COVID-19 Breastfeeding Guideline for African-Americans

NCT04476940 | Unknown

• 1 other identifier: 330875
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Exclusive Breastfeeding

Keywords

COVID-19; Exclusive Breastfeeding; Breastfeeding Guidelines; African American

Outcome Measures

Primary Outcomes (6)

• 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.

Secondary Outcomes (3)

• COVID_Status

  3-months postpartum

• COVID-19 Immunoglobulin G

  3-months postpartum

• COVID-19 Immunoglobulin M

  3-months postpartum

Other Outcomes (3)

• Certified Lactation Consult in pregnancy.

  At Birth.

• Certified Lactation Consult after delivery.

  At 1-month postpartum.

• COVID-19 breastfeeding guideline knowledge score change.

  1-month postpartum

Study Arms (1)

COVID BF-Support

EXPERIMENTAL

COVID-19 breastfeeding guideline education and support for pregnant women.

Behavioral: COVID-19 Breastfeeding Support

Interventions

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.

COVID BF-Support

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meharry Medical College: lead

Study Sites (1)

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

MeSH Terms

Conditions

COVID-19; Breast Feeding

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Feeding Behavior; Behavior

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-Test Post-test

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 20, 2020
• Study Start: September 1, 2020
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

US (1)