<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/NCT03267043</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR4899</org_study_id>
    <nct_id>NCT03267043</nct_id>
  </id_info>
  <brief_title>Family Nurture Intervention in the NICU at The Valley Hospital</brief_title>
  <official_title>Family Nurture Intervention in the NICU at The Valley Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia 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>
      The purpose of this study is to compare neurodevelopment and activity in infants born preterm&#xD;
      (25 to 34 1/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture&#xD;
      Intervention (FNI) in the neonatal intensive care unit (NICU).&#xD;
&#xD;
      The investigators hypothesize that FNI will improve: i) neonatal electroencephalographic&#xD;
      activity ii) maternal caregiving and wellbeing (psychological and physiological, and iii)&#xD;
      infant behavior and neurodevelopment at 18 months corrected age (CA).&#xD;
&#xD;
      The two-phase effectiveness study aims to:&#xD;
&#xD;
        -  Phase 1 - Examine the existing Standard Care Approximately 35 infants and their mothers&#xD;
&#xD;
        -  Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby&#xD;
           receives the intervention Approximately 35 infants and their mothers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to build upon the findings of the earlier randomized controlled trial (RCT)&#xD;
      conducted at the Columbia University Medical Center (CUMC) comparing effects, both&#xD;
      physiological and emotional, of the current standard method of encouraging contact between&#xD;
      mothers and their babies in the NICU with the more specific approach of Family Nurture&#xD;
      Intervention (FNI). In addition to receiving standard care, NICU families assigned to FNI&#xD;
      received added intervention that focused on supporting the parents and facilitating emotional&#xD;
      connection between mother and infant during the infant's NICU stay.&#xD;
&#xD;
      The investigators wish to conduct an effectiveness trial to evaluate if the family nurture&#xD;
      intervention's findings can be replicated on a unit-wide level. This effectiveness trial will&#xD;
      take place over two parts. There will be two groups; standard care (SC) and intervention&#xD;
      (FNI). Phase 1 of the effectiveness study will evaluate the standard care (SC) group in the&#xD;
      unit as a baseline measurement and point of comparison to determine if unit-wide FNI&#xD;
      reproduces its prior findings (Phase 2). The standard care group (Phase 1) will receive the&#xD;
      current standard of care in the NICU. In Phase 2, FNI will be implemented unit-wide, but&#xD;
      infants born between 26 weeks and 0 days to 33 weeks 6 days gestation will be eligible to be&#xD;
      enrolled into the study. In addition to receiving standard care, patients enrolled during&#xD;
      phase 2 will receive added interventions from the trained FNI nursing staff. These added&#xD;
      interventions will include supporting the parents and facilitating contact between mother and&#xD;
      infant during their infant's NICU stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2017</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 19, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EEG Power in the frontal polar region</measure>
    <time_frame>Up to 41 weeks gestational age</time_frame>
    <description>Measured in microvolts (µV)^2 for infants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EEG Coherence in the left frontal polar to right frontal polar region</measure>
    <time_frame>Up to 41 weeks gestational age</time_frame>
    <description>Coherence is a number between 0-1, generated by looking at the similarity/differences in activity between brain regions through analysis of EEG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CES-D Score</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>To examine maternal depression, the Center for Epidemiologic Studies Depression Scale (CES-D) is a 20 item self-report inventory designed to assess current but nonspecific distress rather than clinically diagnosed depression. It is the most frequently used measure in the field of infant research and maternal depression. Items probe for depressive symptoms and attitudes within the past week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory (STAI) Score</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>To examine Maternal Anxiety, the State-Trait Anxiety Inventory (STAI) comprises 2 separate self-report scales of 20 items each that measure state and trait anxiety. The S-Anxiety Scale (measuring state), has been found to be a sensitive indicator of changes in transitory anxiety experienced by patients in counseling, psychotherapy, and behavior-modification programs, and has been used to assess the level of anxiety induced by unavoidable real-life stressors. The T-Anxiety scale has proven useful for identifying persons who differ in motivation or drive level. The STAI has been used in studies examining parents of hospitalized children, the transition to a maternal role, perception of illness severity in infants, and maternal anxiety during pregnancy and fetal attachment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurobehavioral Assessments of Infants - Bayley Scales or Infant and Toddler Development, Bayley III</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>At the 18 month corrected age follow-up, infants are administered the Bayley Scales of Infant and Toddler Development, Bayley III consisting of three developmental domains: Cognitive, Language (receptive/expressive) and Motor (fine/gross). For each domain, a composite score is provided and is scaled to a mean score of 100 and a standard deviation of 15. A child will receive 1 point for every item successfully completed. The administration of each section will end if the child received 0 points on 5 consecutive items. Scores &lt;70 indicate significant developmental delays and scores &lt;80 indicate mild to moderate developmental delays.&#xD;
Cognitive Scale - comprised of 91 items Language Scale - comprised of 97 items Motor Scale - comprised of 138 items</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Welch Emotional Connection Scale</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>To examine Mother-Infant Emotional Connection, this is a brief 4-item assessment requiring 5 minutes or less, which assesses the character of the relationship between study mothers and infants. It is filled out by study staff who rate mothers and infants in a dyadic interaction on their attraction, their vocal communication, facial expressiveness, and sensitivity and responsivity towards each other.</description>
  </other_outcome>
  <other_outcome>
    <measure>Child Behavior Checklist Score</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>The Child Behavior Checklist (CBCL) is a device by which parents rate their child's problem behaviors and competencies. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The CBCL consists of 100 items. This will be administered at the 18 Months CA Follow-Up.</description>
  </other_outcome>
  <other_outcome>
    <measure>Modified Checklist for Autism in Toddlers (M-CHAT) Score</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>The M-CHAT is a questionnaire validated for screening toddlers to assess risk for autism spectrum disorders (ASD). It is a 23 yes/no item questionnaire administered to the mother which can be scored in less than 2 minutes. This will be administered at the 18 Month CA Follow-Up.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Premature Birth</condition>
  <condition>Obstetric Labor, Premature</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants enrolled in Phase 1 will be receiving the current standard of care in the NICU at The Valley Hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Family Nurture Intervention (FNI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants enrolled in Phase 2 will be receiving family nurture intervention (FNI) that focuses on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care - Case Studies</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants enrolled as case studies in Phase 1 will be receiving the current standard of care in the NICU at The Valley Hospital. These participants will be those who fall outside the inclusion criteria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FNI - Case Studies</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants enrolled in Phase 2 will be receiving family nurture intervention (FNI) that focuses on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay. These fall outside the inclusion criteria but act as a comparator to the case studies of Phase 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family Nurture Intervention (FNI)</intervention_name>
    <description>Subjects will be guided by the nursing staff through an enhanced program of mother/infant interactions, which include skin-to-skin holding.</description>
    <arm_group_label>FNI - Case Studies</arm_group_label>
    <arm_group_label>Family Nurture Intervention (FNI)</arm_group_label>
    <other_name>FNI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Established routine care provided on the NICU floor by specially trained health care professionals.</description>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_label>Standard Care - Case Studies</arm_group_label>
    <other_name>SC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For the Standard Care and FNI Groups&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  infant is between 26 and 33 6/7 weeks gestational age upon admission&#xD;
&#xD;
          -  infant is a singleton or twin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infant's attending physician does not recommend enrollment in the study&#xD;
&#xD;
          -  severe congenital anomalies including chromosomal anomalies&#xD;
&#xD;
          -  ultrasound evidence of large parenchymal hemorrhagic infarction (&gt;2 cm,&#xD;
             intraventricular hemorrhage grade 3 or 4)&#xD;
&#xD;
          -  infant cardiac anomalies&#xD;
&#xD;
          -  mother has known history of substance abuse, severe psychiatric illness or psychosis&#xD;
&#xD;
          -  status of enrolled subject changes and subject now falls into exclusion criteria&#xD;
&#xD;
          -  mother and/or infant has a medical condition that precludes intervention components&#xD;
&#xD;
          -  mother and/or infant has a contagion that endangers other participants in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>26 Weeks</minimum_age>
    <maximum_age>34 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martha G Welch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Valley Hospital</name>
      <address>
        <city>Ridgewood</city>
        <state>New Jersey</state>
        <zip>07450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morgan Stanley Children's Hospital of New York (MSCHONY)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Martha G Welch</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)</investigator_title>
  </responsible_party>
  <keyword>preterm birth</keyword>
  <keyword>NICU</keyword>
  <keyword>neonatal</keyword>
  <keyword>skin to skin</keyword>
  <keyword>kangaroo care</keyword>
  <keyword>separation stress</keyword>
  <keyword>family nurture</keyword>
  <keyword>maternal confidence</keyword>
  <keyword>maternal competence</keyword>
  <keyword>calming cycle</keyword>
  <keyword>infant neurodevelopment</keyword>
  <keyword>infant psychological development</keyword>
  <keyword>mother-infant co-regulation</keyword>
  <keyword>postpartum depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Obstetric Labor, Premature</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03267043
org study id: AAAR4899
nct id: NCT03267043
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare neurodevelopment and activity in infants born preterm
      (25 to 34 1/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture
      Intervention (FNI) in the neonatal intensive care unit (NICU).

      The investigators hypothesize that FNI will improve: i) neonatal electroencephalographic
      activity ii) maternal caregiving and wellbeing (psychological and physiological, and iii)
      infant behavior and neurodevelopment at 18 months corrected age (CA).

      The two-phase effectiveness study aims to:

        -  Phase 1 - Examine the existing Standard Care Approximately 35 infants and their mothers

        -  Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby
           receives the intervention Approximately 35 infants and their mothers
This study aims to build upon the findings of the earlier randomized controlled trial (RCT)
      conducted at the Columbia University Medical Center (CUMC) comparing effects, both
      physiological and emotional, of the current standard method of encouraging contact between
      mothers and their babies in the NICU with the more specific approach of Family Nurture
      Intervention (FNI). In addition to receiving standard care, NICU families assigned to FNI
      received added intervention that focused on supporting the parents and facilitating emotional
      connection between mother and infant during the infant's NICU stay.

      The investigators wish to conduct an effectiveness trial to evaluate if the family nurture
      intervention's findings can be replicated on a unit-wide level. This effectiveness trial will
      take place over two parts. There will be two groups; standard care (SC) and intervention
      (FNI). Phase 1 of the effectiveness study will evaluate the standard care (SC) group in the
      unit as a baseline measurement and point of comparison to determine if unit-wide FNI
      reproduces its prior findings (Phase 2). The standard care group (Phase 1) will receive the
      current standard of care in the NICU. In Phase 2, FNI will be implemented unit-wide, but
      infants born between 26 weeks and 0 days to 33 weeks 6 days gestation will be eligible to be
      enrolled into the study. In addition to receiving standard care, patients enrolled during
      phase 2 will receive added interventions from the trained FNI nursing staff. These added
      interventions will include supporting the parents and facilitating contact between mother and
      infant during their infant's NICU stay.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: EEG Power in the frontal polar region
time frame: Up to 41 weeks gestational age
description: Measured in microvolts (µV)^2 for infants.
measure: EEG Coherence in the left frontal polar to right frontal polar region
time frame: Up to 41 weeks gestational age
description: Coherence is a number between 0-1, generated by looking at the similarity/differences in activity between brain regions through analysis of EEG.
measure: CES-D Score
time frame: Up to 18 months
description: To examine maternal depression, the Center for Epidemiologic Studies Depression Scale (CES-D) is a 20 item self-report inventory designed to assess current but nonspecific distress rather than clinically diagnosed depression. It is the most frequently used measure in the field of infant research and maternal depression. Items probe for depressive symptoms and attitudes within the past week.
measure: State-Trait Anxiety Inventory (STAI) Score
time frame: Up to 18 months
description: To examine Maternal Anxiety, the State-Trait Anxiety Inventory (STAI) comprises 2 separate self-report scales of 20 items each that measure state and trait anxiety. The S-Anxiety Scale (measuring state), has been found to be a sensitive indicator of changes in transitory anxiety experienced by patients in counseling, psychotherapy, and behavior-modification programs, and has been used to assess the level of anxiety induced by unavoidable real-life stressors. The T-Anxiety scale has proven useful for identifying persons who differ in motivation or drive level. The STAI has been used in studies examining parents of hospitalized children, the transition to a maternal role, perception of illness severity in infants, and maternal anxiety during pregnancy and fetal attachment.
measure: Neurobehavioral Assessments of Infants - Bayley Scales or Infant and Toddler Development, Bayley III
time frame: Up to 18 months
description: At the 18 month corrected age follow-up, infants are administered the Bayley Scales of Infant and Toddler Development, Bayley III consisting of three developmental domains: Cognitive, Language (receptive/expressive) and Motor (fine/gross). For each domain, a composite score is provided and is scaled to a mean score of 100 and a standard deviation of 15. A child will receive 1 point for every item successfully completed. The administration of each section will end if the child received 0 points on 5 consecutive items. Scores <70 indicate significant developmental delays and scores <80 indicate mild to moderate developmental delays.
Cognitive Scale - comprised of 91 items Language Scale - comprised of 97 items Motor Scale - comprised of 138 items
measure: Welch Emotional Connection Scale
time frame: Up to 18 months
description: To examine Mother-Infant Emotional Connection, this is a brief 4-item assessment requiring 5 minutes or less, which assesses the character of the relationship between study mothers and infants. It is filled out by study staff who rate mothers and infants in a dyadic interaction on their attraction, their vocal communication, facial expressiveness, and sensitivity and responsivity towards each other.
measure: Child Behavior Checklist Score
time frame: Up to 18 months
description: The Child Behavior Checklist (CBCL) is a device by which parents rate their child's problem behaviors and competencies. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The CBCL consists of 100 items. This will be administered at the 18 Months CA Follow-Up.
measure: Modified Checklist for Autism in Toddlers (M-CHAT) Score
time frame: Up to 18 months
description: The M-CHAT is a questionnaire validated for screening toddlers to assess risk for autism spectrum disorders (ASD). It is a 23 yes/no item questionnaire administered to the mother which can be scored in less than 2 minutes. This will be administered at the 18 Month CA Follow-Up.
arm group label: Standard Care
arm group type: Active Comparator
description: Participants enrolled in Phase 1 will be receiving the current standard of care in the NICU at The Valley Hospital.
arm group label: Family Nurture Intervention (FNI)
arm group type: Experimental
description: Participants enrolled in Phase 2 will be receiving family nurture intervention (FNI) that focuses on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay.
arm group label: Standard Care - Case Studies
arm group type: Active Comparator
description: Participants enrolled as case studies in Phase 1 will be receiving the current standard of care in the NICU at The Valley Hospital. These participants will be those who fall outside the inclusion criteria.
arm group label: FNI - Case Studies
arm group type: Experimental
description: Participants enrolled in Phase 2 will be receiving family nurture intervention (FNI) that focuses on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay. These fall outside the inclusion criteria but act as a comparator to the case studies of Phase 1.
intervention type: Behavioral
intervention name: Family Nurture Intervention (FNI)
description: Subjects will be guided by the nursing staff through an enhanced program of mother/infant interactions, which include skin-to-skin holding.
arm group label: FNI - Case Studies
arm group label: Family Nurture Intervention (FNI)
other name: FNI
intervention type: Behavioral
intervention name: Standard Care
description: Established routine care provided on the NICU floor by specially trained health care professionals.
arm group label: Standard Care
arm group label: Standard Care - Case Studies
other name: SC
criteria: 
gender: All
minimum age: 26 Weeks
maximum age: 34 Weeks
healthy volunteers: No
last name: Martha G Welch, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Martha G Welch
investigator title: Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)
mesh term: Premature Birth
mesh term: Obstetric Labor, Premature
sharing ipd: Undecided