<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/NCT03023267</url>
  </required_header>
  <id_info>
    <org_study_id>0283-15-MMC</org_study_id>
    <nct_id>NCT03023267</nct_id>
  </id_info>
  <brief_title>The Contribution of Parent-infant Interaction While Singing During Kangaroo Care, on Preterm-infants' Autonomic Stability and Parental Anxiety Reduction</brief_title>
  <official_title>Open Randomized Study on the Effect of Applying Music Therapy by Therapist in the Neonatal Intensive Care Unit (NICU).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>No</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 current study will investigate the combination of the two modalities in a mixed-methods&#xD;
      design, in order to provide comprehensive knowledge regarding the effects of family-centered&#xD;
      MT during KC, on premature-infants' autonomic nervous system stability (measured by&#xD;
      parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety&#xD;
      levels; And parents' unique experiences of the intervention. Additionally, the study will&#xD;
      analyze separately mothers and fathers to elucidate similar and different effects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Premature infants and their parents are prone to high anxiety levels and a risk of&#xD;
      experiencing trauma due to the preterm birth and its implications. Facing various emotional&#xD;
      physical and neural high-risk factors may lead to continuous stress reactions in both the&#xD;
      infant and parents, affecting their well being, the parent-infant relationship and the&#xD;
      infant's medical state outcome. Attending to both infants' emotional and physiological needs&#xD;
      of stability and comfort, as well as parents' support, can lead to an improvement in the&#xD;
      premature infants' medical state and the parent-infant bonding process. Furthermore, reducing&#xD;
      stress reaction facilitates perceptual memory and learning in premature infants. Two well&#xD;
      established interventions in the neonatal care aiming to address the varied premature-family&#xD;
      needs are Kangaroo care (KC) and Music Therapy (MT). Various research and clinical reports&#xD;
      over the last three decades, regarding each modality, has shown beneficial effects in&#xD;
      improvement and stabilization of infants' medical state, inclusion of parents in their&#xD;
      infants' treatment and in facilitation of meaningful parent-infant interactions to promoting&#xD;
      bonding patterns. However, a major lack of rigorous Randomized control studies presenting the&#xD;
      clinical applications of MT techniques and methods in the NICU care exists, as well as only&#xD;
      few research have positioned the parents in center of investigation, and/or presented their&#xD;
      outcome and perspective. Accordingly, only few research have investigated the combination of&#xD;
      MT and KC through an RCT. The current study will investigate the combination of the two&#xD;
      modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding&#xD;
      the effects of family-centered MT during KC, on premature-infants' autonomic nervous system&#xD;
      stability (measured by parasympathetic tone, physiological vital signs and behavioral&#xD;
      states); Parents' anxiety levels; And parents' unique experiences of the intervention.&#xD;
      Additionally, the study will analyze separately mothers and fathers to elucidate similar and&#xD;
      different effects&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">October 10, 2019</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>parasympathetic tone</measure>
    <time_frame>During intervention of music and\or kangaroo care which will carry on once during 32-36 weeks gestation and once at 3 months corrected age</time_frame>
    <description>The electrocardiogram analogue signal from a cardiorespiratory monitor fed into a computer containing the Heart Rate Variability (HRV) software (ANSR1000 system Ansar, Inc., Philadelphia, Pennsylvania , USA). The analogue electrocardiogram signal is converted to digital values reflecting cyclic changes in the RR interval. The data is transformed into a waveform across a spectrum of various frequencies. Frequencies measured in hertz (1 Hz = 1 cycle/sec). Applied to variability, The high frequency (HF) power spectrum is in the frequency range of &gt;0.15-1.80 Hz, which is predominately influenced by parasympathetic inputs.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>PreTerm Birth</condition>
  <condition>Stress Reaction</condition>
  <arm_group>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Applying music therapy with kangaroo care to mothers and fathers during their NICU hospitalization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Applying only Kangaroo care to mothers and fathers during their stay in the NICU</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Music therapy and Kangaroo care</intervention_name>
    <description>Mother holding baby in skin to skin position while singing</description>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Kangaroo Care alone</intervention_name>
    <description>Mother holding baby in skin to skin position without singing</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Preterm infants ≤ 37 weeks' gestation&#xD;
&#xD;
          2. Clinically stable preterm&#xD;
&#xD;
          3. Hearing confirmed by distortion product oto- acoustic emissions&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Preterm infants treated with Central Nervous System (CNS) related medication (Luminal,&#xD;
             Oxygen)&#xD;
&#xD;
          2. Infants with Intraventricular hemorrhage stage ≥ 3, Peri ventricular Leukomalacia&#xD;
&#xD;
          3. Parents refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Weeks</minimum_age>
    <maximum_age>18 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Grause, RD</last_name>
    <role>Study Chair</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neonatal Intensive Care Unit</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>February 23, 2020</last_update_submitted>
  <last_update_submitted_qc>February 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meir Medical Center</investigator_affiliation>
    <investigator_full_name>Shmuel Arnon</investigator_full_name>
    <investigator_title>Senior Neonatologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Fractures, Stress</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/NCT03023267
org study id: 0283-15-MMC
nct id: NCT03023267
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current study will investigate the combination of the two modalities in a mixed-methods
      design, in order to provide comprehensive knowledge regarding the effects of family-centered
      MT during KC, on premature-infants' autonomic nervous system stability (measured by
      parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety
      levels; And parents' unique experiences of the intervention. Additionally, the study will
      analyze separately mothers and fathers to elucidate similar and different effects
Premature infants and their parents are prone to high anxiety levels and a risk of
      experiencing trauma due to the preterm birth and its implications. Facing various emotional
      physical and neural high-risk factors may lead to continuous stress reactions in both the
      infant and parents, affecting their well being, the parent-infant relationship and the
      infant's medical state outcome. Attending to both infants' emotional and physiological needs
      of stability and comfort, as well as parents' support, can lead to an improvement in the
      premature infants' medical state and the parent-infant bonding process. Furthermore, reducing
      stress reaction facilitates perceptual memory and learning in premature infants. Two well
      established interventions in the neonatal care aiming to address the varied premature-family
      needs are Kangaroo care (KC) and Music Therapy (MT). Various research and clinical reports
      over the last three decades, regarding each modality, has shown beneficial effects in
      improvement and stabilization of infants' medical state, inclusion of parents in their
      infants' treatment and in facilitation of meaningful parent-infant interactions to promoting
      bonding patterns. However, a major lack of rigorous Randomized control studies presenting the
      clinical applications of MT techniques and methods in the NICU care exists, as well as only
      few research have positioned the parents in center of investigation, and/or presented their
      outcome and perspective. Accordingly, only few research have investigated the combination of
      MT and KC through an RCT. The current study will investigate the combination of the two
      modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding
      the effects of family-centered MT during KC, on premature-infants' autonomic nervous system
      stability (measured by parasympathetic tone, physiological vital signs and behavioral
      states); Parents' anxiety levels; And parents' unique experiences of the intervention.
      Additionally, the study will analyze separately mothers and fathers to elucidate similar and
      different effects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: parasympathetic tone
time frame: During intervention of music and\or kangaroo care which will carry on once during 32-36 weeks gestation and once at 3 months corrected age
description: The electrocardiogram analogue signal from a cardiorespiratory monitor fed into a computer containing the Heart Rate Variability (HRV) software (ANSR1000 system Ansar, Inc., Philadelphia, Pennsylvania , USA). The analogue electrocardiogram signal is converted to digital values reflecting cyclic changes in the RR interval. The data is transformed into a waveform across a spectrum of various frequencies. Frequencies measured in hertz (1 Hz = 1 cycle/sec). Applied to variability, The high frequency (HF) power spectrum is in the frequency range of >0.15-1.80 Hz, which is predominately influenced by parasympathetic inputs.
arm group label: Interventional
arm group type: Experimental
description: Applying music therapy with kangaroo care to mothers and fathers during their NICU hospitalization
arm group label: Control
arm group type: Active Comparator
description: Applying only Kangaroo care to mothers and fathers during their stay in the NICU
intervention type: Behavioral
intervention name: Music therapy and Kangaroo care
description: Mother holding baby in skin to skin position while singing
arm group label: Interventional
intervention type: Behavioral
intervention name: Kangaroo Care alone
description: Mother holding baby in skin to skin position without singing
arm group label: Control
criteria: 
gender: All
minimum age: 4 Weeks
maximum age: 18 Weeks
healthy volunteers: No
last name: Rachel Grause, RD
role: Study Chair
affiliation: Meir Medical Center
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Meir Medical Center
investigator full name: Shmuel Arnon
investigator title: Senior Neonatologist
mesh term: Premature Birth
mesh term: Fractures, Stress
sharing ipd: No