Rethinking Strategies for Positive Newborn Screening Result Delivery

Not Applicable

Suspended

• Conditions: Genetic screening in newborn; Genetic Diseases; Congenital Disorders

• Registration Number: ISRCTN15330120
• Lead Sponsor: City, University of London

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31508239 protocol (added 12/09/2019) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33004391/ Health professionals' experiences (added 07/10/2020) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34452966/ Process evaluation (added 01/09/2021) 2020 Interim results article in https://pubmed.ncbi.nlm.nih.gov/33310815/ Assessment of current practice (added 31/10/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35881727/ (added 31/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-17
• Study Completion: 2020-12-31
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Parents:
Parents of children who have received a NBS+ result in the previous 3-12 months including true positives, false positives and children who later have a cystic fibrosis screen positive, inconclusive diagnosis (CFSPID). This time frame has been chosen as the focus for this research based on feedback from parents of children who have previously received a NBS+ result. It has also been demonstrated that positive NBS can impact on child-parent relationships during the first year of life.

Health professionals:
1. Staff employed in NBS laboratories and involved in the processing of NBS+ results
2. Staff who have been involved in communicating NBS+ results to parents in the last 6 months.

Exclusion Criteria

Parents:
1. Parent of children who have received a negative NBS result
2. Parents of children with co-morbidities that are likely to influence their perception of receiving the positive NBS result
3. Parents whose baby has died prior to being approached to be involved in the study
4. Inability of parents to understand and give informed consent
5. Parents whose recruitment is contraindicated on psychosocial grounds (identified by their health visitor or specialist nurse)

Health professionals:
1. Staff who have not been involved in communicating positive NBS results to parents in the last 6 months
2. Staff who have personal experience of receiving a positive NBS result

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Production of co-designed, evaluated interventions for the communication of initial, positive NBS results to parent measured during the process evaluation and health economic analysis during months 18-27.