<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/NCT01666457</url>
  </required_header>
  <id_info>
    <org_study_id>2009-13949 Horner</org_study_id>
    <nct_id>NCT01666457</nct_id>
  </id_info>
  <brief_title>Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)</brief_title>
  <official_title>The Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the NICU</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ann &amp; Robert H Lurie Children's Hospital of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific aim of this pre-post trial is to compare data regarding oral feeding, length of&#xD;
      stay, and growth outcomes of 100 NICU infants to these same outcomes following the&#xD;
      implementation of a developmentally supportive, infant driven feeding program with the NICU&#xD;
      staff, specifically the Supporting Oral Feeding in Fragile Infants (SOFFI) infant feeding&#xD;
      program on a second sample of 100 NICU infants at Children's Memorial Hospital.&#xD;
&#xD;
      The specific research questions considered in this study are:&#xD;
&#xD;
        1. What is the impact of implementing the SOFFI on the oral feeding outcomes of medically&#xD;
           fragile infants in the NICU at discharge and at 3 months post-term?&#xD;
&#xD;
        2. What is the impact of implementing the SOFFI on the growth outcomes of medically fragile&#xD;
           infants in the NICU at discharge and at 3 months post-term?&#xD;
&#xD;
        3. What is the impact of implementing the SOFFI on the length of stay of medically fragile&#xD;
           infants in the NICU?&#xD;
&#xD;
        4. What is the impact of implementing the SOFFI on the clarity and consistency of NICU&#xD;
           staff evaluations and communications related to managing oral feedings with medically&#xD;
           fragile infants?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oral feeding outcomes</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Defined as percentage of ordered full feeding volume as ordered by NICU staff taken orally at NICU discharge and, if applicable, the number of days to take 100% of ordered feeding volume orally.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Feeding Outcomes</measure>
    <time_frame>Up to 5 months</time_frame>
    <description>Infant oral feeding outcomes per structured parent phone interview at home.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Growth outcomes</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Defined as an infant's height, weight and length percentiles on the Center for Disease Control (CDC) growth chart at NICU discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth Outcomes</measure>
    <time_frame>Up to 5 months</time_frame>
    <description>Growth outcomes per parent report during phone interview at home include current weight to be reported as percentile on CDC growth chart.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Length of Stay</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Length of stay in days in the NICU</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in NICU staff evaluations and communications r/t infants' oral feeding pre-SOFFI to post-SOFFI</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Measured by staff surveys done prior to and at least 3 months following SOFFI training with NICU staff. Two surveys include one for Registered Nurses (RNs)and second survey for MD/Advanced Practice Nursing (APN) staff.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">156</enrollment>
  <condition>Oral Feeding Outcomes</condition>
  <condition>Growth</condition>
  <condition>Length of NICU Stay</condition>
  <arm_group>
    <arm_group_label>Pre-SOFFI infants</arm_group_label>
    <description>Infants discharged from the NICU prior to the implementation of the SOFFI infant driven feeding program with NICU staff.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post SOFFI infants</arm_group_label>
    <description>Subject infants discharged from the NICU at least 6 months after the implementation of the SOFFI infant driven feeding program and</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SOFFI</intervention_name>
    <description>NICU nursing and multidisciplinary staff were trained to use the SOFFI infant driven feeding program. A small group of learners (20) were trained as resources via a 2-day course and the entire nursing staff received training during a 1-1.5 hour training lecture during their annual competencies.</description>
    <arm_group_label>Post SOFFI infants</arm_group_label>
    <other_name>Supporting Oral Feedings in Fragile Infants</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Convenience sample of NICU infants discharged home prior to the implementation of the SOFFI&#xD;
        will be compared to a convenience sample of NICU infants discharged home following the&#xD;
        implementation of the SOFFI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants of all gestations and diagnostic groups in this tertiary level NICU will be&#xD;
             included in the sample&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with medical diagnoses known to impact sucking and swallowing&#xD;
&#xD;
          -  Infants unable to manage their oral secretions&#xD;
&#xD;
          -  Infants who remain hospitalized beyond 3 months adjusted age&#xD;
&#xD;
               -  Infants who expire or are transferred to another inpatient unit or&#xD;
                  hospital/facility prior to discharge from the NICU&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>5 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan M Horner, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ann &amp; Robert H Lurie Children's Hospital of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ann &amp; Robert H Lurie Childrens Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>August 16, 2018</last_update_submitted>
  <last_update_submitted_qc>August 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ann &amp; Robert H Lurie Children's Hospital of Chicago</investigator_affiliation>
    <investigator_full_name>Susan M Horner, MS, APN/CNS, RNC-NIC</investigator_full_name>
    <investigator_title>Developmental Specialist</investigator_title>
  </responsible_party>
  <keyword>Supporting Oral Feeding in Fragile Infants (SOFFI)</keyword>
  <keyword>Infant Oral Feeding</keyword>
  <keyword>Infant Growth</keyword>
  <keyword>Preterm infant oral feeding</keyword>
  <keyword>Preterm infant growth</keyword>
  <keyword>Neonatal Intensive Care Unit (NICU)</keyword>
  <!-- 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/NCT01666457
org study id: 2009-13949 Horner
nct id: NCT01666457
lead sponsor: 
has dmc: No
The specific aim of this pre-post trial is to compare data regarding oral feeding, length of
      stay, and growth outcomes of 100 NICU infants to these same outcomes following the
      implementation of a developmentally supportive, infant driven feeding program with the NICU
      staff, specifically the Supporting Oral Feeding in Fragile Infants (SOFFI) infant feeding
      program on a second sample of 100 NICU infants at Children's Memorial Hospital.

      The specific research questions considered in this study are:

        1. What is the impact of implementing the SOFFI on the oral feeding outcomes of medically
           fragile infants in the NICU at discharge and at 3 months post-term?

        2. What is the impact of implementing the SOFFI on the growth outcomes of medically fragile
           infants in the NICU at discharge and at 3 months post-term?

        3. What is the impact of implementing the SOFFI on the length of stay of medically fragile
           infants in the NICU?

        4. What is the impact of implementing the SOFFI on the clarity and consistency of NICU
           staff evaluations and communications related to managing oral feedings with medically
           fragile infants?
observational model: Other
time perspective: Prospective
measure: Oral feeding outcomes
time frame: Up to 3 months
description: Defined as percentage of ordered full feeding volume as ordered by NICU staff taken orally at NICU discharge and, if applicable, the number of days to take 100% of ordered feeding volume orally.
measure: Oral Feeding Outcomes
time frame: Up to 5 months
description: Infant oral feeding outcomes per structured parent phone interview at home.
measure: Growth outcomes
time frame: Up to 3 months
description: Defined as an infant's height, weight and length percentiles on the Center for Disease Control (CDC) growth chart at NICU discharge
measure: Growth Outcomes
time frame: Up to 5 months
description: Growth outcomes per parent report during phone interview at home include current weight to be reported as percentile on CDC growth chart.
measure: Length of Stay
time frame: Up to 3 months
description: Length of stay in days in the NICU
measure: Change in NICU staff evaluations and communications r/t infants' oral feeding pre-SOFFI to post-SOFFI
time frame: Up to 2 years
description: Measured by staff surveys done prior to and at least 3 months following SOFFI training with NICU staff. Two surveys include one for Registered Nurses (RNs)and second survey for MD/Advanced Practice Nursing (APN) staff.
arm group label: Pre-SOFFI infants
description: Infants discharged from the NICU prior to the implementation of the SOFFI infant driven feeding program with NICU staff.
arm group label: Post SOFFI infants
description: Subject infants discharged from the NICU at least 6 months after the implementation of the SOFFI infant driven feeding program and
intervention type: Other
intervention name: SOFFI
description: NICU nursing and multidisciplinary staff were trained to use the SOFFI infant driven feeding program. A small group of learners (20) were trained as resources via a 2-day course and the entire nursing staff received training during a 1-1.5 hour training lecture during their annual competencies.
arm group label: Post SOFFI infants
other name: Supporting Oral Feedings in Fragile Infants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Months
maximum age: 5 Months
healthy volunteers: No
last name: Susan M Horner, MS
role: Principal Investigator
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
investigator full name: Susan M Horner, MS, APN/CNS, RNC-NIC
investigator title: Developmental Specialist