<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/NCT02998463</url>
  </required_header>
  <id_info>
    <org_study_id>Bailey /Nov /2016 /RC /0640</org_study_id>
    <nct_id>NCT02998463</nct_id>
  </id_info>
  <brief_title>Facilitating Skin-to-Skin Contact In the Postnatal Period</brief_title>
  <official_title>A Skin-to-Skin Contact (SSC) Facilitating Device Used Within a Mother-Infant Dyad: Exploring Its Acceptability, Usage and Effect on Health Outcomes in the Postnatal Period.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Birmingham City University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Birmingham City University</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>
      This study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by&#xD;
      mother-infant dyads. It has three phases including researcher observation, randomised&#xD;
      controlled trialing and qualitative midwifery staff perspective. The research will determine&#xD;
      the effect a facilitating garment has in comparison to conventionally facilitated&#xD;
      skin-to-skin contact, by measuring its effect on the baby's temperature stability,&#xD;
      breastfeeding status and weight velocity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Skin-to-skin contact is used as part of a package of Kangaroo Mother Care across the world.&#xD;
      This has been demonstrated to reduce neonatal morbidity, mortality, and inpatient stays for&#xD;
      low birth weight and preterm infants (Charpak and Ruiz 2016).&#xD;
&#xD;
      This study examines the effect a facilitating garment, the Snuby® has on neonatal health&#xD;
      outcomes associated with skin-to-skin contact, such as neonatal thermoregulation,&#xD;
      breastfeeding status, and self-reported mother-infant bonding. It uses a mixed methods&#xD;
      approach to address quantitative and qualitative outcomes including participant's&#xD;
      perspectives, and measurable health markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 31, 2017</start_date>
  <completion_date type="Actual">June 20, 2019</completion_date>
  <primary_completion_date type="Actual">June 20, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Abnormal neonatal temperature</measure>
    <time_frame>Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.</time_frame>
    <description>Axillary temperature taken by the mother with Eco Temp Basic thermometer. Abnormal: less than 36.5°C or more than 37.5°C.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Breastfeeding Status</measure>
    <time_frame>Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.</time_frame>
    <description>Exclusive breastfeeding, mixed breast and formula feeding, exclusive formula feeding, addition of expressed breastmilk. Includes a comparison to self reported antenatal infant feeding intentions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mother Infant bonding</measure>
    <time_frame>Six weeks post birth</time_frame>
    <description>Maternal participants will self report on their perspectives of skin-to-skin contact, and its role in the relationship bonding process between themselves and their babies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Weight Velocity</measure>
    <time_frame>At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.</time_frame>
    <description>Neonatal weight in grams to ensure suitable for Snuby® garment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal participant's perspective</measure>
    <time_frame>Weekly until 6 weeks post birth</time_frame>
    <description>Maternal participants will self-report their views on the garment's ease of use and perceived value. This will be compared to the control group reporting on the same outcomes with conventionally facilitated skin-to-skin contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Midwifery participant's perspective</measure>
    <time_frame>12 months post birth of the first participating mother-infant dyad.</time_frame>
    <description>Qualitative data collection from midwifery participants, including their perspectives on skin-to-skin contact in the hospital setting, and the perceived value of the Snuby® garment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Breast Feeding</condition>
  <condition>Body Temperature Changes</condition>
  <arm_group>
    <arm_group_label>Snuby® users</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group receives the Snuby® skin-to-skin facilitating garment to use in the first six weeks following birth with their baby. The use of the Snuby® garment is participant led, and used for as long and as often as they wish in the six week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group does not receive any intervention, and collects data on the research outcomes when having conventionally facilitated skin-to-skin contact, using a towel, blanket, or clothing as preferred. Skin-to-skin contact frequency and duration is dictated by the participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>skin-to-skin facilitating garment</intervention_name>
    <description>Fabric garment designed to accommodate term neonates having skin-to-skin contact.</description>
    <arm_group_label>Snuby® users</arm_group_label>
    <other_name>Snuby®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Maternal participants&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Women, non-binary and transgender participants. Aged 16+ years old. Vaginal birth,&#xD;
        including ventouse, forceps and spontaneous vaginal birth. 28+ weeks pregnant. Body Mass&#xD;
        Index of 18 to 30 inclusive. Births between 37 and 42 completed weeks of pregnancy. Women&#xD;
        without any morbidities that will significantly impair their ability to independently&#xD;
        parent their baby.&#xD;
&#xD;
        Women planning to give birth on the labour ward, co-located birth centre, standalone birth&#xD;
        centre or at home.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Caesarean section births. High dependency Unit patients. Illiterate in English. Multiple&#xD;
        pregnancies e.g. twins. Registered child protection concerns. Substance misusing women.&#xD;
        Body Mass Index of less than 18 at booking appointment. Body Mass Index of more than 30 at&#xD;
        booking appointment. Aged under 16 years old.&#xD;
&#xD;
        Neonatal participants&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        Born 37 to 42 completed weeks gestation. Birth weight between 2500g and 4000g . Weight at&#xD;
        six weeks of age less than 6000g. Neonates requiring blood glucose prefeed monitoring. From&#xD;
        birth to six weeks of age.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Preterm neonates (less than 37 weeks gestation). Requirement for special or intensive&#xD;
        neonatal care. Receiving phototherapy. Receiving intravenous antibiotics. Falling growth&#xD;
        velocity of more than 2 centiles. Aged over 6 weeks old.&#xD;
&#xD;
        Midwifery staff participants&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Working at the National Health Service Trust hosting the research. Working through the&#xD;
        Hospital Bank. Registered midwife through the Nursing and Midwifery Council. Working on&#xD;
        band 5, 6 or 7. Working within the hospital setting.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Midwifery staff working in the community without rotating to the hospital wards.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helen McIntyre, DHSci</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leicester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Birmingham City University</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 3TN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sandwell and West Birmingham NHS Trust</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 3TN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Charpak N, Ruiz JG. Latin American Clinical Epidemiology Network Series - Paper 9: The Kangaroo Mother Care Method: from scientific evidence generated in Colombia to worldwide practice. J Clin Epidemiol. 2017 Jun;86:125-128. doi: 10.1016/j.jclinepi.2016.05.019. Epub 2016 Oct 17.</citation>
    <PMID>27765653</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>July 25, 2019</last_update_submitted>
  <last_update_submitted_qc>July 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Skin-to-skin</keyword>
  <keyword>Kangaroo Care</keyword>
  <keyword>Kangaroo Mother Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Temperature Changes</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/NCT02998463
org study id: Bailey /Nov /2016 /RC /0640
nct id: NCT02998463
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the safety and efficacy of a skin-to-skin facilitating garment used by
      mother-infant dyads. It has three phases including researcher observation, randomised
      controlled trialing and qualitative midwifery staff perspective. The research will determine
      the effect a facilitating garment has in comparison to conventionally facilitated
      skin-to-skin contact, by measuring its effect on the baby's temperature stability,
      breastfeeding status and weight velocity.
Skin-to-skin contact is used as part of a package of Kangaroo Mother Care across the world.
      This has been demonstrated to reduce neonatal morbidity, mortality, and inpatient stays for
      low birth weight and preterm infants (Charpak and Ruiz 2016).

      This study examines the effect a facilitating garment, the Snuby® has on neonatal health
      outcomes associated with skin-to-skin contact, such as neonatal thermoregulation,
      breastfeeding status, and self-reported mother-infant bonding. It uses a mixed methods
      approach to address quantitative and qualitative outcomes including participant's
      perspectives, and measurable health markers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Abnormal neonatal temperature
time frame: Following 30 minutes of skin-to-skin contact, in both Intervention and Control groups.
description: Axillary temperature taken by the mother with Eco Temp Basic thermometer. Abnormal: less than 36.5°C or more than 37.5°C.
measure: Breastfeeding Status
time frame: Assessed at 3 days post birth, then weekly from day of birth until six weeks postnatal.
description: Exclusive breastfeeding, mixed breast and formula feeding, exclusive formula feeding, addition of expressed breastmilk. Includes a comparison to self reported antenatal infant feeding intentions.
measure: Mother Infant bonding
time frame: Six weeks post birth
description: Maternal participants will self report on their perspectives of skin-to-skin contact, and its role in the relationship bonding process between themselves and their babies.
measure: Neonatal Weight Velocity
time frame: At a minimum of 3 intervals, including at birth, ten days, and at six weeks post birth.
description: Neonatal weight in grams to ensure suitable for Snuby® garment.
measure: Maternal participant's perspective
time frame: Weekly until 6 weeks post birth
description: Maternal participants will self-report their views on the garment's ease of use and perceived value. This will be compared to the control group reporting on the same outcomes with conventionally facilitated skin-to-skin contact.
measure: Midwifery participant's perspective
time frame: 12 months post birth of the first participating mother-infant dyad.
description: Qualitative data collection from midwifery participants, including their perspectives on skin-to-skin contact in the hospital setting, and the perceived value of the Snuby® garment.
arm group label: Snuby® users
arm group type: Experimental
description: This group receives the Snuby® skin-to-skin facilitating garment to use in the first six weeks following birth with their baby. The use of the Snuby® garment is participant led, and used for as long and as often as they wish in the six week period.
arm group label: Conventional Care
arm group type: No Intervention
description: This group does not receive any intervention, and collects data on the research outcomes when having conventionally facilitated skin-to-skin contact, using a towel, blanket, or clothing as preferred. Skin-to-skin contact frequency and duration is dictated by the participant.
intervention type: Device
intervention name: skin-to-skin facilitating garment
description: Fabric garment designed to accommodate term neonates having skin-to-skin contact.
arm group label: Snuby® users
other name: Snuby®
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Helen McIntyre, DHSci
role: Principal Investigator
affiliation: University of Leicester
facility: 
facility: 
country: United Kingdom
citation: Charpak N, Ruiz JG. Latin American Clinical Epidemiology Network Series - Paper 9: The Kangaroo Mother Care Method: from scientific evidence generated in Colombia to worldwide practice. J Clin Epidemiol. 2017 Jun;86:125-128. doi: 10.1016/j.jclinepi.2016.05.019. Epub 2016 Oct 17.
PMID: 27765653
responsible party type: Sponsor
mesh term: Body Temperature Changes
sharing ipd: No