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.

Study Overview

• Status: Recruiting
• Conditions: Sickle Cell Disease; Breastfeeding; Adverse Childhood Experiences
• Intervention / Treatment: Behavioral: Breastfeeding support group; Other: Observation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brandi M Pernell, DNP, MSPH; Phone Number: 2058640238; Email: brandimcclain@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Brandi M Pernell, DNP, MSPH; Phone Number: 205-864-0238; Email: brandimcclain@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Breastfeeding support group; community-based breastfeeding support group aimed to increase exclusive breastfeeding success rates among Black women
Other: 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.	Other: Observation; Observe prospectively for breastfeeding initiation, duration and longitudinal health of child with sickle cell disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance and Retention of Mothers of Infants with Sickle Cell Disease to a Community-based Breastfeeding Intervention	acceptance (number of mothers enrolled/number of mothers approached) and retention (number of mothers to complete 6 month support group intervention/number enrolled)	6 months
Preliminary Effectiveness	Percentage of mothers of infants with sickle cell disease that successful complete 6 months of breastfeeding, comparing the intervention vs. control groups	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma	Prevalence of asthma among children with sickle cell disease that were breastfed compared to those that were not	4 year follow up period
Acute chest syndrome	Incidence rate of episodes of acute chest syndrome among children with sickle cell disease that were vs. were not breastfed	4 year follow up period

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Brandi M Pernell, DNP, MSPH, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Breastfeeding; Sickle cell disease; Adverse Childhood Experiences
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Hemic and Lymphatic Diseases; Feeding Behavior; Anemia, Sickle Cell; Breast Feeding; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: IRB-300003639; 5K23HL159280 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: I will share by IPD. I do not have a URL at this time and could not get my application to submit without submitting a URL
• IPD Sharing Time Frame: The results from this study will be published within 12 months of the study's completion. IPD will be made available after the results from this study have been published and will remain available for up to five years after the study's conclusion. Researches wishing to gain access to individual participant data should contact the Principal Investigator and sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No