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Clinical Trials/ISRCTN15330120
ISRCTN15330120
Suspended
未知

Rethinking Strategies for Positive Newborn Screening Result (NBS+) Delivery (ReSPoND): A process evaluation of co-designing interventions to minimise impact on parental emotional well-being and stress

City, University of London0 sites160 target enrollmentJanuary 17, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
Genetic screening in newborn
Sponsor
City, University of London
Enrollment
160
Status
Suspended
Last Updated
3 years ago

Overview

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)

Registry
who.int
Start Date
January 17, 2018
End Date
December 31, 2020
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

  • 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

Outcomes

Primary Outcomes

Not specified

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