NCT07488520 Integrating Point of Care Testing (POCT) For Newborn Screening and Early Care for Sickle Cell Disease in Yopougon, Côte d'Ivoire
| NCT ID | NCT07488520 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Swiss Tropical & Public Health Institute |
| Condition | Sickle Cell Disease (SCD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-07-27 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2026-07-27 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if a multifaceted intervention composed of Gazelle-Multispectral sickle cell disease (SCD) point of care testing (POCT) and early initiation of comprehensive SCD care in children with SCD disease aged 0 - 6 months can improve their clinical outcomes. The main questions it aims to answer are: * Does the intervention lower the number of SCD-related illnesses? * Does the intervention lower the illness incidence defined as seeking health care at any health facility - with or without treatment - for any episode related to a SCD related illness? * Does the intervention lower all-cause death rate (at the end of 1, 2, 3 and 3.5 years of follow-up)? Researchers will compare the multifaceted intervention results with those of historical data (based on erratic SCD testing and treatment) from the region. Participants will undergo a SCD screening test using the Gazelle Multispectral platform and if positive they will undergo confirmatory testing with HemoTypeSC™. Participants with SCD will receive early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea, parental education about the need for regular and, if necessary, urgent medical care.
Eligibility Criteria
Inclusion Criteria: 1. Children aged 0 - 6 months old identified at selected health facilities within the study area 2. Babies whose age plus the gestation period reaches 37 weeks or more 3. Children who did not receive a blood transfusion within the past 90 days 4. Children whose parents or guardians have consented to participate in the study by signing a consent form Exclusion Criteria: 1. Children already diagnosed with SCD 2. Children that are participating in another clinical research project 3. Children that are critically ill and require emergency treatment
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07488520 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 6 Months, studying Sickle Cell Disease (SCD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07488520 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07488520 currently recruiting?
Yes, NCT07488520 is actively recruiting participants. Contact the research team at charles.abongomera@swisstph.ch for enrollment information.
Where is the NCT07488520 trial being conducted?
This trial is being conducted at Abidjan, Côte d’Ivoire, Yopougon, Côte d’Ivoire.
Who is sponsoring the NCT07488520 clinical trial?
NCT07488520 is sponsored by Swiss Tropical & Public Health Institute. The trial plans to enroll 120 participants.
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