← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 year follow up period
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptance and Retention of Mothers of Infants with Sickle Cell Disease to a Community-based Breastfeeding Intervention
Preliminary Effectiveness
Secondary outcome measures
Acute chest syndrome
Asthma

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.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,565 Previous Clinical Trials
2,268,329 Total Patients Enrolled
Brandi M Pernell, DNP, MSPHPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Observation Clinical Trial Eligibility Overview. Trial Name: NCT05377372 — N/A
Sickle Cell Disease Research Study Groups: Breastfeeding Intervention Group, Observation Group
Sickle Cell Disease Clinical Trial 2023: Observation Highlights & Side Effects. Trial Name: NCT05377372 — N/A
Observation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05377372 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial include older adults aged 75 and over?

"This medical study requires that participants are between the ages of 18 to 50. However, there are 156 clinical trials available for minors and another 116 studies open to adults over 65 years old."

Answered by AI

Are there any available slots for participants in this research study?

"Affirmative, an analysis of clinicaltrials.gov verifies that this research is still recruiting patients. Starting October 10th 2019 and most recently updated on May 11th 2022, it's seeking 30 participants from one medical centre."

Answered by AI

How large is the current cohort engaging in this clinical experiment?

"Affirmative. The details hosted on clinicaltrials.gov demonstrate that this medical study, which initially appeared online 10/10/2019, is actively recruiting for 30 participants from one site."

Answered by AI

Does this study offer an opportunity for me to join in?

"This investigation is actively seeking 30 individuals with anemia or sickle cell between the ages of 18-50. Applicants must meet a few specific requirements to be considered, such as being a mother of an infant with SCD and residing in Birmingham, AL or its environs."

Answered by AI
~13 spots leftby Dec 2027