Early Life Exposures Among Children With Sickle Cell Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Life Exposures Among Children With Sickle Cell Disease

Conditions
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Sickle Cell Disease, Adverse Childhood Experiences, Breastfeeding

Intervention / Treatment
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* Behavioral: Breastfeeding support group
* Other: Observation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breastfeeding Intervention Group<br>Ten mother-infant dyads will be recruited to a six-month, community-based intervention aimed to promote sustained breastfeeding for at least six months among mothers of infants with sickle cell disease. The intervention will include an online, social media-based support group, online educational modules, monthly in-person educational sessions, access to free breast pump rentals, and monthly peer-led home visits by certified Vanderbilt-affiliated Maternal Infant Health Outreach Specialists. We obtain whole blood specimens for analysis of oxidative stress and inflammation at 3, 6, 12 and 24 months. | Behavioral: Breastfeeding support group<br>* community-based breastfeeding support group aimed to increase exclusive breastfeeding success rates among Black women<br>|
| Other: Observation Group<br>A 24 month observation of 10 mother-infant dyads affected by sickle cell disease that initiate breastfeeding. These dyads will observed for breastfeeding exclusivity/dosage and duration. We obtain whole blood specimens for analysis of oxidative stress and inflammation at 3, 6, 12 and 24 months. | Other: Observation<br>* Observe prospectively for breastfeeding initiation, duration and longitudinal health of child with sickle cell disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 months | 
| Preliminary Effectiveness | Percentage of mothers of infants with sickle cell disease that successful complete 6 months of breastfeeding, comparing the intervention vs. control groups | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma | Prevalence of asthma among children with sickle cell disease that were breastfed compared to those that were not | 4 year follow up period | 
| Acute chest syndrome | Incidence rate of episodes of acute chest syndrome among children with sickle cell disease that were vs. were not breastfed | 4 year follow up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sickle cell disease, Adverse Childhood Experiences, Breastfeeding