<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/NCT04419857</url>
  </required_header>
  <id_info>
    <org_study_id>2000028252</org_study_id>
    <secondary_id>2T35DK104689-06</secondary_id>
    <nct_id>NCT04419857</nct_id>
  </id_info>
  <brief_title>A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants</brief_title>
  <official_title>A Randomized Control Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</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>
      A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach&#xD;
      comparing early weight loss on a standard-caloric density versus high-caloric density feeding&#xD;
      regimen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aims of the study is to systematically evaluate the benefit of high-caloric diet regimens&#xD;
      given to NAS infants in the first three weeks of life. Breastfeeding is the preferred feeding&#xD;
      method for NAS infants as it has shown to reduce NAS severity and infant weight loss, though&#xD;
      women who are not adherent to drug treatment programs or have the potential to use illicit&#xD;
      drugs are not able to breastfeed due to the risks posed to the infant. Several studies have&#xD;
      demonstrated the potential for caloric enhancement of formula and breast milk to support&#xD;
      weight gain in NAS infants. Through a randomized control trial analyzing infant weight gain&#xD;
      on standard-calorie vs. high-calorie diet regimens, we aim to quantify weight patterns in NAS&#xD;
      infants and show that increasing caloric intake can improve weight gain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 4, 2020</start_date>
  <completion_date type="Anticipated">May 2026</completion_date>
  <primary_completion_date type="Anticipated">May 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal percent weight loss compared to birth weight</measure>
    <time_frame>2 weeks</time_frame>
    <description>this will be measured by twice daily weights while in the hospital and once daily weights at home for two weeks after birth compared with birth weight</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hours to weight nadir</measure>
    <time_frame>2 weeks</time_frame>
    <description>Measured by determining the hours of life that the maximal percent weight loss was obtained for each patient, assessed within the first two weeks after birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to return to birthweight</measure>
    <time_frame>1 month</time_frame>
    <description>Measured by determining the days of life each patient regained birthweight, assessed within the first month after birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent weight change per day</measure>
    <time_frame>2 weeks</time_frame>
    <description>Measured by comparing the weight from the weight obtained the day prior, assessed daily for the first two weeks after birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>up to 6.5 days</time_frame>
    <description>Measured by comparing admission time to discharge time, assessed at hospital discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Neonatal Abstinence Syndrome</condition>
  <arm_group>
    <arm_group_label>High-calorie formula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infant randomly assigned to high-calorie formula for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard calorie formula</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Infant randomly assigned to standard-calorie formula for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High-calorie formula</intervention_name>
    <description>Infant randomly assigned to high-calorie formula for 14 days</description>
    <arm_group_label>High-calorie formula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Infant Inclusion Criteria:&#xD;
&#xD;
          -  Infants with NAS born to mothers age 18-45 with methadone exposure before or during&#xD;
             pregnancy who do not intend to place their infants for adoption&#xD;
&#xD;
          -  Infants &gt; 2200 g Infants at least 36 weeks gestational age&#xD;
&#xD;
          -  Delivered at: Yale New Haven Hospital&#xD;
&#xD;
          -  Mothers/infants able to return to outpatient pediatric provider for 2 month and 4&#xD;
             month weights visits&#xD;
&#xD;
        Infant Exclusion Criteria:&#xD;
&#xD;
          -  Infants with major congenital malformations&#xD;
&#xD;
          -  Infants enrolled to NICU &gt;24 hours for medical conditions other than NAS treatment&#xD;
             before 3 days of life&#xD;
&#xD;
        Mother's Inclusion criteria -&#xD;
&#xD;
          -  Pregnant women (age 18-45) who have started methadone treatment at obstetrics or other&#xD;
             YNHH appointments&#xD;
&#xD;
          -  Confirm methadone treatment is received from a licensed treatment program&#xD;
&#xD;
          -  Confirm that mothers are planning to deliver their infant(s) at Yale New Haven&#xD;
             Hospital&#xD;
&#xD;
          -  Confirm that mothers do not intend to place the infant(s) for adoption&#xD;
&#xD;
          -  Confirm mother's willingness to participate in the study (including attending the&#xD;
             2-month and 4-month follow up weigh-ins with pediatrician)&#xD;
&#xD;
          -  Consent forms will be signed and faxed to study staff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Grossman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lisa Palmieri, BA</last_name>
    <phone>203-785-4651</phone>
    <email>lisa.palmieri@yale.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06512</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Grossman, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Francis Cheng, MD</last_name>
      <email>frances.cheng@yale.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Matthew Grossman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>high-caloric diet regimens</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neonatal Abstinence Syndrome</mesh_term>
    <mesh_term>Weight Gain</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/NCT04419857
org study id: 2000028252
secondary id: 2T35DK104689-06
nct id: NCT04419857
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach
      comparing early weight loss on a standard-caloric density versus high-caloric density feeding
      regimen.
The aims of the study is to systematically evaluate the benefit of high-caloric diet regimens
      given to NAS infants in the first three weeks of life. Breastfeeding is the preferred feeding
      method for NAS infants as it has shown to reduce NAS severity and infant weight loss, though
      women who are not adherent to drug treatment programs or have the potential to use illicit
      drugs are not able to breastfeed due to the risks posed to the infant. Several studies have
      demonstrated the potential for caloric enhancement of formula and breast milk to support
      weight gain in NAS infants. Through a randomized control trial analyzing infant weight gain
      on standard-calorie vs. high-calorie diet regimens, we aim to quantify weight patterns in NAS
      infants and show that increasing caloric intake can improve weight gain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Maximal percent weight loss compared to birth weight
time frame: 2 weeks
description: this will be measured by twice daily weights while in the hospital and once daily weights at home for two weeks after birth compared with birth weight
measure: Hours to weight nadir
time frame: 2 weeks
description: Measured by determining the hours of life that the maximal percent weight loss was obtained for each patient, assessed within the first two weeks after birth
measure: Days to return to birthweight
time frame: 1 month
description: Measured by determining the days of life each patient regained birthweight, assessed within the first month after birth
measure: Percent weight change per day
time frame: 2 weeks
description: Measured by comparing the weight from the weight obtained the day prior, assessed daily for the first two weeks after birth
measure: Length of hospital stay
time frame: up to 6.5 days
description: Measured by comparing admission time to discharge time, assessed at hospital discharge
arm group label: High-calorie formula
arm group type: Experimental
description: Infant randomly assigned to high-calorie formula for 14 days
arm group label: Standard calorie formula
arm group type: No Intervention
description: Infant randomly assigned to standard-calorie formula for 14 days
intervention type: Dietary Supplement
intervention name: High-calorie formula
description: Infant randomly assigned to high-calorie formula for 14 days
arm group label: High-calorie formula
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Matthew Grossman, MD
role: Principal Investigator
affiliation: Yale University
last name: Lisa Palmieri, BA
phone: 203-785-4651
email: lisa.palmieri@yale.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Neonatal Abstinence Syndrome
mesh term: Weight Gain
sharing ipd: No