Covid19 Clinical Trial
— COVID-BFOfficial title:
An Intervention to Promote COVID-19 Breastfeeding Guideline Adherence Among African American Mothers
Verified date | October 2023 |
Source | Meharry Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 200 |
Est. completion date | October 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Meharry Medical College | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Meharry Medical College |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Certified Lactation Consult in pregnancy. | Percentage of patients who consulted a Certified Lactation Consultant before delivery.
Range: 0 - 100 |
At Birth. | |
Other | Certified Lactation Consult after delivery. | Percentage of patients who consulted a Certified Lactation Consultant up to 1-month postpartum.
Range: 0 - 100 |
At 1-month postpartum. | |
Other | 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 | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | Exclusive breastfeeding at birth. | Percentage of participants who exclusively breastfed at birth. Range: 0 - 100. | At birth. | |
Primary | Exclusive breastfeeding at 1-month. | Percentage of participants who exclusively breastfed at 1-month postpartum. Range: 0 - 100. | At 1-month. | |
Primary | Exclusive breastfeeding at 3-months. | Percentage of participants who exclusively breastfed at 3-months postpartum. Range: 0 - 100. | At 3-months. | |
Secondary | COVID_Status | Infant COVID-19 test: Positive or Negative | 3-months postpartum | |
Secondary | COVID-19 Immunoglobulin G | Infant COVID-19 Immunoglobulin G serology test result. | 3-months postpartum | |
Secondary | COVID-19 Immunoglobulin M | Infant COVID-19 Immunoglobulin M serology test result. | 3-months postpartum |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05047692 -
Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04395768 -
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19
|
Phase 2 | |
Terminated |
NCT04555096 -
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
|
Phase 2 | |
Completed |
NCT04506268 -
COVID-19 SAFE Enrollment
|
N/A | |
Completed |
NCT04508777 -
COVID SAFE: COVID-19 Screening Assessment for Exposure
|
||
Completed |
NCT04961541 -
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04546737 -
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
|
N/A | |
Completed |
NCT04494646 -
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
|
Phase 2 | |
Terminated |
NCT04542993 -
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
|
Phase 2 | |
Completed |
NCT04532294 -
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
|
Phase 1 | |
Terminated |
NCT04581915 -
PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT04543006 -
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
|
N/A | |
Not yet recruiting |
NCT04527211 -
Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel
|
Phase 3 | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
Completed |
NCT04387292 -
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
|
N/A | |
Not yet recruiting |
NCT05038449 -
Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19
|
N/A | |
Completed |
NCT04979858 -
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
|
N/A | |
Completed |
NCT04610502 -
Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients
|
Phase 2 | |
Active, not recruiting |
NCT06042855 -
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
|
Phase 3 |