<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/NCT01683812</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00003465</org_study_id>
    <nct_id>NCT01683812</nct_id>
  </id_info>
  <brief_title>Cranial Cup Use for Correction of Head Shape Deformities</brief_title>
  <official_title>Cranial Cup Use for the Correction of Positional Head Shape Deformities in Hospitalized Premature Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this descriptive study is to provide information on the feasibility of using&#xD;
      the cranial cup, a new positioning device, in a small sample of prematurely born infants with&#xD;
      elongated head shapes as a result of laying on their abdomens, during the convalescent phase&#xD;
      of their hospitalizations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The cranial cup is a non-invasive, non-restrictive, adjustable orthotic device that grows&#xD;
      with the infant and maintains proper body alignment while promoting normal head shape&#xD;
      development. While the cranial cup is not yet FDA approved, it is considered a&#xD;
      non-significant medical device and it has successfully corrected asymmetric positional head&#xD;
      shape deformities in hundreds of healthy newborns less than 4 months of age cared for by the&#xD;
      Children's Hospital Boston outpatient plagiocephaly clinic. Additionally preliminary analysis&#xD;
      of a prospective randomized controlled trial currently underway suggests that the cranial cup&#xD;
      may be useful in prevention of positional head shape deformity in a cohort of hospitalized&#xD;
      infants of varying gestational ages. However, the cranial cup has never been used for&#xD;
      correction of the most common form of positional head shape deformity in hospitalized&#xD;
      premature infants; namely dolichocephaly. Thus, the purpose of this descriptive study is to&#xD;
      provide information on the feasibility of using the cranial cup in a small sample of&#xD;
      prematurely born infants with dolichocephaly during the convalescent phase of their&#xD;
      hospitalizations. Information obtained from this descriptive study will be used to determine&#xD;
      if a larger investigation using the cranial cup is warranted in this specific patient&#xD;
      population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility and Safety</measure>
    <time_frame>Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days</time_frame>
    <description>Nurses will complete daily logs indicating the number of desaturation events (oxygen saturation of &lt; 90 percent for infant corrected to full term or &lt; 87 percent for a premature infant for &gt; 10 seconds) and emesis events (regurgitation of breast milk or formula) during cranial cup device use. The cup's designated use is for at least 12 hours per day. Study duration is at least 14 days and can continue until the infant is discharged. Comparisons will be made for the number of desaturation events and emesis during data analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cranial Measurement Description</measure>
    <time_frame>Using head measurements obtained at timepoint 1 enrollment (baseline, day 1) and at timepoint 2 discharge (14-120 days)</time_frame>
    <description>To describe infant head shape, the study will use cranial measurements and laser head scans in a sample of prematurely born Neonatal Intensive Care (NICU) or Special Care Nursery (SCN) patients with dolichocephaly. Cranial measurement used is cranial index, an objective measure that quantifies head shape by dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Measurements and scans will be taken directly following study enrollment and discharge to document head shape pre and post intervention. The discharge measure will be obtained at approximately 2 weeks-4 months of age at hospital discharge.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Dolichocephaly</condition>
  <arm_group>
    <arm_group_label>Cranial Cup Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cranial Cup</intervention_name>
    <description>Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.</description>
    <arm_group_label>Cranial Cup Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born at &lt; or equal to 35 weeks gestation&#xD;
&#xD;
          -  Cleared for participation by healthcare team&#xD;
&#xD;
          -  Estimated minimum length of stay &gt;14 days&#xD;
&#xD;
          -  Weight &gt;1000 grams (at enrollment)&#xD;
&#xD;
          -  Dolichocephalic head shape deformity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to maintain airway patency (anatomical problem)&#xD;
&#xD;
          -  Craniofacial anomaly or scalp device, drain or shunt&#xD;
&#xD;
          -  Craniosynostosis&#xD;
&#xD;
          -  Severe parturitional head shape deformity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michele DeGrazia, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aimee Knorr, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Winchester Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winchester Hospital</name>
      <address>
        <city>Winchester</city>
        <state>Massachusetts</state>
        <zip>01890</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <results_first_submitted>December 15, 2016</results_first_submitted>
  <results_first_submitted_qc>February 9, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 29, 2017</results_first_posted>
  <last_update_submitted>February 9, 2017</last_update_submitted>
  <last_update_submitted_qc>February 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Michele DeGrazia</investigator_full_name>
    <investigator_title>Director of Nursing Research NICU</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cranial Cup Arm</title>
          <description>Single arm&#xD;
Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cranial Cup Arm</title>
          <description>Single arm&#xD;
Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Corrected Gestational Age at Enrollment</description>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.6" lower_limit="30" upper_limit="44.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility and Safety</title>
        <description>Nurses will complete daily logs indicating the number of desaturation events (oxygen saturation of &lt; 90 percent for infant corrected to full term or &lt; 87 percent for a premature infant for &gt; 10 seconds) and emesis events (regurgitation of breast milk or formula) during cranial cup device use. The cup's designated use is for at least 12 hours per day. Study duration is at least 14 days and can continue until the infant is discharged. Comparisons will be made for the number of desaturation events and emesis during data analysis.</description>
        <time_frame>Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cranial Cup Arm</title>
            <description>Single arm&#xD;
Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility and Safety</title>
          <description>Nurses will complete daily logs indicating the number of desaturation events (oxygen saturation of &lt; 90 percent for infant corrected to full term or &lt; 87 percent for a premature infant for &gt; 10 seconds) and emesis events (regurgitation of breast milk or formula) during cranial cup device use. The cup's designated use is for at least 12 hours per day. Study duration is at least 14 days and can continue until the infant is discharged. Comparisons will be made for the number of desaturation events and emesis during data analysis.</description>
          <units>count</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>desaturation events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="0" upper_limit="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>emesis events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cranial Measurement Description</title>
        <description>To describe infant head shape, the study will use cranial measurements and laser head scans in a sample of prematurely born Neonatal Intensive Care (NICU) or Special Care Nursery (SCN) patients with dolichocephaly. Cranial measurement used is cranial index, an objective measure that quantifies head shape by dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Measurements and scans will be taken directly following study enrollment and discharge to document head shape pre and post intervention. The discharge measure will be obtained at approximately 2 weeks-4 months of age at hospital discharge.</description>
        <time_frame>Using head measurements obtained at timepoint 1 enrollment (baseline, day 1) and at timepoint 2 discharge (14-120 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cranial Cup Arm</title>
            <description>Single arm&#xD;
Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.</description>
          </group>
        </group_list>
        <measure>
          <title>Cranial Measurement Description</title>
          <description>To describe infant head shape, the study will use cranial measurements and laser head scans in a sample of prematurely born Neonatal Intensive Care (NICU) or Special Care Nursery (SCN) patients with dolichocephaly. Cranial measurement used is cranial index, an objective measure that quantifies head shape by dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Measurements and scans will be taken directly following study enrollment and discharge to document head shape pre and post intervention. The discharge measure will be obtained at approximately 2 weeks-4 months of age at hospital discharge.</description>
          <units>cranial index %</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.5" lower_limit="69.8" upper_limit="83.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Cranial Cup Arm</title>
          <description>Single arm&#xD;
Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michele DeGrazia PhD, RN, NNP-BC, FAAN</name_or_title>
      <organization>Boston Children's Hospital</organization>
      <phone>617-919-1222</phone>
      <email>Michele.DeGrazia@childrens.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01683812
org study id: IRB-P00003465
nct id: NCT01683812
lead sponsor: 
has dmc: Yes
The purpose of this descriptive study is to provide information on the feasibility of using
      the cranial cup, a new positioning device, in a small sample of prematurely born infants with
      elongated head shapes as a result of laying on their abdomens, during the convalescent phase
      of their hospitalizations.
The cranial cup is a non-invasive, non-restrictive, adjustable orthotic device that grows
      with the infant and maintains proper body alignment while promoting normal head shape
      development. While the cranial cup is not yet FDA approved, it is considered a
      non-significant medical device and it has successfully corrected asymmetric positional head
      shape deformities in hundreds of healthy newborns less than 4 months of age cared for by the
      Children's Hospital Boston outpatient plagiocephaly clinic. Additionally preliminary analysis
      of a prospective randomized controlled trial currently underway suggests that the cranial cup
      may be useful in prevention of positional head shape deformity in a cohort of hospitalized
      infants of varying gestational ages. However, the cranial cup has never been used for
      correction of the most common form of positional head shape deformity in hospitalized
      premature infants; namely dolichocephaly. Thus, the purpose of this descriptive study is to
      provide information on the feasibility of using the cranial cup in a small sample of
      prematurely born infants with dolichocephaly during the convalescent phase of their
      hospitalizations. Information obtained from this descriptive study will be used to determine
      if a larger investigation using the cranial cup is warranted in this specific patient
      population.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility and Safety
time frame: Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days
description: Nurses will complete daily logs indicating the number of desaturation events (oxygen saturation of < 90 percent for infant corrected to full term or < 87 percent for a premature infant for > 10 seconds) and emesis events (regurgitation of breast milk or formula) during cranial cup device use. The cup's designated use is for at least 12 hours per day. Study duration is at least 14 days and can continue until the infant is discharged. Comparisons will be made for the number of desaturation events and emesis during data analysis.
measure: Cranial Measurement Description
time frame: Using head measurements obtained at timepoint 1 enrollment (baseline, day 1) and at timepoint 2 discharge (14-120 days)
description: To describe infant head shape, the study will use cranial measurements and laser head scans in a sample of prematurely born Neonatal Intensive Care (NICU) or Special Care Nursery (SCN) patients with dolichocephaly. Cranial measurement used is cranial index, an objective measure that quantifies head shape by dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Measurements and scans will be taken directly following study enrollment and discharge to document head shape pre and post intervention. The discharge measure will be obtained at approximately 2 weeks-4 months of age at hospital discharge.
arm group label: Cranial Cup Arm
arm group type: Experimental
description: Single arm
intervention type: Device
intervention name: Cranial Cup
description: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.
arm group label: Cranial Cup Arm
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Year
healthy volunteers: No
last name: Michele DeGrazia, PhD
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: Aimee Knorr, MD
role: Principal Investigator
affiliation: Winchester Hospital
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Michele DeGrazia
investigator title: Director of Nursing Research NICU
mesh term: Congenital Abnormalities
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 