<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/NCT03246243</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00023193</org_study_id>
    <nct_id>NCT03246243</nct_id>
  </id_info>
  <brief_title>Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk</brief_title>
  <official_title>Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Winchester Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main goal of this study is to quantitatively assess the sucking and feeding activity of&#xD;
      infants at high risk of neurological impairment (preterm infants and term infants at risk of&#xD;
      abnormal neurodevelopment) during oral sucking and feeding and correlate it with their&#xD;
      underlying neurological impairment for the early diagnosis of brain injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research will address the current lack of objective tools for the reliable assessment of&#xD;
      oral sucking and feeding in clinical practice, and the insufficient evidence that relates&#xD;
      early measures of abnormal sucking activity with the underlying neurological impairment.&#xD;
&#xD;
      The main goal of this study is to quantitatively assess the sucking and feeding activity of&#xD;
      infants at high risk of neurological impairment (preterm infants and term infants at risk of&#xD;
      abnormal neurodevelopment) during oral sucking and feeding and correlate it with their&#xD;
      underlying neurological impairment for the early diagnosis of brain injury. We aim to study&#xD;
      three groups of infants who are inpatients on the Neonatal Intensive Care Unit (NICU) at&#xD;
      Boston Children's Hospital (BCH), the NICU or Newborn Nursery at Beth Israel Deaconess&#xD;
      Medical Center (BIDMC), the Special Care Nursery (SCN) or Newborn Nursery at Winchester&#xD;
      Hospital as follows: (i) group A consisting of preterm infants (gestational age of &lt;37&#xD;
      weeks), (ii) group B consisting of term infants admitted to the NICU at BCH and BIDMC for&#xD;
      therapeutic hypothermia who are at risk of developing hypoxic ischemic injury (HIE); admitted&#xD;
      with concern for neonatal stroke; seizures of unknown etiology; and those admitted to the&#xD;
      NICU, SCN or Newborn Nursery at BCH, BIDMC and Winchester Hospital at risk of abnormal&#xD;
      neurodevelopment such as those with hypoglycemia or neonatal abstinence syndrome (NAS) and;&#xD;
      (iii) group C consisting of healthy term infants admitted to the NICU, SCN or nursery who had&#xD;
      an initial uncomplicated postnatal course that will serve as the control group. Additionally,&#xD;
      those infants who have MRI of the brain for any reason during the course of their hospital&#xD;
      admission will also be included in the study and allocated to the appropriate group&#xD;
      accordingly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulties in recruitment.&#xD;
  </why_stopped>
  <start_date type="Actual">March 29, 2017</start_date>
  <completion_date type="Actual">May 18, 2021</completion_date>
  <primary_completion_date type="Actual">May 18, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in sucking activity of infants with brain injury</measure>
    <time_frame>Approximately one year through study completion</time_frame>
    <description>Primary outcome will be an assessment of the sucking activity of infants with brain injury and infants without brain injury, using an FDA-approved device for sucking assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sucking activity of infants and brain connectivity</measure>
    <time_frame>Approximately three years through study completion</time_frame>
    <description>The functional and structural connectivity of the brain areas involved in sucking and feeding in infants with brain injury will be assessed reviewing the results of clinically ordered neuroimaging and neurodevelopmental tests.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Hypoxic-Ischemic Encephalopathy</condition>
  <condition>Hypoglycemia</condition>
  <condition>Neonatal Abstinence Syndrome</condition>
  <arm_group>
    <arm_group_label>Preterm infants</arm_group_label>
    <description>Group A will consist of preterm infants born &lt; 37 weeks gestational age. Non-nutritive and nutritive sucking will be assessed using an FDA-approved device (Nfant Feeding Solution) to measure sucking activity. Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly. If a subject undergoes any clinically ordered EEG, EMG, MEG, and MRI throughout the duration of their study participation before the age of three then that data will be collected from their medical record. Additionally, any neurodevelopmental testing data completed up to the age of three will be collected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Term infants with HIE or at risk of brain injury</arm_group_label>
    <description>Group B will consist of term infants admitted to the NICU for therapeutic hypothermia who are at risk of HIE; admitted with concern for neonatal stroke; seizures of unknown etiology; and those admitted who are at risk of abnormal neurodevelopment such as those with hypoglycemia or NAS. Non-nutritive and nutritive sucking will be assessed using an FDA-approved device (Nfant Feeding Solution) to measure sucking activity. Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly. If a subject undergoes any clinically ordered EEG, EMG, MEG, and MRI throughout the duration of their study participation before the age of three then that data will be collected from their medical record. Additionally, any neurodevelopmental testing data completed up to the age of three will be collected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Term infants healthy at birth</arm_group_label>
    <description>Group C will consist of healthy term infants from the community and term infants admitted to who had an initial uncomplicated postnatal course that will serve as the control group. Non-nutritive and nutritive sucking will be assessed using an FDA-approved device (Nfant Feeding Solution) to measure sucking activity. Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly. If a subject undergoes any clinically ordered EEG, EMG, MEG, and MRI throughout the duration of their study participation before the age of three then that data will be collected from their medical record. Additionally, any neurodevelopmental testing data completed up to the age of three will be collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>nfant feeding solution</intervention_name>
    <description>The study will record the sucking activity of the hospitalized infants over time, from their first oral sucking session including non-nutritive and nutritive sucking, until discharge, using an FDA-approved device that equips a typical bottle and nipple commonly used in the NICU with a non-invasive sensor to measure sucking activity. Each infant's nutritive and non-nutritive sucking patterns will be measured, and will comprise the 'sucking session' conducted with the bottle sensor.</description>
    <arm_group_label>Preterm infants</arm_group_label>
    <arm_group_label>Term infants healthy at birth</arm_group_label>
    <arm_group_label>Term infants with HIE or at risk of brain injury</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Preterm infants at risk of brain injury; Term infants at risk of brain injury; and Healthy&#xD;
        term infants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preterm infants with GA&lt;37 weeks&#xD;
&#xD;
          -  Term infants with GA&gt;37 weeks and at risk of brain injury&#xD;
&#xD;
          -  Healthy term infants with GA= 37-41 weeks, appropriate birth weight, 5 minute Apgar&#xD;
             score&gt;7, and an initial uncomplicated postnatal course&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  major congenital anomalies&#xD;
&#xD;
          -  craniofacial malformation&#xD;
&#xD;
          -  short bowel syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christos Papadelis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's 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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>May 19, 2021</last_update_submitted>
  <last_update_submitted_qc>May 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Christos Papadelis</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Hypoxic Ischemic Encephalopathy</keyword>
  <keyword>Bottle Feeding</keyword>
  <keyword>Hypoglycemia</keyword>
  <keyword>Neonatal Abstinence Syndrome</keyword>
  <keyword>Abnormal Neurodevelopment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Hypoxia-Ischemia, Brain</mesh_term>
    <mesh_term>Neonatal Abstinence Syndrome</mesh_term>
    <mesh_term>Hypoglycemia</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/NCT03246243
org study id: IRB-P00023193
nct id: NCT03246243
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The main goal of this study is to quantitatively assess the sucking and feeding activity of
      infants at high risk of neurological impairment (preterm infants and term infants at risk of
      abnormal neurodevelopment) during oral sucking and feeding and correlate it with their
      underlying neurological impairment for the early diagnosis of brain injury.
This research will address the current lack of objective tools for the reliable assessment of
      oral sucking and feeding in clinical practice, and the insufficient evidence that relates
      early measures of abnormal sucking activity with the underlying neurological impairment.

      The main goal of this study is to quantitatively assess the sucking and feeding activity of
      infants at high risk of neurological impairment (preterm infants and term infants at risk of
      abnormal neurodevelopment) during oral sucking and feeding and correlate it with their
      underlying neurological impairment for the early diagnosis of brain injury. We aim to study
      three groups of infants who are inpatients on the Neonatal Intensive Care Unit (NICU) at
      Boston Children's Hospital (BCH), the NICU or Newborn Nursery at Beth Israel Deaconess
      Medical Center (BIDMC), the Special Care Nursery (SCN) or Newborn Nursery at Winchester
      Hospital as follows: (i) group A consisting of preterm infants (gestational age of <37
      weeks), (ii) group B consisting of term infants admitted to the NICU at BCH and BIDMC for
      therapeutic hypothermia who are at risk of developing hypoxic ischemic injury (HIE); admitted
      with concern for neonatal stroke; seizures of unknown etiology; and those admitted to the
      NICU, SCN or Newborn Nursery at BCH, BIDMC and Winchester Hospital at risk of abnormal
      neurodevelopment such as those with hypoglycemia or neonatal abstinence syndrome (NAS) and;
      (iii) group C consisting of healthy term infants admitted to the NICU, SCN or nursery who had
      an initial uncomplicated postnatal course that will serve as the control group. Additionally,
      those infants who have MRI of the brain for any reason during the course of their hospital
      admission will also be included in the study and allocated to the appropriate group
      accordingly.
observational model: Cohort
time perspective: Prospective
measure: Difference in sucking activity of infants with brain injury
time frame: Approximately one year through study completion
description: Primary outcome will be an assessment of the sucking activity of infants with brain injury and infants without brain injury, using an FDA-approved device for sucking assessment.
measure: Sucking activity of infants and brain connectivity
time frame: Approximately three years through study completion
description: The functional and structural connectivity of the brain areas involved in sucking and feeding in infants with brain injury will be assessed reviewing the results of clinically ordered neuroimaging and neurodevelopmental tests.
arm group label: Preterm infants
description: Group A will consist of preterm infants born < 37 weeks gestational age. Non-nutritive and nutritive sucking will be assessed using an FDA-approved device (Nfant Feeding Solution) to measure sucking activity. Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly. If a subject undergoes any clinically ordered EEG, EMG, MEG, and MRI throughout the duration of their study participation before the age of three then that data will be collected from their medical record. Additionally, any neurodevelopmental testing data completed up to the age of three will be collected.
arm group label: Term infants with HIE or at risk of brain injury
description: Group B will consist of term infants admitted to the NICU for therapeutic hypothermia who are at risk of HIE; admitted with concern for neonatal stroke; seizures of unknown etiology; and those admitted who are at risk of abnormal neurodevelopment such as those with hypoglycemia or NAS. Non-nutritive and nutritive sucking will be assessed using an FDA-approved device (Nfant Feeding Solution) to measure sucking activity. Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly. If a subject undergoes any clinically ordered EEG, EMG, MEG, and MRI throughout the duration of their study participation before the age of three then that data will be collected from their medical record. Additionally, any neurodevelopmental testing data completed up to the age of three will be collected.
arm group label: Term infants healthy at birth
description: Group C will consist of healthy term infants from the community and term infants admitted to who had an initial uncomplicated postnatal course that will serve as the control group. Non-nutritive and nutritive sucking will be assessed using an FDA-approved device (Nfant Feeding Solution) to measure sucking activity. Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly. If a subject undergoes any clinically ordered EEG, EMG, MEG, and MRI throughout the duration of their study participation before the age of three then that data will be collected from their medical record. Additionally, any neurodevelopmental testing data completed up to the age of three will be collected.
intervention type: Device
intervention name: nfant feeding solution
description: The study will record the sucking activity of the hospitalized infants over time, from their first oral sucking session including non-nutritive and nutritive sucking, until discharge, using an FDA-approved device that equips a typical bottle and nipple commonly used in the NICU with a non-invasive sensor to measure sucking activity. Each infant's nutritive and non-nutritive sucking patterns will be measured, and will comprise the 'sucking session' conducted with the bottle sensor.
arm group label: Preterm infants
arm group label: Term infants healthy at birth
arm group label: Term infants with HIE or at risk of brain injury
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Christos Papadelis, PhD
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Christos Papadelis
investigator title: PhD
mesh term: Brain Injuries
mesh term: Brain Diseases
mesh term: Brain Ischemia
mesh term: Hypoxia-Ischemia, Brain
mesh term: Neonatal Abstinence Syndrome
mesh term: Hypoglycemia
sharing ipd: No