Early Life Exposures Among Children With Sickle Cell Disease

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05377372
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 98.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 10, 2019
• Anticipated Primary Completion Date: Dec 31, 2027
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Feasibility [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Brandi McClain, Assistant Professor, University of Alabama at Birmingham: Sickle cell disease; Adverse Childhood Experiences; Resilience; Breastfeeding
• Additional relevant MeSH terms: Anemia, Sickle Cell

Study Results

No Results Posted as of May 17, 2022