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Early Life Exposures Among Children With Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05377372
Recruitment Status : Recruiting
First Posted : May 17, 2022
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Brandi McClain, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Adverse Childhood Experiences Breastfeeding Behavioral: Breastfeeding support group Other: Observation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Life Exposures Among Children With Sickle Cell Disease
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: Breastfeeding Intervention Group Behavioral: Breastfeeding support group
community-based breastfeeding support group aimed to increase exclusive breastfeeding success rates among Black women

Placebo Comparator: Observation Group Other: Observation
Observe prospectively for breastfeeding initiation, duration and longitudinal health of child with sickle cell disease




Primary Outcome Measures :
  1. Feasibility [ 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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05377372


Contacts
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Contact: Brandi M Pernell, DNP 2058640238 brandimcclain@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Brandi M Pernell, DNP    205-864-0238    brandimcclain@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
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Responsible Party: Brandi McClain, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT05377372    
Other Study ID Numbers: IRB-300003639
First Posted: May 17, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brandi McClain, University of Alabama at Birmingham:
Sickle cell disease
Adverse Childhood Experiences
Resilience
Breastfeeding
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn