<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/NCT03013023</url>
  </required_header>
  <id_info>
    <org_study_id>1-103-05-165</org_study_id>
    <nct_id>NCT03013023</nct_id>
  </id_info>
  <brief_title>Effects of Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being</brief_title>
  <official_title>Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Defense Medical Center, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Defense Medical Center, Taiwan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled trial will use a longitudinal repeated-measures design to examine&#xD;
      the effects of two interventions, behavioral support interventions and a parent-infant&#xD;
      transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions,&#xD;
      and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional&#xD;
      regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study has five specific aims:&#xD;
&#xD;
        1. to develop behavioral-support interventions for preterm infants who receive painful,&#xD;
           stressful procedures in the NICU,&#xD;
&#xD;
        2. to develop a parent-infant transactional program (PITP) for parent-infant dyads with&#xD;
           preterm infants in the NICU,&#xD;
&#xD;
        3. to determine the short-term effects of the behavioral-support interventions and PITP on&#xD;
           infant stress (salivary cortisol levels) and sleep patterns,&#xD;
&#xD;
        4. to determine the short-term effects of the PITP on parental stress, depression, social&#xD;
           support, and sleep quality during postpartum, and&#xD;
&#xD;
        5. to determine the long-term effects of the behavioral-support interventions and PITP on&#xD;
           parent-infant interactions and infants' long-term emotional regulation and&#xD;
           neurobehavioral outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parent stress</measure>
    <time_frame>7days to 12 months</time_frame>
    <description>Accessed by Parenting Stress Index-Short form (PSI-SF)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent depression</measure>
    <time_frame>7days to 12 months</time_frame>
    <description>Accessed by the Edinburgh Postnatal Depression Scale (EPDS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent sleep</measure>
    <time_frame>7days to 12 months</time_frame>
    <description>Accessed by Pittsburgh Sleep Quality Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent social support</measure>
    <time_frame>7days to 12 months</time_frame>
    <description>Accessed by the Social Support Rating Scale (SSRS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parent-infant interaction</measure>
    <time_frame>1 month to 6 months</time_frame>
    <description>Assessed by NCASTfeeding scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preterm infant's sleep</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Assessed by Actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preterm infant's stress</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Assessed by Salivary cortisol</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Early Interventions</condition>
  <condition>Preterm Infants</condition>
  <condition>Parent-Child Relations</condition>
  <arm_group>
    <arm_group_label>Routine care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Behavioral-support interventions (BS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NNS, FT, positional support, and oral sucrose feeding will be provided while infants are undergoing painful procedures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parent-infant transaction program (PITP)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The PITP will be a six-session, one-on-one teaching intervention beginning on day 22 after birth, with four sessions at bedside, and two home-visit sessions within the first month after discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BS+PITP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Behavioral-support interventions + Parent-infant transaction program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BS</intervention_name>
    <description>NNS, FT, positional support, and oral sucrose feeding</description>
    <arm_group_label>Behavioral-support interventions (BS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Routine care</intervention_name>
    <description>Routine NICU care</description>
    <arm_group_label>Routine care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PITP</intervention_name>
    <description>Parents will learn to regulate infant responses while implementing caregiving activities.</description>
    <arm_group_label>Parent-infant transaction program (PITP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BS+PITP</intervention_name>
    <description>Parents will learn to regulate infant responses while implementing caregiving activities. Supportive interventions, i.e., NNS, FT, positional support, and oral sucrose feeding, will be provided while infants are undergoing painful procedures.</description>
    <arm_group_label>BS+PITP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Gestational age (GA) &gt; 28 weeks and &lt; 37 weeks&#xD;
&#xD;
          2. Postbirth age &gt;2 days&#xD;
&#xD;
          3. Stable condition (score&lt;20 on the Neonatal Therapeutic Intervention Scoring System&#xD;
             [NTISS] for disease severity).&#xD;
&#xD;
          4. Parents are not diagnosed with mental illness or some other illness known to&#xD;
             influence/confound the outcome variables&#xD;
&#xD;
          5. Parents are fluent in Chinese&#xD;
&#xD;
          6. Parents do not use drugs&#xD;
&#xD;
          7. Parents agree to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Congenital anomalies&#xD;
&#xD;
          2. Neurologic impairment including convulsion, intraventricular hemorrhage &gt; grade II or&#xD;
             periventricular leukomalacia&#xD;
&#xD;
          3. Documented congenital or nosocomial (infection acquired at hospital after birth)&#xD;
             sepsis&#xD;
&#xD;
          4. Surgery&#xD;
&#xD;
          5. Severe medical conditions requiring treatments such as cortisol supplementation,&#xD;
             sedatives, muscle relaxants, antiepileptic, or analgesic drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Weeks</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jen-Jiuan Liaw, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan, ROC.</affiliation>
  </overall_official>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>October 31, 2020</last_update_submitted>
  <last_update_submitted_qc>October 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Defense Medical Center, Taiwan</investigator_affiliation>
    <investigator_full_name>Hsiang-Yun Lan</investigator_full_name>
    <investigator_title>Investigator, National Defense Medical Center, Taiwan</investigator_title>
  </responsible_party>
  <keyword>Behavioral and Transaction Interventions</keyword>
  <keyword>Parents' Biopsychosocial Well-being</keyword>
  <keyword>Preterm Infants</keyword>
  <keyword>Sleep</keyword>
  <keyword>Salivary cortisol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</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/NCT03013023
org study id: 1-103-05-165
nct id: NCT03013023
lead sponsor: 
collaborator: 
has dmc: Yes
This randomized controlled trial will use a longitudinal repeated-measures design to examine
      the effects of two interventions, behavioral support interventions and a parent-infant
      transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions,
      and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional
      regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.
The proposed study has five specific aims:

        1. to develop behavioral-support interventions for preterm infants who receive painful,
           stressful procedures in the NICU,

        2. to develop a parent-infant transactional program (PITP) for parent-infant dyads with
           preterm infants in the NICU,

        3. to determine the short-term effects of the behavioral-support interventions and PITP on
           infant stress (salivary cortisol levels) and sleep patterns,

        4. to determine the short-term effects of the PITP on parental stress, depression, social
           support, and sleep quality during postpartum, and

        5. to determine the long-term effects of the behavioral-support interventions and PITP on
           parent-infant interactions and infants' long-term emotional regulation and
           neurobehavioral outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Parent stress
time frame: 7days to 12 months
description: Accessed by Parenting Stress Index-Short form (PSI-SF)
measure: Parent depression
time frame: 7days to 12 months
description: Accessed by the Edinburgh Postnatal Depression Scale (EPDS)
measure: Parent sleep
time frame: 7days to 12 months
description: Accessed by Pittsburgh Sleep Quality Index
measure: Parent social support
time frame: 7days to 12 months
description: Accessed by the Social Support Rating Scale (SSRS)
measure: Parent-infant interaction
time frame: 1 month to 6 months
description: Assessed by NCASTfeeding scale
measure: Preterm infant's sleep
time frame: up to 3 months
description: Assessed by Actigraphy
measure: Preterm infant's stress
time frame: up to 3 months
description: Assessed by Salivary cortisol
arm group label: Routine care
arm group type: Placebo Comparator
description: Control group
arm group label: Behavioral-support interventions (BS)
arm group type: Active Comparator
description: NNS, FT, positional support, and oral sucrose feeding will be provided while infants are undergoing painful procedures
arm group label: Parent-infant transaction program (PITP)
arm group type: Active Comparator
description: The PITP will be a six-session, one-on-one teaching intervention beginning on day 22 after birth, with four sessions at bedside, and two home-visit sessions within the first month after discharge.
arm group label: BS+PITP
arm group type: Active Comparator
description: Behavioral-support interventions + Parent-infant transaction program
intervention type: Behavioral
intervention name: BS
description: NNS, FT, positional support, and oral sucrose feeding
arm group label: Behavioral-support interventions (BS)
intervention type: Behavioral
intervention name: Routine care
description: Routine NICU care
arm group label: Routine care
intervention type: Behavioral
intervention name: PITP
description: Parents will learn to regulate infant responses while implementing caregiving activities.
arm group label: Parent-infant transaction program (PITP)
intervention type: Behavioral
intervention name: BS+PITP
description: Parents will learn to regulate infant responses while implementing caregiving activities. Supportive interventions, i.e., NNS, FT, positional support, and oral sucrose feeding, will be provided while infants are undergoing painful procedures.
arm group label: BS+PITP
criteria: 
gender: All
minimum age: 28 Weeks
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jen-Jiuan Liaw, Professor
role: Study Chair
affiliation: Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan, ROC.
responsible party type: Principal Investigator
investigator affiliation: National Defense Medical Center, Taiwan
investigator full name: Hsiang-Yun Lan
investigator title: Investigator, National Defense Medical Center, Taiwan
mesh term: Premature Birth
sharing ipd: No