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Early Life Interventions for Sickle Cell Disease

N/A

Waitlist Available

Led By Brandi M Pernell, DNP, MSPH

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mother of infant with sickle cell disease

Be between 18 and 65 years old

Must not have

Prescribed teratogenic medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 year follow up period

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if early intervention can improve health outcomes for children with sickle cell disease.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves non-medical support groups and observation, there are no direct medical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am taking medication that can harm a pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 year follow up period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 year follow up period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 year follow up period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptance and Retention of Mothers of Infants with Sickle Cell Disease to a Community-based Breastfeeding Intervention

Preliminary Effectiveness

Secondary study objectives

Acute chest syndrome

Asthma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Observation GroupExperimental Treatment1 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 GroupExperimental Treatment1 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.

0 / 2Eligibility criteria met