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NCT05377372 Clinical Trial

Early Life Exposures Among Children With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:
Early Life Exposures Among Children With Sickle Cell Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05377372
Other study ID # IRB-300003639
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2025
Est. completion date December 31, 2027

Study information
Verified date August 2023
Source University of Alabama at Birmingham
Contact Brandi M Pernell, DNP, MSPH
Phone 2058640238
Email brandimcclain@uabmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Asthma Prevalence of asthma among children with sickle cell disease that were breastfed compared to those that were not 4 year follow up period
Secondary 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
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