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Covid19COVID-BFNCT04476940

COVID-19 Breastfeeding Guideline for African-Americans

A study testing COVID-19 Breastfeeding Support in people with Covid19 and Exclusive Breastfeeding, run by Meharry Medical College at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Covid19, Exclusive Breastfeeding
What is being tested?
COVID-19 Breastfeeding Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
1 Sep 2020to 31 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Meharry Medical College

    Nashville, Tennessee, 37208

Other trials in United States

About this study

Official title: An Intervention to Promote COVID-19 Breastfeeding Guideline Adherence Among African American Mothers

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.

Read the detailed description

Phase 1: COVID-19 Breastfeeding Guideline Assessment Survey. 40 mothers who delivered during the period starting from January 1, 2020 to date will be recruited and consented to assess their exclusive breastfeeding (EBF) and COVID-19 breastfeeding patterns using a survey designed to be completed by interview on Zoom, phone, or any other social-distancing platform. Information to be collected in this survey will include: demography, medical history, COVID-19 status; COVID-19 breastfeeding guideline action; Stay-home pattern; Breastfeeding frequency and duration; Breastmilk expression frequency/duration; Frequency and volume of feeds with expressed breastmilk or formula.

Phase 2: Intervention Development:

Participating physicians will attend two 2-hour Zoom sessions, a 4-Module Online Breastfeeding Course, and a 1-hour orientation Zoom session in groups of not more than ten. The following presentations, course, surveys, other materials to be developed:

  1. . Three presentations: i). Introduction: Healthy People 2020 Breastfeeding Objectives, Tennessee breastfeeding statistics, Breastfeeding role of physicians, nurses, and certified lactation consultants (CLC). ii). Breastfeeding Challenges Faced by Mothers. iii). Obstetrician Breastfeeding Promotion Challenges.
  2. . Online Breastfeeding Promotion 101: A 10-hour course to be developed in partnership with Breastfeeding OUTLOOK, an online continuing education provider.
  3. . Research Tools: COVID-19 Breastfeeding Guideline Assessment surveys; Pre- and Post-Intervention surveys for physicians; Pre- and Post-Intervention surveys for patients; Consent forms for physicians; Consent and HIPAA forms for patients; Recruitment flyer and Breastfeeding brochure for patients.
  4. . Moderator Script for Community Engagement to guide the community-patient-provider stakeholder community advisory board (CAB) discussion sessions to review and make recommendations for revision to the following: intervention program, consent forms, surveys, brochure, COVID-19 related guidelines for pregnant and lactating mothers, and strategies to enhance participation. The 12-Person CAB of 4 mothers, 2 nurses/midwives, 2 CLCs, 2 physicians, a virologist, and a community leader. Investigator obstetrician Ladson, G. will be the moderator and the CAB recorder will be investigator Britt, A.

Phase 3: Program Implementation Feasibility and Evaluation:

20 Obstetricians/Physicians will be consented and enrolled to participate as program providers, and expected to complete the following 5 tasks:

  1. . Pre-Intervention Survey: This is 15-minute self-administered pre-test survey to capture breastfeeding promotion knowledge and practices, and COVID-19, other disease, and drug related breastfeeding guidelines.
  2. . First In-Person Session: 2-hour Zoom session in groups of not more than 10 participants to disseminate Program introduction (20 minutes); Breastfeeding challenges faced by mothers (40 minutes); Obstetrician breastfeeding promotion challenges (40 minutes); Closing session (20 minutes) for Concerns, Q \& A.
  3. . Online Breastfeeding Course 101: Participant physicians will enroll in Breastfeeding OUTLOOK and complete a 10-hour module over a two-week period.
  4. . Second In-Person Session: 2-hour Zoom session in groups of 10 to provide intervention guidelines, research strategies and skills for participant recruitment, consenting, and survey administration by interview.
  5. . Intervention Implementation: 20 physicians will each be expected to recruit 10 study participants in the third trimester of pregnancy from their prenatal clients over a period of two months. Physicians will complete a pre-intervention survey at enrollment and post-intervention survey 8 months after enrollment in the program. The physicians will receive intervention protocol, patient HIPPA \& consent forms, flyers, and survey booklet after signed consent received by email, and attend a one-hour program orientation in company of an office staff and/or resident physician scheduled in groups of four. The 200 study participants will sign informed consent, complete a pre-intervention patient survey, continue prenatal care, and will be followed up at 1-month and at 3-months postpartum to complete the post-intervention patient survey.

Study Questionnaires. i) Mother COVID-19 Breastfeeding Guideline Assessment Survey: Demography, medical history, items from Centers for Disease Prevention and Control (CDC) \& Baby-Friendly Hospital Initiative (BFHI) breastfeeding surveys, EBF pattern since January 1, 2020, COVID-19 guideline items, COVID-19 status, Stay-home history.

ii) Physician pre-intervention survey: Monthly prenatal volume, breastfeeding knowledge, and practices, CLC referral pattern, COVID-19 and other disease specific EBF guidelines.

iii) Physician post-intervention survey: Breastfeeding knowledge and practices, COVID-19 and other disease specific EBF guidelines. Number of participants enrolled and number of CLC referrals.

iv) Patient pre-intervention survey: Demography, medical history, CDC \& BFHI breastfeeding survey items, physician interaction items, previous CLC encounter, COVID-19 guideline items, COVID-19 status, Stay-home history.

  1. Patient post-intervention survey: CLC referral, CLC appointment and breastfeeding class attendance; COVID-19 guideline adherence; EBF initiation, frequency/duration of EBF; frequency and duration of breastmilk expression (manual or pump); frequency and volume of formula or breastmilk feeds. Infant feeding and growth pattern from medical records and growth charts. COVID-19 serology test (optional).
Being tested
COVID-19 Breastfeeding Support
Keywords
COVID-19, Exclusive Breastfeeding, Breastfeeding Guidelines, African American
Medical subject headings
COVID-19, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COVID-19 Breastfeeding SupportBehavioural

    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.

Study groups in NCT04476940
Study groupRoleWhat they receive
COVID BF-SupportExperimentalCOVID-19 breastfeeding guideline education and support for pregnant women.
Receives: Behavioral: COVID-19 Breastfeeding Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. COVID-19 breastfeeding guidance adherence at birth.

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

    Range: 0 to 100.

    Measured: At birth.

  2. COVID-19 breastfeeding guidance adherence at 1-month postpartum.

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

    Range: 0 to 100.

    Measured: At 1-month postpartum.

  3. COVID-19 breastfeeding guidance adherence at 3-months postpartum.

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

    Range: 0 to 100.

    Measured: At 3-months postpartum.

  4. Exclusive breastfeeding at birth.

    Percentage of participants who exclusively breastfed at birth. Range: 0 - 100.

    Measured: At birth.

  5. Exclusive breastfeeding at 1-month.

    Percentage of participants who exclusively breastfed at 1-month postpartum. Range: 0 - 100.

    Measured: At 1-month.

  6. Exclusive breastfeeding at 3-months.

    Percentage of participants who exclusively breastfed at 3-months postpartum. Range: 0 - 100.

    Measured: At 3-months.

Secondary outcomes (3)
  1. COVID_Status

    Infant COVID-19 test: Positive or Negative

    Measured: 3-months postpartum

  2. COVID-19 Immunoglobulin G

    Infant COVID-19 Immunoglobulin G serology test result.

    Measured: 3-months postpartum

  3. COVID-19 Immunoglobulin M

    Infant COVID-19 Immunoglobulin M serology test result.

    Measured: 3-months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2020
  2. Study start1 Sep 2020
  3. Primary completion31 Oct 2023 (estimated)
  4. Study completion31 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Pre-Test Post-test
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04476940
Sponsor's protocol ID
330875
Acronym
COVID-BF
Status last verified
Oct 2023
First submitted
13 Jul 2020
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing COVID-19 Breastfeeding Support in people with Covid19 and Exclusive Breastfeeding, run by Meharry Medical College at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COVID-19 breastfeeding guidance adherence at birth. (time frame: At birth.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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