Early Life Exposures Among Children With Sickle Cell Disease
NCT ID: NCT05377372
Last Updated: 2025-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-09-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Breastfeeding Intervention Group
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.
Breastfeeding support group
community-based breastfeeding support group aimed to increase exclusive breastfeeding success rates among Black women
Observation Group
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.
Observation
Observe prospectively for breastfeeding initiation, duration and longitudinal health of child with sickle cell disease
Interventions
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Breastfeeding support group
community-based breastfeeding support group aimed to increase exclusive breastfeeding success rates among Black women
Observation
Observe prospectively for breastfeeding initiation, duration and longitudinal health of child with sickle cell disease
Eligibility Criteria
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Inclusion Criteria
* resides within the city of Birmingham, Alabama or in close proximity
Exclusion Criteria
* no/limited internet access
18 Years
50 Years
FEMALE
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Brandi Pernell
Assistant Professor
Principal Investigators
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Brandi M Pernell, DNP, MSPH
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-300003639
Identifier Type: -
Identifier Source: org_study_id
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