Early Life Interventions for Sickle Cell Disease
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications, but you cannot participate if you are prescribed teratogenic medications (drugs that can cause birth defects).
Is early life intervention for sickle cell disease safe for humans?
The research does not provide specific safety data for early life interventions like breastfeeding support or observation for sickle cell disease, but it does mention that early standardized care, including vaccinations and preventive treatments, is being evaluated for its effectiveness in reducing mortality in children with sickle cell disease.12345
How does the treatment 'Observation' for sickle cell disease differ from other treatments?
Observation, also known as watchful waiting or active surveillance, is unique because it involves closely monitoring the patient's condition without immediate intervention, unlike other treatments that may involve medication or procedures. This approach allows for early detection of changes in the disease, potentially reducing acute events by ensuring timely care when necessary.46789
What is the purpose of this trial?
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.
Research Team
Brandi M Pernell, DNP, MSPH
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
This trial is for mothers of infants with sickle cell disease living near Birmingham, Alabama. They should have reliable internet access and not be on medications that can cause birth defects.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Mother-infant dyads are randomly assigned to a community-based breastfeeding support group or observation for 6 months
Observation
Observation of breastfeeding exclusivity/dosage and duration among mother-infant dyads
Follow-up
Participants are monitored for safety and effectiveness after intervention, including incidence of acute chest syndrome and asthma
Treatment Details
Interventions
- Breastfeeding support group
- Observation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor