<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/NCT03013660</url>
  </required_header>
  <id_info>
    <org_study_id>IRB15-3993</org_study_id>
    <nct_id>NCT03013660</nct_id>
    <nct_alias>NCT02953795</nct_alias>
  </id_info>
  <brief_title>Supporting Mothers of Preterm Infants</brief_title>
  <official_title>Supporting Mothers of Preterm Infants: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tufts Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preterm birth is the leading contributor to mortality among children younger than 5 years.&#xD;
      One effective and inexpensive intervention is providing skin-to-skin care (STSC) whereby the&#xD;
      mother of a preterm baby provides skin-to-skin contact to the newborn for at least a few&#xD;
      hours, ideally every day. This intervention can make breastfeeding easier and can improve the&#xD;
      health and development of the baby.&#xD;
&#xD;
      Unfortunately, despite the large health benefits, mothers in low-resource communities are&#xD;
      often unable to practice STSC due to a range of institutional and economic barriers. STSC&#xD;
      requires substantial time and financial commitments from mothers; they must travel from home&#xD;
      each day to the hospital to engage in STSC and provide expressed breast milk. Low-income&#xD;
      women with access only to limited federally provided unpaid family leave may have to choose&#xD;
      between returning to work while their baby is in the NICU and being able to stay at home with&#xD;
      their newborn after discharge from the NICU. Families of preterm infants also face direct&#xD;
      financial costs of practicing STSC and breastfeeding (such as fees for parking and childcare&#xD;
      for older children).&#xD;
&#xD;
      This trial aims to examine the impact of providing additional support to low-income mothers&#xD;
      of babies born preterm in 2 hospitals in Massachusetts to help them provide STSC. Half of the&#xD;
      participants will be randomized to receive an additional financial support intervention while&#xD;
      their infant is in the NICU. The study will examine how this intervention impacts mothers'&#xD;
      health behavior while their child is in the NICU and up to three months after.&#xD;
&#xD;
      Most of the current and past policy efforts to increase STSC have focused on the delivery of&#xD;
      STSC at hospitals, focusing on supply-side related challenges such as the lack of trained and&#xD;
      informed staff. However, interventions that focus exclusively on hospitals are unlikely to be&#xD;
      sufficient for low-income women if there are significant opportunity costs or transportation&#xD;
      costs to simply being present at the hospital. This study aims to provide more evidence to&#xD;
      determine whether removing these financial barriers has the potential to mitigate the poor&#xD;
      outcomes of preterm babies born to lower socioeconomic status households.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">November 21, 2018</completion_date>
  <primary_completion_date type="Actual">July 5, 2018</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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of days mothers practice STSC</measure>
    <time_frame>Captured in hospital records during the first 1-3 weeks after enrollment</time_frame>
    <description>Number of days enrolled mothers practice STSC divided by the total number of days their infant is stable in the NICU (count starts after enrollment)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exclusive breastfeeding duration</measure>
    <time_frame>Self-reported after 3 months</time_frame>
    <description>Mean weeks of exclusive breastfeeding duration among enrolled mothers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in head circumference</measure>
    <time_frame>Head circumference measured at birth (time 0) and after 3 months</time_frame>
    <description>Difference between head circumference z-score at birth and at 3 months post-discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General infant development composite score (based on 5 age-appropriate milestones)</measure>
    <time_frame>Reported by mother at 3 month survey</time_frame>
    <description>Infant development composite score as measured by 5 age-appropriate motor, communication, and socioemotional milestones</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental/emotional wellbeing of mother</measure>
    <time_frame>Self-reported after 3 months</time_frame>
    <description>Mental/emotional wellbeing score of enrolled mothers based on Edinburgh Scale of Postpartum Depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mother-infant attachment</measure>
    <time_frame>Self-reported after 3 months</time_frame>
    <description>Attachment score between enrolled mothers and their preterm infant based on Postpartum Bonding Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmissions</measure>
    <time_frame>Self-reported after 3 months</time_frame>
    <description>Fraction of infants who were readmitted to the hospital post-discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost and cost-effectiveness</measure>
    <time_frame>Within 3 months of discharge</time_frame>
    <description>Total cost of infant's care, including both hospital and out-of-pocket spending</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any breastfeeding at 3mo</measure>
    <time_frame>Self-reported after 3 months</time_frame>
    <description>Fraction of mothers still breastfeeding (does not need to be exclusive) their infants at 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastfeeding initiation</measure>
    <time_frame>Captured in hospital records during first 1-3 weeks after enrollment</time_frame>
    <description>Fraction of mothers who ever begin breastfeeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of NICU stay</measure>
    <time_frame>Captured in hospital records during the first 1-3 weeks after enrollment</time_frame>
    <description>Number of days infants stay in the NICU before discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight-for-age z-score</measure>
    <time_frame>Change between measurement at birth (time 0) and after 3 months after discharge</time_frame>
    <description>Difference between birthweight z-score and weight-for-(corrected)-age z-score of infant at 3mo</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>PreTerm Birth</condition>
  <arm_group>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be provided with standard information about the benefits of STSC and breastfeeding and will be encouraged to come into the NICU every day for at least 1 hour of STSC. To facilitate increased let down of breast milk, all participants will be provided a hospital grade breast pump free of charge during the stay of their babies in the NICU and assistance will be provided to the mothers in procuring a Medicaid covered breast pump to keep when the baby leaves the NICU. The hospital grade breast pump will be provided to her as soon as she enrolls into the study and will remain with her until her baby is discharged or transferred.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment: Limited Financial Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to this arm will be contacted to be informed that they are eligible to receive a weekly financial transfer to help them spend more time with their baby at the NICU. The intervention participants will be eligible to receive this transfer every 7 days, starting on the day of enrollment. The participants selected for the intervention arm will be asked not to discuss the payment with any other study participants (such as the members of any other families they may see at the NICU) or other health care staff at the NICU. Participants will also receive everything that the Comparison group receives.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Limited Financial Support</intervention_name>
    <description>Subjects randomized to this arm will be contacted to be informed that they are eligible to receive a weekly financial transfer to help them spend more time with their baby at the NICU. The intervention participants will be eligible to receive this transfer every 7 days, starting on the day of enrollment.</description>
    <arm_group_label>Treatment: Limited Financial Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. mothers who gave (preterm) birth at the study hospitals as well mothers who gave birth&#xD;
             elsewhere (e.g. at a hospital without a high-level NICU) but whose babies were&#xD;
             immediately transferred to the study hospitals for preterm care after birth.&#xD;
&#xD;
          2. mothers of children born between 30 and 36 weeks of gestation without any major&#xD;
             complications requiring additional or special medical care for mother and child&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. under the age of 18 years&#xD;
&#xD;
          2. not currently covered by Medicaid&#xD;
&#xD;
          3. unable to speak or understand English or Spanish&#xD;
&#xD;
          4. not residents of the state of Massachusetts&#xD;
&#xD;
          5. any of the following complications: HIV infection, active tuberculosis, are undergoing&#xD;
             radiation therapy, recent breast surgery, indications of illicit drug use currently or&#xD;
             during pregnancy (from meconium or cord sample, or urine test), or other&#xD;
             contraindications for breastfeeding; or their baby has congenital, surgical, or&#xD;
             cardiac anomalies. Note that enrolled women who are identified as using illicit drugs&#xD;
             after enrollment will be removed from the study per hospital protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lowell General Hospital</name>
      <address>
        <city>Lowell</city>
        <state>Massachusetts</state>
        <zip>01854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 4, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03013660
org study id: IRB15-3993
nct id: NCT03013660
nct alias: NCT02953795
lead sponsor: 
collaborator: 
has dmc: No
Preterm birth is the leading contributor to mortality among children younger than 5 years.
      One effective and inexpensive intervention is providing skin-to-skin care (STSC) whereby the
      mother of a preterm baby provides skin-to-skin contact to the newborn for at least a few
      hours, ideally every day. This intervention can make breastfeeding easier and can improve the
      health and development of the baby.

      Unfortunately, despite the large health benefits, mothers in low-resource communities are
      often unable to practice STSC due to a range of institutional and economic barriers. STSC
      requires substantial time and financial commitments from mothers; they must travel from home
      each day to the hospital to engage in STSC and provide expressed breast milk. Low-income
      women with access only to limited federally provided unpaid family leave may have to choose
      between returning to work while their baby is in the NICU and being able to stay at home with
      their newborn after discharge from the NICU. Families of preterm infants also face direct
      financial costs of practicing STSC and breastfeeding (such as fees for parking and childcare
      for older children).

      This trial aims to examine the impact of providing additional support to low-income mothers
      of babies born preterm in 2 hospitals in Massachusetts to help them provide STSC. Half of the
      participants will be randomized to receive an additional financial support intervention while
      their infant is in the NICU. The study will examine how this intervention impacts mothers'
      health behavior while their child is in the NICU and up to three months after.

      Most of the current and past policy efforts to increase STSC have focused on the delivery of
      STSC at hospitals, focusing on supply-side related challenges such as the lack of trained and
      informed staff. However, interventions that focus exclusively on hospitals are unlikely to be
      sufficient for low-income women if there are significant opportunity costs or transportation
      costs to simply being present at the hospital. This study aims to provide more evidence to
      determine whether removing these financial barriers has the potential to mitigate the poor
      outcomes of preterm babies born to lower socioeconomic status households.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Care Provider)
measure: Proportion of days mothers practice STSC
time frame: Captured in hospital records during the first 1-3 weeks after enrollment
description: Number of days enrolled mothers practice STSC divided by the total number of days their infant is stable in the NICU (count starts after enrollment)
measure: Exclusive breastfeeding duration
time frame: Self-reported after 3 months
description: Mean weeks of exclusive breastfeeding duration among enrolled mothers
measure: Change in head circumference
time frame: Head circumference measured at birth (time 0) and after 3 months
description: Difference between head circumference z-score at birth and at 3 months post-discharge
measure: General infant development composite score (based on 5 age-appropriate milestones)
time frame: Reported by mother at 3 month survey
description: Infant development composite score as measured by 5 age-appropriate motor, communication, and socioemotional milestones
measure: Mental/emotional wellbeing of mother
time frame: Self-reported after 3 months
description: Mental/emotional wellbeing score of enrolled mothers based on Edinburgh Scale of Postpartum Depression
measure: Mother-infant attachment
time frame: Self-reported after 3 months
description: Attachment score between enrolled mothers and their preterm infant based on Postpartum Bonding Questionnaire
measure: Readmissions
time frame: Self-reported after 3 months
description: Fraction of infants who were readmitted to the hospital post-discharge
measure: Cost and cost-effectiveness
time frame: Within 3 months of discharge
description: Total cost of infant's care, including both hospital and out-of-pocket spending
measure: Any breastfeeding at 3mo
time frame: Self-reported after 3 months
description: Fraction of mothers still breastfeeding (does not need to be exclusive) their infants at 3 months
measure: Breastfeeding initiation
time frame: Captured in hospital records during first 1-3 weeks after enrollment
description: Fraction of mothers who ever begin breastfeeding
measure: Duration of NICU stay
time frame: Captured in hospital records during the first 1-3 weeks after enrollment
description: Number of days infants stay in the NICU before discharge
measure: Change in weight-for-age z-score
time frame: Change between measurement at birth (time 0) and after 3 months after discharge
description: Difference between birthweight z-score and weight-for-(corrected)-age z-score of infant at 3mo
arm group label: Comparison
arm group type: No Intervention
description: Participants will be provided with standard information about the benefits of STSC and breastfeeding and will be encouraged to come into the NICU every day for at least 1 hour of STSC. To facilitate increased let down of breast milk, all participants will be provided a hospital grade breast pump free of charge during the stay of their babies in the NICU and assistance will be provided to the mothers in procuring a Medicaid covered breast pump to keep when the baby leaves the NICU. The hospital grade breast pump will be provided to her as soon as she enrolls into the study and will remain with her until her baby is discharged or transferred.
arm group label: Treatment: Limited Financial Support
arm group type: Experimental
description: Subjects randomized to this arm will be contacted to be informed that they are eligible to receive a weekly financial transfer to help them spend more time with their baby at the NICU. The intervention participants will be eligible to receive this transfer every 7 days, starting on the day of enrollment. The participants selected for the intervention arm will be asked not to discuss the payment with any other study participants (such as the members of any other families they may see at the NICU) or other health care staff at the NICU. Participants will also receive everything that the Comparison group receives.
intervention type: Other
intervention name: Limited Financial Support
description: Subjects randomized to this arm will be contacted to be informed that they are eligible to receive a weekly financial transfer to help them spend more time with their baby at the NICU. The intervention participants will be eligible to receive this transfer every 7 days, starting on the day of enrollment.
arm group label: Treatment: Limited Financial Support
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Premature Birth
sharing ipd: No