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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.
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:
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:
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.
v) 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID BF-Support | Experimental | COVID-19 breastfeeding guideline education and support for pregnant women. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 Breastfeeding Support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At birth. |
| 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. | At 1-month postpartum. |
| 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. | At 3-months postpartum. |
| Exclusive breastfeeding at birth. | Percentage of participants who exclusively breastfed at birth. Range: 0 - 100. | At birth. |
| Exclusive breastfeeding at 1-month. | Percentage of participants who exclusively breastfed at 1-month postpartum. Range: 0 - 100. | At 1-month. |
| Exclusive breastfeeding at 3-months. | Percentage of participants who exclusively breastfed at 3-months postpartum. Range: 0 - 100. | At 3-months. |
| Measure | Description | Time Frame |
|---|---|---|
| COVID_Status | Infant COVID-19 test: Positive or Negative | 3-months postpartum |
| COVID-19 Immunoglobulin G | Infant COVID-19 Immunoglobulin G serology test result. |
| Measure | Description | Time Frame |
|---|---|---|
| Certified Lactation Consult in pregnancy. | Percentage of patients who consulted a Certified Lactation Consultant before delivery. Range: 0 - 100 | At Birth. |
| Certified Lactation Consult after delivery. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel E Adunyah, Ph.D. | Meharry Medical College | Study Director |
| Carlton Z Adams, M.D. | Meharry Medical College | Study Chair |
| Flora A Ukoli, M.D., MPH. | Meharry Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meharry Medical College | Nashville | Tennessee | 37208 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Pre-Test Post-test
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| 3-months postpartum |
| COVID-19 Immunoglobulin M | Infant COVID-19 Immunoglobulin M serology test result. | 3-months postpartum |
Percentage of patients who consulted a Certified Lactation Consultant up to 1-month postpartum.
Range: 0 - 100
| At 1-month postpartum. |
| COVID-19 breastfeeding guideline knowledge score change. | Change in pre- and post-intervention COVID-19 breastfeeding guideline knowledge score stratified to "Low" & "High". | 1-month postpartum |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |