The Experience of Screening for SCID
ConditionSevere Combined Immunodeficiency
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKing's College London
About this trial
This project will evaluate the impact of including Severe Combined Immunodeficiency into the newborn bloodspot screening panel. It will recruit parents and health professionals primarily from the sites where this new form of screening is being trialled well as additional sites where clinicians will be involved in the care of these babies and comparator groups are needed.
The proposed work will consist of two work packages. The first, a mixed-methods study conducted with families from the point of screening information being returned through to the child's fifth birthday. The second, a qualitative interview study conducted with health professionals during the clinical evaluation phase of the national pilot programme.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
1. Parent Study A) Parents whose baby was referred to an immunologist due their SCID screening result B) Parents who received a normal screening result C) False positives elsewhere in screening D) Parents who received a CFSPID result E) Parents whose baby was identified with SCID due to family history or clinical presentation F) Parents who have received an abnormal screening result (T cell receptor excision circles (TRECs) or who were identified with SCID due to family history or clinical presentation and whose baby has subsequently died 2. Health professional study Health professionals working in the evaluation centres will be invited to a semi-structured interview.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
SCID Screening
Other interventionThe addition of newborn bloodspot screening for severe combined immunodeficiency
Treatment groups
90 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Positive NBS for SCID1 intervention
Group B: Normal NBS result1 intervention
Group C: False positive NBS result0 interventions
Group D: CFSPID Designation0 interventions
Group E: SCID via family history or clinical presentation0 interventions
Group F: Parents whose babies have died1 intervention
Trial outcomes
Primary outcomes
1
EQ-5D-5L, GAD-7, ITQOL-47
Time frame
Every 12 months until the child is 5 years of age2
Qualitative interview data
Time frame
Jan 2022-Sept 2023Sponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College London
Lead sponsor
University of Manchester
Collaborator
University of Sheffield
Collaborator
Coventry University
Collaborator
National Health Service, United Kingdom
Collaborator
Source ClinicalTrials.gov