<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/NCT03010891</url>
  </required_header>
  <id_info>
    <org_study_id>2-104-05-157</org_study_id>
    <nct_id>NCT03010891</nct_id>
  </id_info>
  <brief_title>Effects of Bundled Supportive Interventions on Preterm Infants' Stress-Related Outcomes During Invasive Procedures</brief_title>
  <official_title>Effects of Bundled Supportive Interventions on Preterm Infants' Stress-Related Outcomes</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>
      The proposed 2-year study has two specific aims: (1) to examine the effects of a &quot;bundle&quot; of&#xD;
      supportive interventions on preterm infants' stress (salivary cortisol and&#xD;
      dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep,&#xD;
      and physical activity in the NICU, and (2) to explore the relationships among preterm&#xD;
      infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep,&#xD;
      and physical activity. This randomized controlled trial will adopt a longitudinal&#xD;
      repeated-measures design to examine the effects of bundled supportive interventions on&#xD;
      preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and&#xD;
      physiological signals of infant distress [using bedside electrocardiographic monitors]),&#xD;
      sleep and physical activity (using ankle actigraphy) during their NICU hospitalization.&#xD;
      Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two&#xD;
      conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine&#xD;
      kangaroo mother care (KMC) &lt; 20 minutes; (2) experimental condition: the bundle of supportive&#xD;
      interventions (usual NICU care +positioning + gentle touch + modulating infant states +&#xD;
      facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC &gt; 45 minutes. Outcome&#xD;
      variables will include infants' biological responses to stress (salivary cortisol, salivary&#xD;
      DHEA, and physiological signals of infant distress), sleep patterns, and physical activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and purpose: Preterm infants need to receive intensive care in a neonatal&#xD;
      intensive care unit (NICU) to survive, but this care exposes them to painful procedures and a&#xD;
      stressful environment. Repeated, painful/stressful stimuli can disturb infants' sleep, change&#xD;
      their physiological indicators, and affect their developing brain and organs, possibly&#xD;
      resulting in negative, long-lasting developmental consequences. Therefore, NICU clinicians&#xD;
      caring for these vulnerable infants have two important goals: to provide early interventions&#xD;
      to minimize preterm infants' stress/pain and to improve their sleep and physical activity.&#xD;
      The proposed 2-year study has two specific aims: (1) to examine the effects of a &quot;bundle&quot; of&#xD;
      supportive interventions on preterm infants' stress (salivary cortisol and&#xD;
      dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep,&#xD;
      and physical activity in the NICU, and (2) to explore the relationships among preterm&#xD;
      infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep,&#xD;
      and physical activity.&#xD;
&#xD;
      Methods: This randomized controlled trial will adopt a longitudinal repeated-measures design&#xD;
      to examine the effects of bundled supportive interventions on preterm infants' stress&#xD;
      (salivary cortisol and DHEA levels [using ELISA kit] and physiological signals of infant&#xD;
      distress [using bedside electrocardiographic monitors]), sleep and physical activity (using&#xD;
      ankle actigraphy) during their NICU hospitalization. Preterm infants (N=120) meeting the&#xD;
      study criteria will be randomly assigned to one of two conditions: (1) control condition:&#xD;
      usual NICU care + positioning + gentle touch +routine kangaroo mother care (KMC) &lt; 20&#xD;
      minutes; (2) experimental condition: the bundle of supportive interventions (usual NICU care&#xD;
      +positioning + gentle touch + modulating infant states + facilitated tucking + non-nutritive&#xD;
      sucking + oral sucrose+ routine KMC &gt; 45 minutes. Outcome variables will include infants'&#xD;
      biological responses to stress (salivary cortisol, salivary DHEA, and physiological signals&#xD;
      of infant distress), sleep patterns, and physical activity.&#xD;
&#xD;
      Expected outcomes: The study will fill a gap in knowledge about the effects of bundled&#xD;
      supportive interventions on preterm infants' stress reactivity, sleep, and physical activity&#xD;
      during hospitalization. This unique combination of physiological measurements of preterm&#xD;
      infants' stress parameters and longitudinal design will provide results for establishing&#xD;
      evidence-based clinical guidelines to provide atraumatic care to this population during&#xD;
      intrusive procedures. Investigators also expect that bundling supportive interventions will&#xD;
      minimize preterm infants' pain/stress as well as improve their sleep and physical activity.&#xD;
      In the long term, the study results may help reduce the morbidity and complications due to&#xD;
      preterm birth, save medical costs in neonatal care, and promote these infants' health and&#xD;
      future developmental outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">August 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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preterm infant salivary cortisol</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Accessed by salivary cortisol ELISA kit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preterm infant sleep</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Accessed by Actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preterm infant physiological signals of infant distress</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Accessed by bedside electrocardiographic monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All preterm infants' physical activity are accessed by using Actigraphy</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Accessed by Actigraphy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preterm infant salivary DHEA levels</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Accessed by salivary DHEA ELISA kit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Preterm Infants</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>control condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preterm infants in the control condition will receive only usual NICU care, plus positioning and gentle touch during intrusive procedures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>experimental condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The bundle of supportive interventions will be designed to alleviate preterm infants' stress/pain from birth to discharge from the hospital NICU.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The bundle of supportive interventions</intervention_name>
    <description>usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + NNS+ oral sucrose+ routine KMC &gt; 45 minutes</description>
    <arm_group_label>experimental condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual NICU care</intervention_name>
    <description>usual NICU care + positioning + gentle touch +routine KMC &lt; 20 minutes</description>
    <arm_group_label>control condition</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) birth weight &lt; 2100g&#xD;
&#xD;
          -  (3) stable condition (score &lt; 22 on the Neonatal Therapeutic Intervention Scoring&#xD;
             System [NTISS] for disease severity)&#xD;
&#xD;
          -  (4) parents can speak, read and write Chinese&#xD;
&#xD;
          -  (5) parents have no history of drug/alcohol abuse&#xD;
&#xD;
          -  (6) parents agree to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) congenital anomalies&#xD;
&#xD;
          -  (2) neurologic impairment including convulsion, intraventricular hemorrhage &gt; grade II&#xD;
             or 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>37 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jen-Jiuan Liaw, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Professor, School of Nursing, 1National 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 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 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>Preterm infant</keyword>
  <keyword>Stress</keyword>
  <keyword>Salivary DHEA</keyword>
  <keyword>Salivary cortisol</keyword>
  <keyword>Actigraphy</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/NCT03010891
org study id: 2-104-05-157
nct id: NCT03010891
lead sponsor: 
collaborator: 
has dmc: Yes
The proposed 2-year study has two specific aims: (1) to examine the effects of a "bundle" of
      supportive interventions on preterm infants' stress (salivary cortisol and
      dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep,
      and physical activity in the NICU, and (2) to explore the relationships among preterm
      infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep,
      and physical activity. This randomized controlled trial will adopt a longitudinal
      repeated-measures design to examine the effects of bundled supportive interventions on
      preterm infants' stress (salivary cortisol and DHEA levels [using ELISA kit] and
      physiological signals of infant distress [using bedside electrocardiographic monitors]),
      sleep and physical activity (using ankle actigraphy) during their NICU hospitalization.
      Preterm infants (N=120) meeting the study criteria will be randomly assigned to one of two
      conditions: (1) control condition: usual NICU care + positioning + gentle touch +routine
      kangaroo mother care (KMC) < 20 minutes; (2) experimental condition: the bundle of supportive
      interventions (usual NICU care +positioning + gentle touch + modulating infant states +
      facilitated tucking + non-nutritive sucking + oral sucrose+ routine KMC > 45 minutes. Outcome
      variables will include infants' biological responses to stress (salivary cortisol, salivary
      DHEA, and physiological signals of infant distress), sleep patterns, and physical activity.
Background and purpose: Preterm infants need to receive intensive care in a neonatal
      intensive care unit (NICU) to survive, but this care exposes them to painful procedures and a
      stressful environment. Repeated, painful/stressful stimuli can disturb infants' sleep, change
      their physiological indicators, and affect their developing brain and organs, possibly
      resulting in negative, long-lasting developmental consequences. Therefore, NICU clinicians
      caring for these vulnerable infants have two important goals: to provide early interventions
      to minimize preterm infants' stress/pain and to improve their sleep and physical activity.
      The proposed 2-year study has two specific aims: (1) to examine the effects of a "bundle" of
      supportive interventions on preterm infants' stress (salivary cortisol and
      dehydroepiandrosterone [DHEA] levels and physiological signals of infant distress), sleep,
      and physical activity in the NICU, and (2) to explore the relationships among preterm
      infants' salivary cortisol and DHEA levels, physiological signals of infant distress, sleep,
      and physical activity.

      Methods: This randomized controlled trial will adopt a longitudinal repeated-measures design
      to examine the effects of bundled supportive interventions on preterm infants' stress
      (salivary cortisol and DHEA levels [using ELISA kit] and physiological signals of infant
      distress [using bedside electrocardiographic monitors]), sleep and physical activity (using
      ankle actigraphy) during their NICU hospitalization. Preterm infants (N=120) meeting the
      study criteria will be randomly assigned to one of two conditions: (1) control condition:
      usual NICU care + positioning + gentle touch +routine kangaroo mother care (KMC) < 20
      minutes; (2) experimental condition: the bundle of supportive interventions (usual NICU care
      +positioning + gentle touch + modulating infant states + facilitated tucking + non-nutritive
      sucking + oral sucrose+ routine KMC > 45 minutes. Outcome variables will include infants'
      biological responses to stress (salivary cortisol, salivary DHEA, and physiological signals
      of infant distress), sleep patterns, and physical activity.

      Expected outcomes: The study will fill a gap in knowledge about the effects of bundled
      supportive interventions on preterm infants' stress reactivity, sleep, and physical activity
      during hospitalization. This unique combination of physiological measurements of preterm
      infants' stress parameters and longitudinal design will provide results for establishing
      evidence-based clinical guidelines to provide atraumatic care to this population during
      intrusive procedures. Investigators also expect that bundling supportive interventions will
      minimize preterm infants' pain/stress as well as improve their sleep and physical activity.
      In the long term, the study results may help reduce the morbidity and complications due to
      preterm birth, save medical costs in neonatal care, and promote these infants' health and
      future developmental outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Preterm infant salivary cortisol
time frame: up to 3 months
description: Accessed by salivary cortisol ELISA kit
measure: Preterm infant sleep
time frame: up to 3 months
description: Accessed by Actigraphy
measure: Preterm infant physiological signals of infant distress
time frame: up to 3 months
description: Accessed by bedside electrocardiographic monitor
measure: All preterm infants' physical activity are accessed by using Actigraphy
time frame: up to 3 months
description: Accessed by Actigraphy
measure: Preterm infant salivary DHEA levels
time frame: up to 3 months
description: Accessed by salivary DHEA ELISA kit
arm group label: control condition
arm group type: Active Comparator
description: Preterm infants in the control condition will receive only usual NICU care, plus positioning and gentle touch during intrusive procedures.
arm group label: experimental condition
arm group type: Experimental
description: The bundle of supportive interventions will be designed to alleviate preterm infants' stress/pain from birth to discharge from the hospital NICU.
intervention type: Behavioral
intervention name: The bundle of supportive interventions
description: usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + NNS+ oral sucrose+ routine KMC > 45 minutes
arm group label: experimental condition
intervention type: Behavioral
intervention name: Usual NICU care
description: usual NICU care + positioning + gentle touch +routine KMC < 20 minutes
arm group label: control condition
criteria: 
gender: All
minimum age: 28 Weeks
maximum age: 37 Weeks
healthy volunteers: No
last name: Jen-Jiuan Liaw, Professor
role: Study Chair
affiliation: Professor, School of Nursing, 1National 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