Early-life exposures and breastfeeding in children with sickle cell disease
Early Life Exposures Among Children With Sickle Cell Disease
This project will try a community breastfeeding support group for mothers of infants with sickle cell disease to see if breastfeeding and related supports improve early-life exposures and child health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05377372 on ClinicalTrials.gov |
What this trial studies
This is a small randomized pilot in which 20 mother–infant pairs will be assigned to a community-based breastfeeding support group or to observation. The team will track acceptability of enrollment, adherence to the intervention for at least six months, and preliminary signals of effectiveness. Researchers will collect data on adverse childhood experiences, social determinants of health, and biomarkers of inflammation, and will compare development of asthma and the frequency of pain episodes and acute chest syndrome between groups. The intervention also includes behavioral components aimed at strengthening maternal psychological resilience and supportive lifestyle practices.
Who should consider this trial
Good fit: Mothers of infants diagnosed with sickle cell disease who live in or near Birmingham, Alabama and have reliable internet access are ideal candidates.
Not a fit: Families living outside the Birmingham area, those without reliable internet access, or children beyond the infant period are unlikely to benefit from this specific pilot intervention.
Why it matters
Potential benefit: If successful, the intervention could increase breastfeeding support and reduce inflammation and early respiratory and pain-related complications in infants with sickle cell disease.
How similar studies have performed: Breastfeeding support programs have improved breastfeeding rates in general populations, but using such programs to change inflammatory markers and clinical outcomes in infants with sickle cell disease is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Brandi M Pernell, DNP, MSPH — University of Alabama at Birmingham
- Study coordinator: Brandi M Pernell, DNP, MSPH
- Email: brandimcclain@uabmc.edu
- Phone: 2058640238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.