NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Integrating Point of Care Testing (POCT) For Newborn Screening and Early Care for Sickle Cell Disease in Yopougon, Côte d'Ivoire

NCT07488520

Not Yet RecruitingPhase 4

Sponsor: Swiss Tropical & Public Health Institute

Conditions: Sickle Cell Disease (SCD)

Interventions: Gazelle-Multispectral point of care testing for newborn sickle cell disease screening; and initiation of early comprehensive clinical interventions

Countries: Côte d’Ivoire

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 overview

Sex: ALL

Age: 0 Months to 6 Months

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Yopougon, Côte d’Ivoire