growth of&#xD;
        MLPTI at the age of 9 years and correlate this with BSID-III-NL scores,growth parameters and&#xD;
        body composition at the age of 2 years.&#xD;
  &#xD;
        Study design:&#xD;
  &#xD;
        This study will be a prospective open, non-therapeutic exploratory cohort study and can be&#xD;
        seen as a continuation on the study with protocol identification number NL50800.094.14,&#xD;
        performed in the NWZ Alkmaar between 2014 and 2016. This was a study on growth and&#xD;
        neurodevelopment of MLPTI in the first 2 years of life.&#xD;
  &#xD;
        Study population:&#xD;
  &#xD;
        The study population is a group of 200 moderate and late preterm children who were born in&#xD;
        the NWZ Alkmaar between 2014 and 2016. 100 of these children participated in the&#xD;
        aforementioned study on growth and neurodevelopment at the age of 2 years. The oldest&#xD;
        children in this group will reach the age of 9 years in 2023. Brothers/sisters/friends of&#xD;
        these children aged between 8 and 10 will be asked as control group (n=50).&#xD;
  &#xD;
        Primary study parameters/outcome of the study:&#xD;
  &#xD;
        The main study parameters are the IQ-scores of the WISC-V, the motoric scores of the&#xD;
        Movement-ABC, the executive functions of the EMMA Toolbox, the presence of morbidities, the&#xD;
        growth pattern and the mean blood pressure at 9 years of age.&#xD;
  &#xD;
        Secondary study parameters/outcome of the study:&#xD;
  &#xD;
        Secondary outcome parameters are the he behavioural and psychosocial outcomes of the CBCL and&#xD;
        the SDQ scores, speech-and language-developmental scores of the CELF-5-NL and CCC-2-NL, MCH&#xD;
        Feeding Scale and Teacher Report Form (TRF) scores. Other outcome parameters are the relation&#xD;
        between the 9-year outcomes and the BSID-III scores at the age of 2, and the differences&#xD;
        between the MLPTI and the control group. Furthermore, we aim to determine the relation&#xD;
        between growth and body composition in the first two years of life and the waist&#xD;
        circumference, growth parameters and blood pressure at the age of 9 years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        SUMMARY Rationale: Recent studies indicate that moderate and late preterm infants (MLPTI,&#xD;
        gestational age (GA) 32-36 weeks) are at risk of lower IQ scores, behavioural and attention&#xD;
        problems and academic underachievement at the age of 6 to 10 years. These recent findings of&#xD;
        impaired outcomes above the age of 6 contrast with earlier studies that suggested that&#xD;
        outcomes of MLPTI are comparable to those of full-term children. However, since the number of&#xD;
        studies performed on MLPTI above 6 years of age is limited and show different results, the&#xD;
        developmental outcomes of MLPTI remains a subject of debate and more research to this subject&#xD;
        is warranted.&#xD;
  &#xD;
        In addition, one recent study correlated impaired behavioural outcomes and lower IQ-scores at&#xD;
        the age of 6 with the attentional and language scores of a Bayley Scales of Infant and&#xD;
        Toddler Development (BSID-III) performed at the age of 1.5 to 2 years. This relation,&#xD;
        however, is not confirmed in other studies. More research is therefore necessary to clarify&#xD;
        the predictive value of these screening methods in early detection of impaired outcomes&#xD;
        during school age, and to examine whether a longer follow-up could thereby help to prevent&#xD;
        these problems.&#xD;
  &#xD;
        Objective: To assess neurodevelopmental outcomes (including neurocognitive, motor, language,&#xD;
        behavioral, and academic functioning), growth and morbidities in MLPTI children at the age of&#xD;
        9 born in the NWZ Alkmaar, and compare these outcomes to those of a sex and age-matched&#xD;
        control group of friends of MLPTI children born at uncomplicated full term gestational age.&#xD;
  &#xD;
        Study design: This study will be a prospective open, non-therapeutic exploratory cohort study&#xD;
        and can be seen as a continuation on the study with protocol identification number&#xD;
        NL50800.094.14, performed in the NWZ Alkmaar between 2014 and 2016. That study described&#xD;
        growth, body composition and neurodevelopmental outcome of MLPTI in the first 2 years of&#xD;
        life.&#xD;
  &#xD;
        Study population: The study population is a group of 200 moderate and late preterm children&#xD;
        who were born in the NWZ Alkmaar between 2014 and 2016. A total number of hundred children&#xD;
        participated in the aforementioned study on growth and neurodevelopment at the age of 2&#xD;
        years. The oldest children of this cohort will reach the age of 9 years in January 2023. Sex&#xD;
        and age-matched friends of these children whom are also 9 years old will be examined as&#xD;
        control group of same aged peers (n=70).&#xD;
  &#xD;
        Intervention: Parents will be asked to fill in five widely used questionnaires, including the&#xD;
        Child Behaviour Checklist (CBCL), Strengths and Difficulties Questionnaire (SDQ), Childrens&#xD;
        Communication Checklist (CCC-2-NL), Montreal Childrens Hospital Feeding Scale (MCH Feeding&#xD;
        Scale) and a custom made questionnaire on morbidities. Teachers will be asked to complete the&#xD;
        Teacher report form (TRF)), which is a version of the CBCL adapted for teachers. Children&#xD;
        will visit the outpatient clinic once for neurodevelopmental assessment, including the&#xD;
        Wechsler Intelligence Scale of Development for Children (WISC-V-NL) to assess intelligence&#xD;
        (IQ), the EMMA-Toolbox to assess neurocognitive functioning, the Movement ABC (MABC-II-NL) to&#xD;
        assess motor function, and subtests of the Clinical Evaluation of Language Fundamentals&#xD;
        (CELF-5-NL) to assess language development. Furthermore, academic achievement will be&#xD;
        assessed using existing data collected at school as part of the student monitoring system&#xD;
        (National Institute for Educational Measurement (CITO)). During the same single visit,&#xD;
        length, weight, waist circumference and blood pressure will be measured to analyse the body&#xD;
        composition.&#xD;
  &#xD;
        Main study parameters/endpoints: To examine neurodevelopmental outcomes (including&#xD;
        neurocognitive, motor, language, and (eating-)behavioral function, and academic achievement),&#xD;
        growth and morbidities in MLPTI children at the age of 9 born in the Noordwest Ziekenhuis,&#xD;
        location Alkmaar, and compare them with a control group of 9 year old friends born at full&#xD;
        term.&#xD;
  &#xD;
        Secondary study parameters/outcome of the study:&#xD;
  &#xD;
        Secondary outcome parameters are the he behavioural and psychosocial outcomes of the CBCL and&#xD;
        the SDQ scores, speech-and language-developmental scores of the CELF-5-NL and CCC-2-NL, The&#xD;
        Montreal Children Hospital feeding Scale and Teacher Report Form scores. Other outcome&#xD;
        parameters are the relation between the 9-year outcomes and the BSID-III scores at the age of&#xD;
        2, and the differences between the MLPTI and the control group. Furthermore, we aim to&#xD;
        determine the relation between growth and body composition in the first two years of life and&#xD;
        the waist circumference, growth parameters and blood pressure at the age of 9 years.&#xD;
  &#xD;
        .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 6, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2025</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>
      <intervention_model_description>Outcomes of a group of preterm born children are compared to a group of children born at term.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Full scale IQ</measure>
      <time_frame>At 9 years of age</time_frame>
      <description>The primary index scores and the FSIQ are on a standard score metric with a mean of 100 and an SD of 15. The primary index scores range from 45 to 155; the FSIQ ranges from 40 to 160.&#xD;
  For both the primary index scores and the FSIQ, scores ranging from 90 to 109 are typically considered average</description>
    </primary_outcome>
    <primary_outcome>
      <measure>M-ABC score</measure>
      <time_frame>At 9 years of age</time_frame>
      <description>Standard Score: Total and percentile Total score 0, percentile 96-100 (high) Totalscore 4, percentile 54 (moderate) Totalscore 10, percentile 15 (consider help/intervention) totalscore 13,5, percentile 5 (intervention needed)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Executive functions on Emma-Toolbox</measure>
      <time_frame>At 9 years of age</time_frame>
      <description>Processing speed &amp; Control Verbal Memory Visual memory Verbal working Memory Visual Working Memory Interpretation: Cortex. 2021 Oct;143:12-28. doi: 10.1016/j.cortex.2021.06.011. Epub 2021 Jul 14 Visuomotoric integration.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence of Morbidities</measure>
      <time_frame>At 9 years of age</time_frame>
      <description>This questionary scores the following morbities in percentages (numbers of participants with): re-admission in hospital, amount of infections, eczema, astma, speech and developmental problems, medication use, operations</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Measurements of growth</measure>
      <time_frame>At 9 years of age</time_frame>
      <description>Length, weight, head and abdominal circumference are measured in cm. Parental height will be measured in cm.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood Pressure at 9 years of age</measure>
      <time_frame>At 9 years of age</time_frame>
      <description>Systolic bloodpressure in mmHg, range 5-200 Diastolic blood pressure in mmHg p-value is conducted for age.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Behavioural and psychosocial outcomes of the CBCL</measure>
      <time_frame>At 9 years of age</time_frame>
      <description>Each item is scored using the scale: 0 = not true (as far as you know); 1 = somewhat or sometimes true; 2 = very true or often true. A total score of total behavorial problems is calculated and divided ingeTotal Score of behaviorial problems divided in internlizing behavorial problems and external behaviorial problems. A total T- score above 50 indicates that there are more problems than de controlgroup. the higher the score the more problems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Speech- and language-developmental scores on CELF-5-NL</measure>
      <time_frame>At 9 years of age</time_frame>
      <description>Standard Score: This scores are derived from the total raw scores for each test and are on a normalized score scale that has a mean of 10 and a standard deviation (SD) of 3. A scaled score of 10 describes the average of a given age group. Scores of 7 and 13 are 1 SD below and above the mean, respectively The Children's Communication Checklist-2 U.S. Edition is a parent or caregiver rating scale based on the extensive research of author, Dr. Dorothy Bishop. CCC-2 helps rate aspects of communication, screens for general language, and identifies pragmatic language impairment. Domains that are tested is language: speech, syntax, sematics and coherence and pragmatics in scores.&#xD;
  These scores are derived from the total raw scores for each test and are on a normalized score scale that has a mean of 10 and a standard deviation (SD) of 3 of 10 describes the average of a given age group. Scores of 7 and 13 are 1 SD below and above the mean, respectively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Children's Communication List CCC-2-NL</measure>
      <time_frame>At 9 years of age</time_frame>
      <description>The Children's Communication Checklist-2 U.S. Edition is a parent or caregiver rating scale based on the extensive research of author, Dr. Dorothy Bishop. CCC-2 helps rate aspects of communication, screens for general language, and identifies pragmatic language impairment. Domains that are tested is language: speech, syntax, sematics and coherence and pragmatics in scores.&#xD;
  These scores are derived from the total raw scores for each test and are on a normalized score scale that has a mean of 10 and a standard deviation (SD) of 3 of 10 describes the average of a given age group. Scores of 7 and 13 are 1 SD below and above the mean, respectively</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Strengths and Difficulties Questionnaire (SDQ)</measure>
      <time_frame>At age of 9 years</time_frame>
      <description>The SDQ is a brief behavioural screening questionnaire about 2-17 year olds. It includes between one and three of the following components:&#xD;
  A) 25 items on psychological attributes.&#xD;
  All versions of the SDQ ask about 25 attributes, some positive and others negative. These 25 items are divided between 5 scales:&#xD;
  emotional symptoms (5 items)&#xD;
  conduct problems (5 items)&#xD;
  hyperactivity/inattention (5 items)&#xD;
  peer relationship problems (5 items)&#xD;
  prosocial behaviour (5 items) A total score kan be calculated. A the T-score &lt; 80 is considered as normal, 80-90 might indicate small problems,, a score &gt; 90 indicates serious problems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Teacher Report Form (TRH)</measure>
      <time_frame>At 9 years of age</time_frame>
      <description>This is the CBCL test filled in by the teacher. Each item is scored using the scale: 0 = not true (as far as you know); 1 = somewhat or sometimes true; 2 = very true or often true. A total score of total behavorial problems is calculated and divided ingeTotal Score of behaviorial problems divided in internlizing behavorial problems and external behaviorial problems. A total T- score above 50 indicates that there are more problems than de controlgroup. the higher the score the more problems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montreal Childrens Hospital Feeding Scale (MCH)</measure>
      <time_frame>At 9 years of age</time_frame>
      <description>The Montreal Children's Hospital Feeding Scale [MCH-Feeding Scale]) designed to identify feeding problems in children.&#xD;
  Normal range = raw score 0-45 [T-score 35-60], mild difficulties = 46-52 [T-score 61-65], moderate 53-58 [T-score 66-70], severe &gt;=59 [T-score &gt;70].</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Preterm Birth</condition>
    <condition>Developmental Delay</condition>
    <condition>Growth Delay</condition>
    <arm_group>
      <arm_group_label>MLPTI Cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group of 9 year old children born between 32 and 36 weeks of gestational age</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control cohort</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group of 9 year old children born at term</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>CBCL</intervention_name>
      <description>A questionnaire on behaviour</description>
      <arm_group_label>Control cohort</arm_group_label>
      <arm_group_label>MLPTI Cohort</arm_group_label>
      <other_name>Child Behaviour Checklist</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>SDQ</intervention_name>
      <description>A questionnaire on behaviour</description>
      <arm_group_label>Control cohort</arm_group_label>
      <arm_group_label>MLPTI Cohort</arm_group_label>
      <other_name>Strength and Difficulties Questionnaire</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>CCC-2-NL</intervention_name>
      <description>A questionnaire on communcational skills</description>
      <arm_group_label>Control cohort</arm_group_label>
      <arm_group_label>MLPTI Cohort</arm_group_label>
      <other_name>Children's Communication Checklist</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>MCH Feeding scale</intervention_name>
      <description>A questionnaire on feeding problems</description>
      <arm_group_label>Control cohort</arm_group_label>
      <arm_group_label>MLPTI Cohort</arm_group_label>
      <other_name>Montreal Children's Hospital Feeding Scale</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>TRF</intervention_name>
      <description>A questionnaire on behaviour</description>
      <arm_group_label>Control cohort</arm_group_label>
      <arm_group_label>MLPTI Cohort</arm_group_label>
      <other_name>Teacher report form</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>WISC-5-NL</intervention_name>
      <description>An IQ test for children</description>
      <arm_group_label>Control cohort</arm_group_label>
      <arm_group_label>MLPTI Cohort</arm_group_label>
      <other_name>Wechsler Intelligence Scale of Development for Children</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Movement ABC</intervention_name>
      <description>A test to assess motor function</description>
      <arm_group_label>Control cohort</arm_group_label>
      <arm_group_label>MLPTI Cohort</arm_group_label>
      <other_name>MABC-II-NL</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>CELF-5-NL</intervention_name>
      <description>A test to assess language development</description>
      <arm_group_label>Control cohort</arm_group_label>
      <arm_group_label>MLPTI Cohort</arm_group_label>
      <other_name>Clinical Evaluation of Language Fundamentals</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Emma Toolbox</intervention_name>
      <description>Test of executive functions</description>
      <arm_group_label>Control cohort</arm_group_label>
      <arm_group_label>MLPTI Cohort</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          In order to be eligible to participate in this study, a subject must meet all the following&#xD;
          criteria:&#xD;
  &#xD;
            -  The participant is born in or transferred to the NWZ Alkmaar between January 1st, 2014&#xD;
               and April 18th, 2016 (the time in which the participants of trial NL50800.094.14 were&#xD;
               born).&#xD;
  &#xD;
            -  The participant born at a gestational age from 32 to 35+6 weeks.&#xD;
  &#xD;
            -  Both parents of the participant have given informed consent to participate in the 9&#xD;
               years trial&#xD;
  &#xD;
          In order to be eligible to participate in the control group of this study, a subject must&#xD;
          meet all the following criteria:&#xD;
  &#xD;
            -  The participant is 9 years old when participating in this study and is a friend or&#xD;
               classmate of the included MLPTI.&#xD;
  &#xD;
            -  Both parents of the participant have given informed consent for the participation of&#xD;
               the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          A potential subject who meets any of the following criteria will be excluded from&#xD;
          participation in this study:&#xD;
  &#xD;
            -  The participant's parents are not able to fill out questionnaires or perform tests in&#xD;
               Dutch.&#xD;
  &#xD;
            -  The participant has a severe developmental or genetic disorder and is thereby not able&#xD;
               to perform the tests.&#xD;
  &#xD;
            -  The participant is not able to come to the outpatient clinic to do the tests.&#xD;
  &#xD;
          A potential subject who meets any of the following criteria will be excluded from&#xD;
          participation in this study as part of the control group:&#xD;
  &#xD;
            -  The participant is born with a GA &lt; 37 weeks.&#xD;
  &#xD;
            -  The participant has a severe developmental or genetic disorder and is thereby not able&#xD;
               to perform the tests.&#xD;
  &#xD;
            -  The participant had complications after birth (e.g. admission at a Neonatal ward)&#xD;
  &#xD;
            -  The participant needs special education&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>9 Years</minimum_age>
      <maximum_age>9 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>METC AUMC</last_name>
      <role>Study Chair</role>
      <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Noordwest Ziekenhuisgroep</name>
        <address>
          <city>Alkmaar</city>
          <zip>1815JD</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Noordwest Ziekenhuisgroep</investigator_affiliation>
      <investigator_full_name>F. (Femke) de Groof</investigator_full_name>
      <investigator_title>Principal Investigator, MD, PhD</investigator_title>
    </responsible_party>
    <keyword>Moderate and late preterm infants</keyword>
    <keyword>Neurodevelopmental outcomes</keyword>
    <keyword>Growth</keyword>
    <keyword>Morbidities</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>
  
  
text: 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/NCT05990582
  org study id: NL82197.029.22
  nct id: NCT05990582
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Objective of the study:
  
        To examine cognition, motor function, executive functions, speech and language development,
        behaviour, psychosocial functioning,academic achievement, physical morbidities and growth of
        MLPTI at the age of 9 years and correlate this with BSID-III-NL scores,growth parameters and
        body composition at the age of 2 years.
  
        Study design:
  
        This study will be a prospective open, non-therapeutic exploratory cohort study and can be
        seen as a continuation on the study with protocol identification number NL50800.094.14,
        performed in the NWZ Alkmaar between 2014 and 2016. This was a study on growth and
        neurodevelopment of MLPTI in the first 2 years of life.
  
        Study population:
  
        The study population is a group of 200 moderate and late preterm children who were born in
        the NWZ Alkmaar between 2014 and 2016. 100 of these children participated in the
        aforementioned study on growth and neurodevelopment at the age of 2 years. The oldest
        children in this group will reach the age of 9 years in 2023. Brothers/sisters/friends of
        these children aged between 8 and 10 will be asked as control group (n=50).
  
        Primary study parameters/outcome of the study:
  
        The main study parameters are the IQ-scores of the WISC-V, the motoric scores of the
        Movement-ABC, the executive functions of the EMMA Toolbox, the presence of morbidities, the
        growth pattern and the mean blood pressure at 9 years of age.
  
        Secondary study parameters/outcome of the study:
  
        Secondary outcome parameters are the he behavioural and psychosocial outcomes of the CBCL and
        the SDQ scores, speech-and language-developmental scores of the CELF-5-NL and CCC-2-NL, MCH
        Feeding Scale and Teacher Report Form (TRF) scores. Other outcome parameters are the relation
        between the 9-year outcomes and the BSID-III scores at the age of 2, and the differences
        between the MLPTI and the control group. Furthermore, we aim to determine the relation
        between growth and body composition in the first two years of life and the waist
        circumference, growth parameters and blood pressure at the age of 9 years.
  SUMMARY Rationale: Recent studies indicate that moderate and late preterm infants (MLPTI,
        gestational age (GA) 32-36 weeks) are at risk of lower IQ scores, behavioural and attention
        problems and academic underachievement at the age of 6 to 10 years. These recent findings of
        impaired outcomes above the age of 6 contrast with earlier studies that suggested that
        outcomes of MLPTI are comparable to those of full-term children. However, since the number of
        studies performed on MLPTI above 6 years of age is limited and show different results, the
        developmental outcomes of MLPTI remains a subject of debate and more research to this subject
        is warranted.
  
        In addition, one recent study correlated impaired behavioural outcomes and lower IQ-scores at
        the age of 6 with the attentional and language scores of a Bayley Scales of Infant and
        Toddler Development (BSID-III) performed at the age of 1.5 to 2 years. This relation,
        however, is not confirmed in other studies. More research is therefore necessary to clarify
        the predictive value of these screening methods in early detection of impaired outcomes
        during school age, and to examine whether a longer follow-up could thereby help to prevent
        these problems.
  
        Objective: To assess neurodevelopmental outcomes (including neurocognitive, motor, language,
        behavioral, and academic functioning), growth and morbidities in MLPTI children at the age of
        9 born in the NWZ Alkmaar, and compare these outcomes to those of a sex and age-matched
        control group of friends of MLPTI children born at uncomplicated full term gestational age.
  
        Study design: This study will be a prospective open, non-therapeutic exploratory cohort study
        and can be seen as a continuation on the study with protocol identification number
        NL50800.094.14, performed in the NWZ Alkmaar between 2014 and 2016. That study described
        growth, body composition and neurodevelopmental outcome of MLPTI in the first 2 years of
        life.
  
        Study population: The study population is a group of 200 moderate and late preterm children
        who were born in the NWZ Alkmaar between 2014 and 2016. A total number of hundred children
        participated in the aforementioned study on growth and neurodevelopment at the age of 2
        years. The oldest children of this cohort will reach the age of 9 years in January 2023. Sex
        and age-matched friends of these children whom are also 9 years old will be examined as
        control group of same aged peers (n=70).
  
        Intervention: Parents will be asked to fill in five widely used questionnaires, including the
        Child Behaviour Checklist (CBCL), Strengths and Difficulties Questionnaire (SDQ), Childrens
        Communication Checklist (CCC-2-NL), Montreal Childrens Hospital Feeding Scale (MCH Feeding
        Scale) and a custom made questionnaire on morbidities. Teachers will be asked to complete the
        Teacher report form (TRF)), which is a version of the CBCL adapted for teachers. Children
        will visit the outpatient clinic once for neurodevelopmental assessment, including the
        Wechsler Intelligence Scale of Development for Children (WISC-V-NL) to assess intelligence
        (IQ), the EMMA-Toolbox to assess neurocognitive functioning, the Movement ABC (MABC-II-NL) to
        assess motor function, and subtests of the Clinical Evaluation of Language Fundamentals
        (CELF-5-NL) to assess language development. Furthermore, academic achievement will be
        assessed using existing data collected at school as part of the student monitoring system
        (National Institute for Educational Measurement (CITO)). During the same single visit,
        length, weight, waist circumference and blood pressure will be measured to analyse the body
        composition.
  
        Main study parameters/endpoints: To examine neurodevelopmental outcomes (including
        neurocognitive, motor, language, and (eating-)behavioral function, and academic achievement),
        growth and morbidities in MLPTI children at the age of 9 born in the Noordwest Ziekenhuis,
        location Alkmaar, and compare them with a control group of 9 year old friends born at full
        term.
  
        Secondary study parameters/outcome of the study:
  
        Secondary outcome parameters are the he behavioural and psychosocial outcomes of the CBCL and
        the SDQ scores, speech-and language-developmental scores of the CELF-5-NL and CCC-2-NL, The
        Montreal Children Hospital feeding Scale and Teacher Report Form scores. Other outcome
        parameters are the relation between the 9-year outcomes and the BSID-III scores at the age of
        2, and the differences between the MLPTI and the control group. Furthermore, we aim to
        determine the relation between growth and body composition in the first two years of life and
        the waist circumference, growth parameters and blood pressure at the age of 9 years.
  
        .
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Outcomes of a group of preterm born children are compared to a group of children born at term.
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Full scale IQ
  time frame: At 9 years of age
  description: The primary index scores and the FSIQ are on a standard score metric with a mean of 100 and an SD of 15. The primary index scores range from 45 to 155; the FSIQ ranges from 40 to 160.
  For both the primary index scores and the FSIQ, scores ranging from 90 to 109 are typically considered average
  measure: M-ABC score
  time frame: At 9 years of age
  description: Standard Score: Total and percentile Total score 0, percentile 96-100 (high) Totalscore 4, percentile 54 (moderate) Totalscore 10, percentile 15 (consider help/intervention) totalscore 13,5, percentile 5 (intervention needed)
  measure: Executive functions on Emma-Toolbox
  time frame: At 9 years of age
  description: Processing speed & Control Verbal Memory Visual memory Verbal working Memory Visual Working Memory Interpretation: Cortex. 2021 Oct;143:12-28. doi: 10.1016/j.cortex.2021.06.011. Epub 2021 Jul 14 Visuomotoric integration.
  measure: Prevalence of Morbidities
  time frame: At 9 years of age
  description: This questionary scores the following morbities in percentages (numbers of participants with): re-admission in hospital, amount of infections, eczema, astma, speech and developmental problems, medication use, operations
  measure: Measurements of growth
  time frame: At 9 years of age
  description: Length, weight, head and abdominal circumference are measured in cm. Parental height will be measured in cm.
  measure: Blood Pressure at 9 years of age
  time frame: At 9 years of age
  description: Systolic bloodpressure in mmHg, range 5-200 Diastolic blood pressure in mmHg p-value is conducted for age.
  measure: Behavioural and psychosocial outcomes of the CBCL
  time frame: At 9 years of age
  description: Each item is scored using the scale: 0 = not true (as far as you know); 1 = somewhat or sometimes true; 2 = very true or often true. A total score of total behavorial problems is calculated and divided ingeTotal Score of behaviorial problems divided in internlizing behavorial problems and external behaviorial problems. A total T- score above 50 indicates that there are more problems than de controlgroup. the higher the score the more problems.
  measure: Speech- and language-developmental scores on CELF-5-NL
  time frame: At 9 years of age
  description: Standard Score: This scores are derived from the total raw scores for each test and are on a normalized score scale that has a mean of 10 and a standard deviation (SD) of 3. A scaled score of 10 describes the average of a given age group. Scores of 7 and 13 are 1 SD below and above the mean, respectively The Children's Communication Checklist-2 U.S. Edition is a parent or caregiver rating scale based on the extensive research of author, Dr. Dorothy Bishop. CCC-2 helps rate aspects of communication, screens for general language, and identifies pragmatic language impairment. Domains that are tested is language: speech, syntax, sematics and coherence and pragmatics in scores.
  These scores are derived from the total raw scores for each test and are on a normalized score scale that has a mean of 10 and a standard deviation (SD) of 3 of 10 describes the average of a given age group. Scores of 7 and 13 are 1 SD below and above the mean, respectively
  measure: Children's Communication List CCC-2-NL
  time frame: At 9 years of age
  description: The Children's Communication Checklist-2 U.S. Edition is a parent or caregiver rating scale based on the extensive research of author, Dr. Dorothy Bishop. CCC-2 helps rate aspects of communication, screens for general language, and identifies pragmatic language impairment. Domains that are tested is language: speech, syntax, sematics and coherence and pragmatics in scores.
  These scores are derived from the total raw scores for each test and are on a normalized score scale that has a mean of 10 and a standard deviation (SD) of 3 of 10 describes the average of a given age group. Scores of 7 and 13 are 1 SD below and above the mean, respectively
  measure: The Strengths and Difficulties Questionnaire (SDQ)
  time frame: At age of 9 years
  description: The SDQ is a brief behavioural screening questionnaire about 2-17 year olds. It includes between one and three of the following components:
  A) 25 items on psychological attributes.
  All versions of the SDQ ask about 25 attributes, some positive and others negative. These 25 items are divided between 5 scales:
  emotional symptoms (5 items)
  conduct problems (5 items)
  hyperactivity/inattention (5 items)
  peer relationship problems (5 items)
  prosocial behaviour (5 items) A total score kan be calculated. A the T-score < 80 is considered as normal, 80-90 might indicate small problems,, a score > 90 indicates serious problems.
  measure: Teacher Report Form (TRH)
  time frame: At 9 years of age
  description: This is the CBCL test filled in by the teacher. Each item is scored using the scale: 0 = not true (as far as you know); 1 = somewhat or sometimes true; 2 = very true or often true. A total score of total behavorial problems is calculated and divided ingeTotal Score of behaviorial problems divided in internlizing behavorial problems and external behaviorial problems. A total T- score above 50 indicates that there are more problems than de controlgroup. the higher the score the more problems.
  measure: Montreal Childrens Hospital Feeding Scale (MCH)
  time frame: At 9 years of age
  description: The Montreal Children's Hospital Feeding Scale [MCH-Feeding Scale]) designed to identify feeding problems in children.
  Normal range = raw score 0-45 [T-score 35-60], mild difficulties = 46-52 [T-score 61-65], moderate 53-58 [T-score 66-70], severe >=59 [T-score >70].
  arm group label: MLPTI Cohort
  arm group type: Experimental
  description: Group of 9 year old children born between 32 and 36 weeks of gestational age
  arm group label: Control cohort
  arm group type: Active Comparator
  description: Group of 9 year old children born at term
  intervention type: Diagnostic Test
  intervention name: CBCL
  description: A questionnaire on behaviour
  arm group label: Control cohort
  arm group label: MLPTI Cohort
  other name: Child Behaviour Checklist
  intervention type: Diagnostic Test
  intervention name: SDQ
  description: A questionnaire on behaviour
  arm group label: Control cohort
  arm group label: MLPTI Cohort
  other name: Strength and Difficulties Questionnaire
  intervention type: Diagnostic Test
  intervention name: CCC-2-NL
  description: A questionnaire on communcational skills
  arm group label: Control cohort
  arm group label: MLPTI Cohort
  other name: Children's Communication Checklist
  intervention type: Diagnostic Test
  intervention name: MCH Feeding scale
  description: A questionnaire on feeding problems
  arm group label: Control cohort
  arm group label: MLPTI Cohort
  other name: Montreal Children's Hospital Feeding Scale
  intervention type: Diagnostic Test
  intervention name: TRF
  description: A questionnaire on behaviour
  arm group label: Control cohort
  arm group label: MLPTI Cohort
  other name: Teacher report form
  intervention type: Diagnostic Test
  intervention name: WISC-5-NL
  description: An IQ test for children
  arm group label: Control cohort
  arm group label: MLPTI Cohort
  other name: Wechsler Intelligence Scale of Development for Children
  intervention type: Diagnostic Test
  intervention name: Movement ABC
  description: A test to assess motor function
  arm group label: Control cohort
  arm group label: MLPTI Cohort
  other name: MABC-II-NL
  intervention type: Diagnostic Test
  intervention name: CELF-5-NL
  description: A test to assess language development
  arm group label: Control cohort
  arm group label: MLPTI Cohort
  other name: Clinical Evaluation of Language Fundamentals
  intervention type: Diagnostic Test
  intervention name: Emma Toolbox
  description: Test of executive functions
  arm group label: Control cohort
  arm group label: MLPTI Cohort
  criteria: 
  gender: All
  minimum age: 9 Years
  maximum age: 9 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: METC AUMC
  role: Study Chair
  affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  facility: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Noordwest Ziekenhuisgroep
  investigator full name: F. (Femke) de Groof
  investigator title: Principal Investigator, MD, PhD
  mesh term: Premature Birth
  sharing ipd: No