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.
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
Children already diagnosed with SCD
Children that are participating in another clinical research project
Children that are critically ill and require emergency treatment
Swiss Tropical & Public Health Institute
Lead sponsor
Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Collaborator
Novartis Pharma AG, Switzerland
Collaborator