Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT05377372

Conditions

Sickle Cell Disease

Adverse Childhood Experiences

Breastfeeding

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Breastfeeding support group

Observation

Study Details

Brief summary:

This study is being conducted to determine the relationship between early childhood exposures, such as Adverse Childhood Experiences, Social Determinants of Health and nutrition/breastfeeding, among children with sickle cell disease, and behavioral interventions aimed to reshape psychological resilience and lifestyle factors towards positive health outcomes.

Conditions

Sickle Cell Disease

Adverse Childhood Experiences

Breastfeeding

Study ID

NCT05377372

Start date

Aug 1, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • mother of infant with sickle cell disease
  • resides within the city of Birmingham, Alabama or in close proximity

Exclusion Criteria:

  • prescribed teratogenic medications
  • no/limited internet access

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Breastfeeding Intervention Group

Ten mother-infant dyads will be recruited to a six-month, community-based intervention aimed to promote sustained breastfeeding for at least six months among mothers of infants with sickle cell disease. The intervention will include an online, social media-based support group, online educational modules, monthly in-person educational sessions, access to free breast pump rentals, and monthly peer-led home visits by certified Vanderbilt-affiliated Maternal Infant Health Outreach Specialists. We obtain whole blood specimens for analysis of oxidative stress and inflammation at 3, 6, 12 and 24 months.

other: Observation Group

A 24 month observation of 10 mother-infant dyads affected by sickle cell disease that initiate breastfeeding. These dyads will observed for breastfeeding exclusivity/dosage and duration. We obtain whole blood specimens for analysis of oxidative stress and inflammation at 3, 6, 12 and 24 months.

Interventions

Breastfeeding support group

community-based breastfeeding support group aimed to increase exclusive breastfeeding success rates among Black women

Observation

Observe prospectively for breastfeeding initiation, duration and longitudinal health of child with sickle cell disease

Primary outcome measure

  • Acceptance and Retention of Mothers of Infants with Sickle Cell Disease to a Community-based Breastfeeding Intervention [ Time Frame: 6 months ]
  • Preliminary Effectiveness [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Brandi M Pernell, DNP, MSPH

2058640238brandimcclain@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Brandi M Pernell, DNP, MSPH

2058640238brandimcclain@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • Sickle cell disease
  • Adverse Childhood Experiences
  • Breastfeeding

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-07-15.