Early Life Exposures Among Children With Sickle Cell Disease

NCT ID: NCT05377372

Last Updated: 2025-05-06

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Sickle Cell Disease Adverse Childhood Experiences Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial
Primary Study Purpose

PREVENTION

Blinding Strategy

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.

Group Type EXPERIMENTAL

Breastfeeding support group

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Observation

Intervention Type OTHER

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

Intervention Type BEHAVIORAL

Observation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Brandi Pernell

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Central Contacts

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Brandi M Pernell, DNP, MSPH

Role: CONTACT

2058640238

Facility Contacts

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Brandi M Pernell, DNP, MSPH

Role: primary

2058640238

Other Identifiers

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IRB-300003639

Identifier Type: -

Identifier Source: org_study_id

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