Early Life Exposures Among Children With Sickle Cell Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Alabama at Birmingham
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
mother of infant with sickle cell disease
resides within the city of Birmingham, Alabama or in close proximity
Disqualifiers
prescribed teratogenic medications
no/limited internet access
Trial design
Design model
Parallel
Treatments tested in this trial
Breastfeeding support group
Behavioralcommunity-based breastfeeding support group aimed to increase exclusive breastfeeding success rates among Black women
Observation
Other interventionObserve prospectively for breastfeeding initiation, duration and longitudinal health of child with sickle cell disease
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Breastfeeding Intervention GroupExperimental treatment 1 intervention
Group B: Observation GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
Acceptance and Retention of Mothers of Infants with Sickle Cell Disease to a Community-based Breastfeeding Intervention
acceptance (number of mothers enrolled/number of mothers approached) and retention (number of mothers to complete 6 month support group intervention/number enrolled)
Time frame
6 months2
Preliminary Effectiveness
Percentage of mothers of infants with sickle cell disease that successful complete 6 months of breastfeeding, comparing the intervention vs. control groups
Time frame
2 yearsSecondary outcomes
1
Asthma
Prevalence of asthma among children with sickle cell disease that were breastfed compared to those that were not
Time frame
4 year follow up period2
Acute chest syndrome
Incidence rate of episodes of acute chest syndrome among children with sickle cell disease that were vs. were not breastfed
Time frame
4 year follow up periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov