NCT07488520RecruitingPhase 4
Integrating Point of Care Testing (POCT) For Newborn Screening and Early Care for Sickle Cell Disease in Yopougon, Côte d'Ivoire
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 24 Feb 2026
- Start date
- 27 Jul 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Diseases
- Sickle cell disease
- NCT number
- NCT07488520
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 27 Jul 2026 to the primary completion date, 31 Dec 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Children already diagnosed with SCD
- Children that are participating in another clinical research project
- Children that are critically ill and require emergency treatment
Who the study is looking for
- Children aged 0 - 6 months old identified at selected health facilities within the study area
- Babies whose age plus the gestation period reaches 37 weeks or more
- Children who did not receive a blood transfusion within the past 90 days
- Children whose parents or guardians have consented to participate in the study by signing a consent form
Age in the registry: 0 months to 6 months · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yopougon Millionnaire extension health center Coordinator of this site? Confirm its status | Abidjan | Côte d’Ivoire | Recruiting |
| Yopougon SCD Center of Excellence Coordinator of this site? Confirm its status | Yopougon | Côte d’Ivoire | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.