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Early Life Exposures Among Children With Sickle Cell Disease

Primary Purpose

Sickle Cell Disease, Adverse Childhood Experiences, Breastfeeding

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breastfeeding support group
Observation
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sickle Cell Disease focused on measuring Sickle cell disease, Adverse Childhood Experiences, Breastfeeding

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Breastfeeding Intervention Group

Observation Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
Preliminary Effectiveness
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

Asthma
Prevalence of asthma among children with sickle cell disease that were breastfed compared to those that were not
Acute chest syndrome
Incidence rate of episodes of acute chest syndrome among children with sickle cell disease that were vs. were not breastfed

Full Information

First Posted
May 11, 2022
Last Updated
August 4, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05377372
Brief Title
Early Life Exposures Among Children With Sickle Cell Disease
Official Title
Early Life Exposures Among Children With Sickle Cell Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2025 (Anticipated)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Adverse Childhood Experiences, Breastfeeding
Keywords
Sickle cell disease, Adverse Childhood Experiences, Breastfeeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breastfeeding Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Observation Group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Breastfeeding support group
Intervention Description
community-based breastfeeding support group aimed to increase exclusive breastfeeding success rates among Black women
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
Observe prospectively for breastfeeding initiation, duration and longitudinal health of child with sickle cell disease
Primary Outcome Measure Information:
Title
Acceptance and Retention of Mothers of Infants with Sickle Cell Disease to a Community-based Breastfeeding Intervention
Description
acceptance (number of mothers enrolled/number of mothers approached) and retention (number of mothers to complete 6 month support group intervention/number enrolled)
Time Frame
6 months
Title
Preliminary Effectiveness
Description
Percentage of mothers of infants with sickle cell disease that successful complete 6 months of breastfeeding, comparing the intervention vs. control groups
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Asthma
Description
Prevalence of asthma among children with sickle cell disease that were breastfed compared to those that were not
Time Frame
4 year follow up period
Title
Acute chest syndrome
Description
Incidence rate of episodes of acute chest syndrome among children with sickle cell disease that were vs. were not breastfed
Time Frame
4 year follow up period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandi M Pernell, DNP, MSPH
Phone
2058640238
Email
brandimcclain@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandi M Pernell, DNP, MSPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandi M Pernell, DNP, MSPH
Phone
205-864-0238
Email
brandimcclain@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
At the conclusion of this study, all individual participant data that underlie results in the original publication will be made available to other researchers for secondary analysis, replication of the study protocol, and expansion of this trial to additional sites.
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.

Learn more about this trial

Early Life Exposures Among Children With Sickle Cell Disease

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