Early Life Exposures Among Children With Sickle Cell Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breastfeeding support group, Observation.
- Who it may be relevant to
- Registry conditions: Sickle Cell Disease, Adverse Childhood Experiences, Breastfeeding. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
During year 3 of the award period, 20 mother-infant dyads will be randomly assigned to either a community-based breastfeeding support group or observation. Acceptability to enrollment, intervention adherence for at least 6 months and preliminary effectiveness will be captured. Biomarkers of inflammation, development of asthma and incidences of pain and/or acute chest syndrome will be compared among the intervention and control groups.
Interventions
- Behavioral Breastfeeding support group
community-based breastfeeding support group aimed to increase exclusive breastfeeding success rates among Black women - Other Observation
Observe prospectively for breastfeeding initiation, duration and longitudinal health of child with sickle cell disease
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Asthma [Time frame: 4 year follow up period]
- Acute chest syndrome [Time frame: 4 year follow up period]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT05377372 · IRB-300003639 · 5K23HL159280