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

20 Participants Needed

Trial Summary

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).

Is early life intervention for sickle cell disease safe for humans?

The research does not provide specific safety data for early life interventions like breastfeeding support or observation for sickle cell disease, but it does mention that early standardized care, including vaccinations and preventive treatments, is being evaluated for its effectiveness in reducing mortality in children with sickle cell disease. ^{1 2 3 4 5}

How does the treatment 'Observation' for sickle cell disease differ from other treatments?

Observation, also known as watchful waiting or active surveillance, is unique because it involves closely monitoring the patient's condition without immediate intervention, unlike other treatments that may involve medication or procedures. This approach allows for early detection of changes in the disease, potentially reducing acute events by ensuring timely care when necessary. ^{4 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Brandi M Pernell, DNP, MSPH

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Survival of children with sickle cell disease. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The Consortium on Newborn Screening in Africa for sickle cell disease: study rationale and methodology. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Clinical outcomes in children with sickle cell disease living in England: a neonatal cohort in East London. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Newborn screening follow-up within the lifespan context: Michigan's experience. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of newborn sickle cell screening programme in England: 2010-2016. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The risk of acute events among patients with sickle cell disease in relation to early or late initiation of care at a specialist center: evidence from a retrospective cohort study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Improved survival in homozygous sickle cell disease: lessons from a cohort study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Structured telephone-based outreach using nonmedical personnel can improve adherence to comprehensive care in families of children with sickle cell disease. [2007]

9. Spain pubmed.ncbi.nlm.nih.gov

[Primary care follow-up of newborns with sickle cell disease detected in neonatal screening in the Community of Madrid]. [2017]