Early Life Interventions for Sickle Cell Disease

Overseen By Brandi M Pernell, DNP, MSPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Teratogenic medications

Disqualifiers: No internet access, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how early life experiences and breastfeeding affect the health of children with sickle cell disease. Researchers aim to determine if promoting breastfeeding can enhance psychological resilience and lead to better health outcomes. The trial includes two groups: one group will receive support to encourage breastfeeding, while the other will be observed (also known as observation or watchful waiting). Mothers of infants with sickle cell disease living near Birmingham, Alabama, who have internet access, may be suitable for this study. As an unphased trial, this study provides a unique opportunity to understand how breastfeeding might improve health outcomes for children with sickle cell disease.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but you cannot participate if you are prescribed teratogenic medications (drugs that can cause birth defects).

What prior data suggests that these interventions are safe for children with sickle cell disease?

Research shows that breastfeeding offers many health benefits for both mothers and babies. One study found that women who do not breastfeed are twice as likely to experience postpartum relapse compared to those who do. Although this study does not specifically address sickle cell disease, it highlights the overall benefits and safety of breastfeeding.

This trial focuses on supporting breastfeeding mothers of babies with sickle cell disease. While specific safety data for this type of support is lacking, breastfeeding is generally considered safe and beneficial.

The trial will observe a group by tracking breastfeeding habits and collecting blood samples to study stress and inflammation. This standard practice does not involve any new or risky treatments.

Overall, these activities appear safe and promote breastfeeding, which is known to have positive health effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of sustained breastfeeding as an early life intervention for infants with sickle cell disease. Unlike traditional treatments that often focus on managing symptoms through medication and blood transfusions, this approach emphasizes natural maternal support to potentially reduce oxidative stress and inflammation in infants. By integrating community resources such as online support and educational modules, this trial aims to discover whether promoting breastfeeding can offer additional health benefits and improve long-term outcomes for children with sickle cell disease.

What evidence suggests that this trial's treatments could be effective for sickle cell disease?

This trial will compare a breastfeeding intervention with an observation approach for infants with sickle cell disease (SCD). Research has shown that breastfeeding may protect children with SCD. Studies have found that breastfeeding can reduce stress and swelling, common issues in SCD. It also supplies essential nutrients and immune support, enhancing overall health. This is crucial for babies with SCD, as early nutrition is vital. Although more research is needed, early findings suggest that encouraging breastfeeding could strengthen children and improve health outcomes for those with this condition. ^{1 2 3 4 6}

Who Is on the Research Team?

Brandi M Pernell, DNP, MSPH

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for mothers of infants with sickle cell disease living near Birmingham, Alabama. They should have reliable internet access and not be on medications that can cause birth defects.

Inclusion Criteria

I am the mother of a baby with sickle cell disease.

Resides within the city of Birmingham, Alabama or in close proximity

Exclusion Criteria

I am taking medication that can harm a pregnancy.

No/limited internet access

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Mother-infant dyads are randomly assigned to a community-based breastfeeding support group or observation for 6 months

6 months

Monthly in-person educational sessions, monthly peer-led home visits

Observation

Observation of breastfeeding exclusivity/dosage and duration among mother-infant dyads

24 months

Blood specimens collected at 3, 6, 12, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after intervention, including incidence of acute chest syndrome and asthma

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Breastfeeding support group
• Observation

Trial Overview The study looks at how early life experiences affect children with sickle cell disease. It includes a breastfeeding support group to see if it helps build resilience and improve health outcomes.

How Is the Trial Designed?

Group I: Observation Group Experimental Treatment 1 Intervention

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.

Group II: Breastfeeding Intervention Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11141211

Project Details - NIH RePORTER The long-term goal for this research is to establish the protective benefits of breastfeeding in SCD and improve overall health outcomes through the promotion ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10343612/

Knowledge Gaps and Current Evidence Regarding ... This review aimed at summarizing the available research literature regarding breastfeeding in mothers with chronic diseases.

3. withpower.com withpower.com/trial/early-life-interventions-for-sickle-cell-disease-7b923

Early Life Interventions for Sickle Cell Disease The study looks at how early life experiences affect children with sickle cell disease. It includes a breastfeeding support group to see if it helps build ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02140554

A Study Evaluating the Safety and Efficacy of Lovo-cel in ... This is a non-randomized, open label, multi-site, single dose, Phase 1/2 study in approximately 50 adults and adolescents with severe SCD.

5. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/abs/10.1002/phar.2793

Hydroxyurea treatment for sickle cell anemia during ... Hydroxyurea is currently contraindicated for pregnant and lactating women with SCA. Clinical experience of hydroxyurea use during pregnancy is increasingly ...

6. ashpublications.org ashpublications.org/bloodadvances/article/8/16/4359/516829/Prophylactic-exchange-transfusion-in-sickle-cell

Prophylactic exchange transfusion in sickle cell disease ... A trend toward a lower incidence of vaso-occlusive crisis, preterm delivery, and improved birthweight was observed in the intervention. The ...