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COVID-19 Breastfeeding Guideline for African-Americans (COVID-BF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04476940
Recruitment Status : Not yet recruiting
First Posted : July 20, 2020
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Meharry Medical College

Brief Summary:
Newborns and infants receive passive natural immunity through maternal antibodies present in breastmilk to fight infections caused by viruses such as the COVID-19, until they develop active immunity by illness or vaccination. Such immunity will become the main stay for preventing future waves of COVID-19 epidemics. The high COVID-19 mortality among African Americans is ascribed partly to compromised immune status associated with comorbidity. Exclusive breastfeeding (EBF) is the effective low-cost natural strategy for building immunity right from birth. African Americans record the lowest EBF rates and also lack workplace support. This intervention includes a 10-hour course extracted from 90-hour CLC online program, sufficient to prepare physicians to partner with certified lactation consultant (CLC) to provide their patients comprehensive COVID-19 breastfeeding guidelines, training, and support to afford their babies the benefits of breastmilk antibodies, the best line of defense against COVID-19, until availability of safe vaccines. The Breastfeeding Report Card indicates slow improvements in overall breastfeeding rates with persisting disparities. Improving EBF rates can contribute to increased COVID-19 immunity among infants. Preliminary data in Nashville indicates excellent breastfeeding benefit knowledge and intent, but limited training to succeed. Hospital staff encourage breastfeeding but routinely offer formula at birth. Most physicians who provide prenatal care do not actively promote breastfeeding nor routinely offer CLC referral. This single action by physicians can halt routines that compromise successful EBF. The program long-term goal is to prepare obstetricians to actively promote comprehensive breastfeeding among African American mothers. The immediate objective is to develop and evaluate feasibility and effectiveness of an intervention designed to increase COVID-19 breastfeeding guideline adherence and improve EBF skills and rates among African American mothers. The rationale is that mothers who receive physician prenatal encouragement and CLC referral will make confident informed decisions, adopt COVID-19 breastfeeding guidelines, safely meet their EBF goals, and provide their infants with appropriate antibodies. The expected outcome is that patient participants will adhere to COVID-19 breastfeeding guidelines and record 3-month EBF rate 60 percent or greater.

Condition or disease Intervention/treatment Phase
Covid19 Exclusive Breastfeeding Behavioral: COVID-19 Breastfeeding Support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pre-Test Post-test
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Intervention to Promote COVID-19 Breastfeeding Guideline Adherence Among African American Mothers
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COVID BF-Support
COVID-19 breastfeeding guideline education and support for pregnant women.
Behavioral: COVID-19 Breastfeeding Support
Intervention will be implemented by trained prenatal care providers to provide comprehensive exclusive breastfeeding and COVID-19 breastfeeding guideline education and support to study participants.




Primary Outcome Measures :
  1. COVID-19 breastfeeding guidance adherence at birth. [ Time Frame: At birth. ]

    Percentage of participants who recorded an adherence score of 4 and above during the first week of birth.

    Range: 0 to 100.


  2. COVID-19 breastfeeding guidance adherence at 1-month postpartum. [ Time Frame: At 1-month postpartum. ]

    Percentage of participants who recorded an adherence score of 4 and above at 1-month postpartum.

    Range: 0 to 100.


  3. COVID-19 breastfeeding guidance adherence at 3-months postpartum. [ Time Frame: At 3-months postpartum. ]

    Percentage of participants who recorded an adherence score of 4 and above at 3-months postpartum.

    Range: 0 to 100.


  4. Exclusive breastfeeding at birth. [ Time Frame: At birth. ]
    Percentage of participants who exclusively breastfed at birth. Range: 0 - 100.

  5. Exclusive breastfeeding at 1-month. [ Time Frame: At 1-month. ]
    Percentage of participants who exclusively breastfed at 1-month postpartum. Range: 0 - 100.

  6. Exclusive breastfeeding at 3-months. [ Time Frame: At 3-months. ]
    Percentage of participants who exclusively breastfed at 3-months postpartum. Range: 0 - 100.


Secondary Outcome Measures :
  1. COVID_Status [ Time Frame: 3-months postpartum ]
    Infant COVID-19 test: Positive or Negative

  2. COVID-19 Immunoglobulin G [ Time Frame: 3-months postpartum ]
    Infant COVID-19 Immunoglobulin G serology test result.

  3. COVID-19 Immunoglobulin M [ Time Frame: 3-months postpartum ]
    Infant COVID-19 Immunoglobulin M serology test result.


Other Outcome Measures:
  1. Certified Lactation Consult in pregnancy. [ Time Frame: At Birth. ]

    Percentage of patients who consulted a Certified Lactation Consultant before delivery.

    Range: 0 - 100


  2. Certified Lactation Consult after delivery. [ Time Frame: At 1-month postpartum. ]

    Percentage of patients who consulted a Certified Lactation Consultant up to 1-month postpartum.

    Range: 0 - 100


  3. COVID-19 breastfeeding guideline knowledge score change. [ Time Frame: 1-month postpartum ]
    Change in pre- and post-intervention COVID-19 breastfeeding guideline knowledge score stratified to "Low" & "High".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Assessment Survey: Mothers who had a baby in 2020.
  • Intervention Participants: Women in late 2nd or 3rd pregnancy trimester enrolled for prenatal care by participating physicians.

Exclusion Criteria:

  • Assessment Survey: Mothers who had a baby prior to 2020.
  • Intervention Participants: Not pregnant, in 1st trimester of pregnancy, not enrolled for prenatal care by participating physician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476940


Contacts
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Contact: Flora A Ukoli, M.D., MPH. 615-327-5653 fukoli@mmc.edu
Contact: Allysceaeioun D Britt, Ph.D., MPH. 615-327-6457 abritt@mmc.edu

Locations
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United States, Tennessee
Meharry Medical College
Nashville, Tennessee, United States, 37208
Contact: Flora A Ukoli, M.D., MPH.    615-327-5653    fukoli@mmc.edu   
Contact: Jacinat Leavell, Ph.D., MS    615-327-6885    jleavell@mmc.edu   
Sub-Investigator: Gwinett Ladson, M.D.         
Sub-Investigator: Kimberley Wyche-Etheridge, M.D.         
Sub-Investigator: Tao Lu, Ph.D.         
Sponsors and Collaborators
Meharry Medical College
Investigators
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Study Director: Samuel E Adunyah, Ph.D. Meharry Medical College
Study Chair: Carlton Z Adams, M.D. Meharry Medical College
Principal Investigator: Flora A Ukoli, M.D., MPH. Meharry Medical College
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Responsible Party: Meharry Medical College
ClinicalTrials.gov Identifier: NCT04476940    
Other Study ID Numbers: 330875
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meharry Medical College:
COVID-19
Exclusive Breastfeeding
Breastfeeding Guidelines
African American