<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/NCT04421482</url>
  </required_header>
  <id_info>
    <org_study_id>20-00876</org_study_id>
    <nct_id>NCT04421482</nct_id>
  </id_info>
  <brief_title>Cold Milk for Dysphagia in Preterm Infants</brief_title>
  <official_title>Cold Milk as a Novel Therapy for Dysphagia in Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</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>
      It is estimated that 30-70% of very low birth weight (VLBW) preterm infants will be diagnosed&#xD;
      with swallowing dysfunction (dysphagia), which often leads to airway compromise in the form&#xD;
      of laryngeal penetration and/or tracheal aspiration during oral feeding attempts. Chronic&#xD;
      airway compromise results in a persistent inflammatory state, with disease progression that&#xD;
      can be devastating for already fragile and developmentally immature lungs in preterm infants.&#xD;
      At this time, there are limited therapeutic options for dysphagia in VLBW infants during oral&#xD;
      feeding. In a recent publication, our research group was the first to demonstrate that&#xD;
      short-duration of oral feeding with cold liquid reduces dysphagia occurrence from 71% to 26%.&#xD;
      However, these data must be further validated for the effectiveness and safety of a full&#xD;
      duration feeding before being recommended for routine clinical practice.&#xD;
&#xD;
      The objective is to identify preliminary evidence for the efficacy and safety of feeding full&#xD;
      oral cold milk for dysphagia management in preterm infants. We hypothesize that oral feeding&#xD;
      of cold milk in VLBW preterm infants with dysphagia will improve suck/swallow/breathe&#xD;
      coordination and decrease penetration/ aspiration to the airway. We further hypothesize that&#xD;
      cold milk intervention will have no adverse effects on intestinal blood flow, as assessed by&#xD;
      Doppler Ultrasound. This is significant because there is a critical need to identify&#xD;
      effective and safe evidence-based treatment options for dysphagia management in preterm&#xD;
      infants.&#xD;
&#xD;
      This prospective study will seek to enroll Subjects who meet the following inclusion&#xD;
      criteria: 1) VLBW (birth weight less than 1,500g and less than 32 weeks gestation), 2)&#xD;
      admitted to NYU-Winthrop NICU, 3) Post-menstrual age (PMA) &gt; 35 weeks at the time of the&#xD;
      study, 4) receiving no or minimum respiratory support (&lt;1 lit/min low-flow nasal cannula), 5)&#xD;
      tolerating at least 50% of their enteral feeding orally, 6) having symptoms of swallowing&#xD;
      dysfunction during oral feeding (clinical dysphagia) and 7) referred by the medical team for&#xD;
      video fluoroscopic swallow study (VFSS) and/or fiberoptic endoscopic evaluation of swallowing&#xD;
      (FEES).&#xD;
&#xD;
      To assess the efficacy of cold milk in treating dysphagia, study subjects will first have an&#xD;
      oral motor feeding assessment using an FDA approved device called the nFant® Feeding Solution&#xD;
      as well as VFSS and/or FEES. To assess the safety of using cold milk, subjects will receive a&#xD;
      doppler ultrasound before and after the ingestion of cold liquid feeding to assess the&#xD;
      mesenteric blood flow.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 4, 2021</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2024</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>
    <intervention_model_description>This will be a prospective study, with each infant serving as their own control. The order of each condition will be randomized to control for fatigue</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Suck/swallow/breathe coordination</measure>
    <time_frame>24 hours</time_frame>
    <description>Measured by a non-invasive FDA approved equipment (nFant® Feeding Solution) during each of the two 15-20 minute feedings feediing conditions (RTS and CS, which will be done within the same day).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intestinal blood flow</measure>
    <time_frame>24 hours</time_frame>
    <description>Intestinal blood flow monitoring via Doppler ultrasound (Sonosite Edge Ultrasound system, Sonosite, Inc, WA) will be performed 6 times for each participant, performed one hour before and at 30 and 60 minutes after both bedside feeding conditions (RTS and CS, which will be done within the same day).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Dysphagia of Newborn</condition>
  <arm_group>
    <arm_group_label>Very Low Birth Weight Preterm Infants</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Very Low Birth Weight Preterm Infants (birth weight less than 1,500g and less than 32 weeks gestation) admitted to NYU Winthrop NICU. (n=42)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard room temperature (RTS) feeding of milk/formula</intervention_name>
    <description>Evaluate the infant's sucking, swallowing, and breathing patterns using a non-invasive FDA approved equipment (nFant® Feeding Solution) under two separate feeding conditions: standard room temperature (RTS) and cold temperature (CS, at 4-9°C) of milk/formula for an entire feeding (15-20 minutes). The two feedings will be done on the same day but may not necessarily be two consecutive feedings (depending on the baby's eagerness to feed orally). The order of each condition will be randomized to control for fatigue.</description>
    <arm_group_label>Very Low Birth Weight Preterm Infants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cold temperature (CS, at 4-9°C) of milk/formula</intervention_name>
    <description>Evaluate the infant's sucking, swallowing, and breathing patterns using a non-invasive FDA approved equipment (nFant® Feeding Solution) under two separate feeding conditions, standard room temperature (RTS) and cold temperature (CS, at 4-9°C) of milk/formula for an entire feeding (15-20 minutes). The two feedings will be done on the same day but may not necessarily be two consecutive feedings (depending on the baby's eagerness to feed orally). The order of each condition will be randomized to control for fatigue.</description>
    <arm_group_label>Very Low Birth Weight Preterm Infants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. VLBW (birth weight less than 1,500g and less than 32 weeks gestation)&#xD;
&#xD;
          2. admitted to NYU-Winthrop NICU&#xD;
&#xD;
          3. PMA &gt; 35 weeks at the time of the study&#xD;
&#xD;
          4. receiving no or minimum respiratory support (&lt;1 lit/min low-flow nasal cannula)&#xD;
&#xD;
          5. tolerating at least 50% of their enteral feeding orally and&#xD;
&#xD;
          6. having symptoms of swallowing dysfunction during oral feeding (clinical dysphagia).&#xD;
&#xD;
          7. referred by the medical team for VFSS and/or FEES assessments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Infants with other comorbidities, such as IUGR, upper airway anomalies, brain injury,&#xD;
        neuromuscular disease, or life-threatening congenital disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Weeks</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nazeeh Hanna</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nazeeh Hanna, MD</last_name>
    <phone>516-663-3853</phone>
    <email>Nazeeh.hanna@NYULangone.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nazeeh Hanna, MD</last_name>
    </contact>
    <investigator>
      <last_name>Louisa Ferrara, PhD, CCC-SLP, BCS-S, CNT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ranjith Kamity, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vikramaditya Dumpa, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Nazeeh.hanna@NYULangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
    <ipd_access_criteria>Researchers who provide a methodologically sound proposal may direct requests to Nazeeh.hanna@NYULangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </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/NCT04421482
org study id: 20-00876
nct id: NCT04421482
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It is estimated that 30-70% of very low birth weight (VLBW) preterm infants will be diagnosed
      with swallowing dysfunction (dysphagia), which often leads to airway compromise in the form
      of laryngeal penetration and/or tracheal aspiration during oral feeding attempts. Chronic
      airway compromise results in a persistent inflammatory state, with disease progression that
      can be devastating for already fragile and developmentally immature lungs in preterm infants.
      At this time, there are limited therapeutic options for dysphagia in VLBW infants during oral
      feeding. In a recent publication, our research group was the first to demonstrate that
      short-duration of oral feeding with cold liquid reduces dysphagia occurrence from 71% to 26%.
      However, these data must be further validated for the effectiveness and safety of a full
      duration feeding before being recommended for routine clinical practice.

      The objective is to identify preliminary evidence for the efficacy and safety of feeding full
      oral cold milk for dysphagia management in preterm infants. We hypothesize that oral feeding
      of cold milk in VLBW preterm infants with dysphagia will improve suck/swallow/breathe
      coordination and decrease penetration/ aspiration to the airway. We further hypothesize that
      cold milk intervention will have no adverse effects on intestinal blood flow, as assessed by
      Doppler Ultrasound. This is significant because there is a critical need to identify
      effective and safe evidence-based treatment options for dysphagia management in preterm
      infants.

      This prospective study will seek to enroll Subjects who meet the following inclusion
      criteria: 1) VLBW (birth weight less than 1,500g and less than 32 weeks gestation), 2)
      admitted to NYU-Winthrop NICU, 3) Post-menstrual age (PMA) > 35 weeks at the time of the
      study, 4) receiving no or minimum respiratory support (<1 lit/min low-flow nasal cannula), 5)
      tolerating at least 50% of their enteral feeding orally, 6) having symptoms of swallowing
      dysfunction during oral feeding (clinical dysphagia) and 7) referred by the medical team for
      video fluoroscopic swallow study (VFSS) and/or fiberoptic endoscopic evaluation of swallowing
      (FEES).

      To assess the efficacy of cold milk in treating dysphagia, study subjects will first have an
      oral motor feeding assessment using an FDA approved device called the nFant® Feeding Solution
      as well as VFSS and/or FEES. To assess the safety of using cold milk, subjects will receive a
      doppler ultrasound before and after the ingestion of cold liquid feeding to assess the
      mesenteric blood flow.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This will be a prospective study, with each infant serving as their own control. The order of each condition will be randomized to control for fatigue
primary purpose: Treatment
masking: None (Open Label)
measure: Suck/swallow/breathe coordination
time frame: 24 hours
description: Measured by a non-invasive FDA approved equipment (nFant® Feeding Solution) during each of the two 15-20 minute feedings feediing conditions (RTS and CS, which will be done within the same day).
measure: Intestinal blood flow
time frame: 24 hours
description: Intestinal blood flow monitoring via Doppler ultrasound (Sonosite Edge Ultrasound system, Sonosite, Inc, WA) will be performed 6 times for each participant, performed one hour before and at 30 and 60 minutes after both bedside feeding conditions (RTS and CS, which will be done within the same day).
arm group label: Very Low Birth Weight Preterm Infants
arm group type: Other
description: Very Low Birth Weight Preterm Infants (birth weight less than 1,500g and less than 32 weeks gestation) admitted to NYU Winthrop NICU. (n=42)
intervention type: Other
intervention name: Standard room temperature (RTS) feeding of milk/formula
description: Evaluate the infant's sucking, swallowing, and breathing patterns using a non-invasive FDA approved equipment (nFant® Feeding Solution) under two separate feeding conditions: standard room temperature (RTS) and cold temperature (CS, at 4-9°C) of milk/formula for an entire feeding (15-20 minutes). The two feedings will be done on the same day but may not necessarily be two consecutive feedings (depending on the baby's eagerness to feed orally). The order of each condition will be randomized to control for fatigue.
arm group label: Very Low Birth Weight Preterm Infants
intervention type: Other
intervention name: Cold temperature (CS, at 4-9°C) of milk/formula
description: Evaluate the infant's sucking, swallowing, and breathing patterns using a non-invasive FDA approved equipment (nFant® Feeding Solution) under two separate feeding conditions, standard room temperature (RTS) and cold temperature (CS, at 4-9°C) of milk/formula for an entire feeding (15-20 minutes). The two feedings will be done on the same day but may not necessarily be two consecutive feedings (depending on the baby's eagerness to feed orally). The order of each condition will be randomized to control for fatigue.
arm group label: Very Low Birth Weight Preterm Infants
criteria: 
gender: All
minimum age: 35 Weeks
maximum age: N/A
healthy volunteers: No
last name: Nazeeh Hanna
role: Principal Investigator
affiliation: NYU Langone Health
last name: Nazeeh Hanna, MD
phone: 516-663-3853
email: Nazeeh.hanna@NYULangone.org
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Deglutition Disorders
sharing ipd: Yes
ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Nazeeh.hanna@NYULangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
ipd access criteria: Researchers who provide a methodologically sound proposal may direct requests to Nazeeh.hanna@NYULangone.org. To gain access, data requestors will need to sign a data access agreement.