<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/NCT02201433</url>
  </required_header>
  <id_info>
    <org_study_id>PERAM-QUAL</org_study_id>
    <nct_id>NCT02201433</nct_id>
  </id_info>
  <brief_title>Study on the Treatment of Children and Their Families in Services Related to Early Childhood</brief_title>
  <acronym>PERAM-QUAL</acronym>
  <official_title>Study on the Treatment of Children and Their Families in Services Related to Early Childhood Morvan Hospital Qualitative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breastfeeding is recommended for preterm infants. Development of breastfeeding is an&#xD;
      important issue, requiring the involvement of medical and paramedical staff in neonatal&#xD;
      units. There are few data concerning the fathers of preterm infants. However, the role of the&#xD;
      father is identified in the literature as a key factor in the initiation and continuation of&#xD;
      breastfeeding. In our neonatal unit care, reasons for breastfeeding high rates are not&#xD;
      identified but may be related to the father being in close and constant contact with the&#xD;
      medical and paramedical staff. In fact, fathers are often first in contact with caregivers.&#xD;
      They can be invested in the implementation of nursing care, skin to skin, as well as being&#xD;
      asked to support the development of their child in the service and at home.&#xD;
&#xD;
      The aims of this study are to:&#xD;
&#xD;
        -  Analyze the beliefs, social representations and the experience of the fathers of&#xD;
           premature infants hospitalized in intensive care unit concerning breastfeeding.&#xD;
&#xD;
        -  Analyze the factors facilitating and inhibiting the initiation and continuation of&#xD;
           breastfeeding.&#xD;
&#xD;
        -  Consider strategies of care and support that can be used for the families of premature&#xD;
           infants and of children born at term.&#xD;
&#xD;
        -  Explore the expectations of medical staff with regards to the management of children and&#xD;
           families, their practices, identify the role attributed to the father.&#xD;
&#xD;
        -  Initiate and facilitate reflexivity of medical and paramedical staff about their&#xD;
           respective practices&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in three phases according to the methodology of qualitative&#xD;
      research:&#xD;
&#xD;
        -  The first for the preparation of interview guides and observation grids through the&#xD;
           inclusion of 20 participants: caregivers and members of associations of preterm parents,&#xD;
&#xD;
        -  The second part: maintenance by the inclusion of 40 fathers of children born preterm&#xD;
           before 37 weeks and their partner if she wants.&#xD;
&#xD;
        -  The third part will, as in any qualitative analysis, data validation with the inclusion&#xD;
           of 20 participants: fathers who experienced this situation in the context of care and&#xD;
           caregivers close to neonatal intensive unit care (NICU) are participants in the first&#xD;
           phase.&#xD;
&#xD;
      interview methods:&#xD;
&#xD;
        -  1 exploratory interview two hours on average with each part 1 and part 3 participants.&#xD;
&#xD;
        -  3-5 interviews per part 2 participant. Interviews are conduct with guideline constructed&#xD;
           during the first part of the study. Interview will be conducted by a nurse and /or a&#xD;
           psychologist&#xD;
&#xD;
      Data analysis:&#xD;
&#xD;
      Full transcript of the interviews. Partial treatment during the study to enrich the interview&#xD;
      guide until data saturation. All data will be treated differently: Software-aided thematic&#xD;
      treatment (NVivo) and textual processing with cross medical data and socio-demographic&#xD;
      variables (Alceste).&#xD;
&#xD;
      Data Validation :&#xD;
&#xD;
      Part 3 of the study external validation. Literature validation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">January 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Interviews</measure>
    <time_frame>Day 7</time_frame>
    <description>PERAM QUAL is a qualitative study, in accordance with the methodology of qualitative study, it is not possible to establish a quantitative criterion of judgment.&#xD;
Full transcript of the interviews should permit the identification of factors that promote breastfeeding.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">74</enrollment>
  <condition>Fathers</condition>
  <condition>Premature Birth</condition>
  <arm_group>
    <arm_group_label>medical staff and member of an association</arm_group_label>
    <description>members of medical staff and member of an association of parents of premature infants.&#xD;
This cohort is necessary to build protocol interview for part 2 of the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fathers</arm_group_label>
    <description>fathers of preterm newborns</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fathers or médical staff</arm_group_label>
    <description>This cohort is build for data validation. We will include fathers who have experienced this situation. Caregivers of NICU who are not participating in the first part</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Part 1: caregivers and members of associations of preterm parents Part 2: fathers of&#xD;
        preterm newborns, hospitalized in a neonatal intensive care unit Part 3: fathers who have&#xD;
        experienced premature and caregivers of NICU who not participating in the first part&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        PART 1&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Member of Association of Parents of premature children major (born before 37 weeks)&#xD;
&#xD;
          -  Medical staff (doctors, nurses, pediatric nurses, social worker, ...) working in the&#xD;
             NICU of the study.&#xD;
&#xD;
          -  Signing of free and informed consent&#xD;
&#xD;
        PART 2&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  major fathers of child born before 37 weeks who survived to the early neonatal period&#xD;
             (7days),&#xD;
&#xD;
          -  French mother tongue,&#xD;
&#xD;
          -  Residing in the geographical area of Brest&#xD;
&#xD;
          -  Signing of free and informed consent&#xD;
&#xD;
          -  Inclusion between Day 7 and Day 30 after the birth of their child&#xD;
&#xD;
        PART 3&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  fathers who have experienced child born premature&#xD;
&#xD;
          -  caregivers of NICU&#xD;
&#xD;
        PART 1, 2 and 3 exclusion criteria:&#xD;
&#xD;
          -  Person whose refuse to participate&#xD;
&#xD;
          -  Persons unable to consent&#xD;
&#xD;
          -  Persons whose monitoring is impossible&#xD;
&#xD;
          -  minor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HELENE DENOUAL</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Brest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH du Mans</name>
      <address>
        <city>Le Mans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>May 27, 2019</last_update_submitted>
  <last_update_submitted_qc>May 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breastfeeding</keyword>
  <keyword>fathers</keyword>
  <keyword>preterm newborns</keyword>
  <keyword>partner influence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <!-- 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/NCT02201433
org study id: PERAM-QUAL
nct id: NCT02201433
lead sponsor: 
has dmc: Yes
Breastfeeding is recommended for preterm infants. Development of breastfeeding is an
      important issue, requiring the involvement of medical and paramedical staff in neonatal
      units. There are few data concerning the fathers of preterm infants. However, the role of the
      father is identified in the literature as a key factor in the initiation and continuation of
      breastfeeding. In our neonatal unit care, reasons for breastfeeding high rates are not
      identified but may be related to the father being in close and constant contact with the
      medical and paramedical staff. In fact, fathers are often first in contact with caregivers.
      They can be invested in the implementation of nursing care, skin to skin, as well as being
      asked to support the development of their child in the service and at home.

      The aims of this study are to:

        -  Analyze the beliefs, social representations and the experience of the fathers of
           premature infants hospitalized in intensive care unit concerning breastfeeding.

        -  Analyze the factors facilitating and inhibiting the initiation and continuation of
           breastfeeding.

        -  Consider strategies of care and support that can be used for the families of premature
           infants and of children born at term.

        -  Explore the expectations of medical staff with regards to the management of children and
           families, their practices, identify the role attributed to the father.

        -  Initiate and facilitate reflexivity of medical and paramedical staff about their
           respective practices
The study will be conducted in three phases according to the methodology of qualitative
      research:

        -  The first for the preparation of interview guides and observation grids through the
           inclusion of 20 participants: caregivers and members of associations of preterm parents,

        -  The second part: maintenance by the inclusion of 40 fathers of children born preterm
           before 37 weeks and their partner if she wants.

        -  The third part will, as in any qualitative analysis, data validation with the inclusion
           of 20 participants: fathers who experienced this situation in the context of care and
           caregivers close to neonatal intensive unit care (NICU) are participants in the first
           phase.

      interview methods:

        -  1 exploratory interview two hours on average with each part 1 and part 3 participants.

        -  3-5 interviews per part 2 participant. Interviews are conduct with guideline constructed
           during the first part of the study. Interview will be conducted by a nurse and /or a
           psychologist

      Data analysis:

      Full transcript of the interviews. Partial treatment during the study to enrich the interview
      guide until data saturation. All data will be treated differently: Software-aided thematic
      treatment (NVivo) and textual processing with cross medical data and socio-demographic
      variables (Alceste).

      Data Validation :

      Part 3 of the study external validation. Literature validation
observational model: Cohort
time perspective: Prospective
measure: Interviews
time frame: Day 7
description: PERAM QUAL is a qualitative study, in accordance with the methodology of qualitative study, it is not possible to establish a quantitative criterion of judgment.
Full transcript of the interviews should permit the identification of factors that promote breastfeeding.
arm group label: medical staff and member of an association
description: members of medical staff and member of an association of parents of premature infants.
This cohort is necessary to build protocol interview for part 2 of the study
arm group label: fathers
description: fathers of preterm newborns
arm group label: fathers or médical staff
description: This cohort is build for data validation. We will include fathers who have experienced this situation. Caregivers of NICU who are not participating in the first part
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: HELENE DENOUAL
role: Principal Investigator
affiliation: University Hospital, Brest
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Premature Birth