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NCT Number: NCT05377372

Early Life Exposures Among Children With Sickle Cell Disease

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.

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Key information

Conditions

Sickle Cell Disease Adverse Childhood Experiences Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Behavior Breast Feeding Breastfeeding Congenital, Hereditary, and Neonatal Diseases and Abnormalities Feeding Behavior Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

Brandi M Pernell, DNP, MSPH

CONTACT

[email protected]

2058640238

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breastfeeding support group

Behavioral

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

observation

Other

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

Primary outcomes

  1. Acceptance and Retention of Mothers of Infants with Sickle Cell Disease to a Community-based Breastfeeding Intervention

    Time frame: 6 months

    acceptance (number of mothers enrolled/number of mothers approached) and retention (number of mothers to complete 6 month support group intervention/number enrolled)

  2. Preliminary Effectiveness

    Time frame: 2 years

    Percentage of mothers of infants with sickle cell disease that successful complete 6 months of breastfeeding, comparing the intervention vs. control groups

Secondary outcomes

  1. Asthma

    Time frame: 4 year follow up period

    Prevalence of asthma among children with sickle cell disease that were breastfed compared to those that were not

  2. Acute chest syndrome

    Time frame: 4 year follow up period

    Incidence rate of episodes of acute chest syndrome among children with sickle cell disease that were vs. were not breastfed

Study contacts

Contact information is provided by the study sponsor or research team.

Brandi M Pernell, DNP, MSPH

CONTACT

[email protected]

2058640238

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 17, 2022
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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