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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adverse Childhood Experiences
• Anemia, Sickle Cell
• Breastfeeding
• Sickle Cell Disease

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