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Early Life Exposures Among Children With Sickle Cell Disease

Early Life Exposures Among Children With Sickle Cell Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05377372
Enrollment
20
Registered
2022-05-17
Start date
2026-08-01
Completion date
2027-12-31
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Childhood Experiences, Breastfeeding, Sickle Cell Disease

Keywords

Sickle cell disease, Adverse Childhood Experiences, Breastfeeding

Brief 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.

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

BEHAVIORALBreastfeeding support group

community-based breastfeeding support group aimed to increase exclusive breastfeeding success rates among Black women

OTHERObservation

Observe prospectively for breastfeeding initiation, duration and longitudinal health of child with sickle cell disease

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Randomized control trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptance and Retention of Mothers of Infants with Sickle Cell Disease to a Community-based Breastfeeding Intervention6 monthsacceptance (number of mothers enrolled/number of mothers approached) and retention (number of mothers to complete 6 month support group intervention/number enrolled)
Preliminary Effectiveness2 yearsPercentage of mothers of infants with sickle cell disease that successful complete 6 months of breastfeeding, comparing the intervention vs. control groups

Secondary

MeasureTime frameDescription
Asthma4 year follow up periodPrevalence of asthma among children with sickle cell disease that were breastfed compared to those that were not
Acute chest syndrome4 year follow up periodIncidence rate of episodes of acute chest syndrome among children with sickle cell disease that were vs. were not breastfed

Countries

United States

Contacts

CONTACTBrandi M Pernell, DNP, MSPH
brandimcclain@uabmc.edu2058640238
PRINCIPAL_INVESTIGATORBrandi M Pernell, DNP, MSPH

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026