Early Life Exposures Among Children With Sickle Cell Disease

The University of Alabama at Birmingham

Status: Not yet enrolling

Conditions: Breastfeeding; Sickle Cell Disease; Adverse Childhood Experiences

Treatments: Other: Observation; Behavioral: Breastfeeding support group

Study type: Interventional

Funder types: Other

Identifiers

NCT05377372

IRB-300003639

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Breastfeeding Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Breastfeeding support group

Observation Group

Other group

Description:

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.

Treatment:

Other: Observation