Evaluating the impact of newborn screening for Severe Combined Immunodeficiency
Exploring Parents' and Health Professionals' Experiences of Screening for Severe Combined Immunodeficiency
This study is testing whether adding Severe Combined Immunodeficiency (SCID) screening to newborn blood tests can help families and doctors understand its impact on children's health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05651113 on ClinicalTrials.gov |
What this trial studies
This project assesses the effects of including Severe Combined Immunodeficiency (SCID) in the newborn bloodspot screening panel. It will involve parents and health professionals from various sites where this screening is being implemented, as well as additional sites for comparative analysis. The study consists of two main components: a mixed-methods study tracking families from screening to the child's fifth birthday, and qualitative interviews with health professionals during the clinical evaluation phase of the national pilot program. The evaluation aims to address uncertainties regarding the introduction of SCID screening in the UK.
Who should consider this trial
Good fit: Ideal candidates for this study are parents of newborns who are being screened for SCID as part of the newborn bloodspot screening program.
Not a fit: Patients who may not benefit include those whose newborns are not part of the screening program or who do not have SCID.
Why it matters
Potential benefit: If successful, this could lead to earlier detection and management of SCID in newborns, improving health outcomes.
How similar studies have performed: Other studies have shown success with similar newborn screening approaches, suggesting potential for effective implementation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants must be at least 18 years of age. Participants must be able to understand the purpose and implications of the research study. Where participants are speakers of languages other than English, the research team will arrange a translator. Exclusion Criteria: Where a child dies after recruitment to the project the team will sensitively check whether the parents wish to continue participation to enable their views to be included.
Where this trial is running
London
- King's College London — London, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.