<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/NCT03791749</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS: 252031</org_study_id>
    <nct_id>NCT03791749</nct_id>
  </id_info>
  <brief_title>Mother and Late Preterm Lactation Study</brief_title>
  <acronym>MAPLeS</acronym>
  <official_title>A Randomised Controlled Trial Testing the Use of a Simple Intervention on Maternal Psychological State, Breast Milk Composition and Volume, and Infant Behaviour and Growth.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</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>
      Breastfeeding has various benefits for the mother and infant. It has the capability of&#xD;
      reducing the risk of short term and long term problems for the infant, such as&#xD;
      gastroenteritis, respiratory infections, type II diabetes and obesity, and of providing&#xD;
      benefits for neurodevelopment. Breast milk offers even greater benefits for preterm infants.&#xD;
      Some of the advantages of breastfeeding are related to the constituents of breast milk such&#xD;
      as the macronutrients and bioactive factors, the hormones associated with breastfeeding such&#xD;
      as oxytocin, and the behavioural aspects of breastfeeding (maternal sensitivity to infant&#xD;
      cues). Despite these advantages, breastfeeding rates are below target levels mainly due to&#xD;
      the challenges that women face that hinder breastfeeding success. Interventions aimed at&#xD;
      improving policies, practices, and maternal support have been developed. However, other&#xD;
      interventions that target specific modifiable barriers to breastfeeding can be useful.&#xD;
&#xD;
      The aim of this study is to investigate a simple support intervention for breastfeeding&#xD;
      mothers of late preterm and early term infants on maternal stress reduction and infant weight&#xD;
      gain. The investigators also aim to study the potential mechanisms by which this effect could&#xD;
      be achieved (breast milk composition and volume, mother and infant behaviour).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Actual">March 13, 2021</completion_date>
  <primary_completion_date type="Actual">January 13, 2021</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal stress change at 6 weeks from 2 weeks post-delivery.</measure>
    <time_frame>Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)</time_frame>
    <description>Stress will be measured using the Perceived Stress Scale (0 to 40 points), where higher scores indicate a higher level of perceived stress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infant weight change at 6 weeks from 2 weeks post-delivery.</measure>
    <time_frame>Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)</time_frame>
    <description>Infant weight (kg) will be measured using an infant weighing scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Breast milk composition (macronutrients) change at 6 weeks from 2 weeks post-delivery.</measure>
    <time_frame>Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)</time_frame>
    <description>Breast milk samples will be collected at 2 and 6 weeks post-delivery. Fat, protein and carbohydrate content of breast milk (g/100 ml) will be analysed using the Miris- Human Milk Analyser.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast milk hormones change at 6 weeks from 2 weeks post-delivery.</measure>
    <time_frame>Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)</time_frame>
    <description>Breast milk samples will be collected at 2 and 6 weeks post-delivery. Ghrelin, leptin, adiponectin and cortisol will be analysed (ng/ml) using the respective ELISA kits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast milk volume change at 6 weeks from 2 weeks post-delivery.</measure>
    <time_frame>Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)</time_frame>
    <description>Breast milk volume (ml) will be assessed using 48-hour test weighing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant behaviour change at 6 weeks from 2 weeks post-delivery.</measure>
    <time_frame>Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)</time_frame>
    <description>Time spent crying and sleeping (minutes) will be measured using a 3-day behaviour diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant appetite change at 6 weeks from 2 weeks post-delivery.</measure>
    <time_frame>Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)</time_frame>
    <description>Infant appetite will be assessed using the Baby Eating Behaviour Questionnaire, with the following subscales (appetite traits): General Appetite (1 to 5 points), Enjoyment of Food (1 to 5 points), Satiety Responsiveness (1 to 5 points), Food Responsiveness (1 to 5 points), and Slowness in Eating (1 to 5 points). Higher scores on each subscale indicates a greater degree of the appetite trait.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mother-infant attachment change at 6 weeks from 2 weeks post-delivery.</measure>
    <time_frame>Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)</time_frame>
    <description>The extent of bonding between the mother and infant will be assessed using the Maternal Attachment Inventory (0-78 points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exclusive Breastfeeding Status</measure>
    <time_frame>6 weeks, 3 months and 6 months postnatally</time_frame>
    <description>Participants will be asked whether they are still exclusively breastfeeding their infants at 6 weeks, 3 months and 6 months postnatally to assess breastfeeding status.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Breastfeeding</condition>
  <condition>Postnatal Depression</condition>
  <condition>Stress, Psychological</condition>
  <condition>Preterm Infant</condition>
  <arm_group>
    <arm_group_label>Breastfeeding Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Home visits will be conducted at 2-3 and 6-8 weeks post-delivery. Mothers will be asked to perform a simple technique while breastfeeding at least once a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Home visits will be conducted at 2-3 and 6-8 weeks post-delivery. No intervention will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breastfeeding Support</intervention_name>
    <description>12-minute simple technique</description>
    <arm_group_label>Breastfeeding Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mothers of late preterm infants (34 to &lt;37 weeks) or early term infants (37 to 38&#xD;
             weeks)&#xD;
&#xD;
          -  Intending to breastfeed for at least 6 weeks&#xD;
&#xD;
          -  Free from serious illness&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently smoking or intending to smoke while breastfeeding&#xD;
&#xD;
          -  Not based in London&#xD;
&#xD;
          -  Prior breast surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breastfeeding</keyword>
  <keyword>postnatal mental health</keyword>
  <keyword>breastfeeding support</keyword>
  <keyword>stress</keyword>
  <keyword>late preterm infant</keyword>
  <keyword>breast milk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Stress, Psychological</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/NCT03791749
org study id: IRAS: 252031
nct id: NCT03791749
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Breastfeeding has various benefits for the mother and infant. It has the capability of
      reducing the risk of short term and long term problems for the infant, such as
      gastroenteritis, respiratory infections, type II diabetes and obesity, and of providing
      benefits for neurodevelopment. Breast milk offers even greater benefits for preterm infants.
      Some of the advantages of breastfeeding are related to the constituents of breast milk such
      as the macronutrients and bioactive factors, the hormones associated with breastfeeding such
      as oxytocin, and the behavioural aspects of breastfeeding (maternal sensitivity to infant
      cues). Despite these advantages, breastfeeding rates are below target levels mainly due to
      the challenges that women face that hinder breastfeeding success. Interventions aimed at
      improving policies, practices, and maternal support have been developed. However, other
      interventions that target specific modifiable barriers to breastfeeding can be useful.

      The aim of this study is to investigate a simple support intervention for breastfeeding
      mothers of late preterm and early term infants on maternal stress reduction and infant weight
      gain. The investigators also aim to study the potential mechanisms by which this effect could
      be achieved (breast milk composition and volume, mother and infant behaviour).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Maternal stress change at 6 weeks from 2 weeks post-delivery.
time frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
description: Stress will be measured using the Perceived Stress Scale (0 to 40 points), where higher scores indicate a higher level of perceived stress.
measure: Infant weight change at 6 weeks from 2 weeks post-delivery.
time frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
description: Infant weight (kg) will be measured using an infant weighing scale.
measure: Breast milk composition (macronutrients) change at 6 weeks from 2 weeks post-delivery.
time frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
description: Breast milk samples will be collected at 2 and 6 weeks post-delivery. Fat, protein and carbohydrate content of breast milk (g/100 ml) will be analysed using the Miris- Human Milk Analyser.
measure: Breast milk hormones change at 6 weeks from 2 weeks post-delivery.
time frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
description: Breast milk samples will be collected at 2 and 6 weeks post-delivery. Ghrelin, leptin, adiponectin and cortisol will be analysed (ng/ml) using the respective ELISA kits.
measure: Breast milk volume change at 6 weeks from 2 weeks post-delivery.
time frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
description: Breast milk volume (ml) will be assessed using 48-hour test weighing
measure: Infant behaviour change at 6 weeks from 2 weeks post-delivery.
time frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
description: Time spent crying and sleeping (minutes) will be measured using a 3-day behaviour diary
measure: Infant appetite change at 6 weeks from 2 weeks post-delivery.
time frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
description: Infant appetite will be assessed using the Baby Eating Behaviour Questionnaire, with the following subscales (appetite traits): General Appetite (1 to 5 points), Enjoyment of Food (1 to 5 points), Satiety Responsiveness (1 to 5 points), Food Responsiveness (1 to 5 points), and Slowness in Eating (1 to 5 points). Higher scores on each subscale indicates a greater degree of the appetite trait.
measure: Mother-infant attachment change at 6 weeks from 2 weeks post-delivery.
time frame: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)
description: The extent of bonding between the mother and infant will be assessed using the Maternal Attachment Inventory (0-78 points)
measure: Exclusive Breastfeeding Status
time frame: 6 weeks, 3 months and 6 months postnatally
description: Participants will be asked whether they are still exclusively breastfeeding their infants at 6 weeks, 3 months and 6 months postnatally to assess breastfeeding status.
arm group label: Breastfeeding Support
arm group type: Experimental
description: Home visits will be conducted at 2-3 and 6-8 weeks post-delivery. Mothers will be asked to perform a simple technique while breastfeeding at least once a day.
arm group label: Standard Care
arm group type: No Intervention
description: Home visits will be conducted at 2-3 and 6-8 weeks post-delivery. No intervention will be administered.
intervention type: Other
intervention name: Breastfeeding Support
description: 12-minute simple technique
arm group label: Breastfeeding Support
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Premature Birth
mesh term: Depression, Postpartum
mesh term: Stress, Psychological
sharing ipd: No