Actively Recruiting
Early Life Exposures Among Children With Sickle Cell Disease
Led by University of Alabama at Birmingham · Updated on 2026-02-09
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the relationship between early childhood exposures, such as Adverse Childhood Experiences, Social Determinants of Health, and nutrition including breastfeeding, in children with sickle cell disease. The study aims to evaluate behavioral interventions that promote psychological resilience and positive lifestyle changes to improve health outcomes in these children. During the study, 20 mother-infant pairs will be randomly assigned to either a community-based breastfeeding support group or an observation group. The intervention group will participate in a six-month program that includes an online support group, educational modules, monthly in-person sessions, access to breast pump rentals, and monthly home visits by certified specialists. Blood samples will be collected at 3, 6, 12, and 24 months to measure inflammation and oxidative stress. The observation group will be followed for 24 months to monitor breastfeeding patterns and health outcomes. Participants will be assessed for enrollment acceptability, adherence to the intervention for at least six months, and preliminary effectiveness over two years. Researchers will monitor asthma development and episodes of acute chest syndrome over a four-year follow-up. The study includes regular evaluations through blood tests and health tracking to understand breastfeeding's impact on children with sickle cell disease and related health conditions.
CONDITIONS
Brief Title
Early Life Exposures Among Children With Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mother of an infant diagnosed with sickle cell disease
- Resides in or near Birmingham, Alabama
- Female aged 18 to 50 years
- Has internet access for online participation
You will not qualify if you...
- Taking prescribed teratogenic medications
- No or limited internet access
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or online)
Duration - 6 months
Participants in the intervention group join a community-based breastfeeding support group including online modules, monthly in-person sessions, peer-led home visits, and access to breast pump rentals for at least 6 months.
Monthly in-person educational sessions and monthly home visits
Duration - Up to 4 years
Participants are observed for breastfeeding exclusivity, duration, and child health outcomes including biomarkers of inflammation over 24 months, with additional health monitoring up to 4 years for asthma and acute chest syndrome development.
Blood specimen collections at 3, 6, 12, and 24 months; follow-up assessments during 4-year period
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
B
Brandi M Pernell, DNP, MSPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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