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PADDINGToN - a study working with healthcare professionals and parents/carers to co-design resources for use in the UK and Ireland, aimed at improving medication safety for those giving medications to neonates in the home environment.

Parent Co-designed Drug Information for Parents and Guardians taking Neonates Home

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN17332620
Enrollment
185
Registered
2021-06-10
Start date
2021-06-01
Completion date
Unknown
Last updated
2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication safety for those giving medications to neonates in the home environment Not Applicable

Interventions

Work package 1 - Project management and coordination: including oversight of Study Management Group (SMG) and Research Delivery Group (RDG), protocol development, regulatory approvals (REC, HRA), site

Sponsors

Alder Hey Children's NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Parents/Carers (focus groups, co-designing resources, evaluation of resources): 1. Parents/Carers of babies receiving care on a neonatal unit in one of the 5 study sites who will require medication to be continued after discharge from hospital 2. Parents/Carers whose baby has recently been discharged from the neonatal unit at one of the 5 study sites and whose medication has continued after discharge 3. Arrangements will be made for Parents/Carers who do not have access to a smart phone or the internet to be able to contribute (eg face to face focus group may be offered where possible or phone credit will be provided) Health Care Professionals 4. Nurses, doctors, ANNPs or pharmacy staff providing neonatal care in any of the five study sites 5. Other HCPs identified from the staff stakeholder map identified in 7.2.1 (eg NPPG, Irish Neonatal Health Alliance) Neonatal parent support groups 6. Parents/Carers of babies who required medicines following discharge and are part of a neonatal parent support group identified in 7.2.1 (eg BLISS) 7. Parents/Carers of neonates whose babies were discharged from hospital within the last 5 years

Exclusion criteria

Exclusion criteria: Parents/Carers 1. Parents/Carers who do not speak English (the resources will initially be developed in English and then we will apply for further funding to allow them to be translated into other languages) 2. Parents/Carers whose baby’s medication is likely to stop prior to discharge 3. Parents/Carers whose baby has a terminal diagnosis, a severe congenital abnormality or critical illness (unlikely to survive). 4. Parents/Carers unwilling to have audio-visual recording of focus group/interviews 5. Parents/Carers less than 16 years of age (the resources will initially be developed for parents/carers able to consent themselves, however, once the co-designed resources are available, we would like to explore utility in this group of parents) Health Care Professionals 6. HCPs not providing care to neonates requiring medicines

Design outcomes

Primary

MeasureTime frame
1. Qualitative assessment of the usability and accessibility of resources available for parents/cares and healthcare professionals measured using e-surveys in July and focus groups in August 2021 2. Quantitative assessment of efficacy of the co-designed resources measured using a questionnaire circulated to a small group of HCPs to obtain feedback on training and support required to implement the resources Jan/Feb 2022 3. Ease of implementation – a questionnaire will be circulated to a small group of HCPs to obtain feedback on training and support required to implement the resources Jan/Feb 2022 4. An evaluation of the resource with a new group of parents/carers (approximately 10-15) to estimate: a. Utility - qualitative exploration (short semi-structured interviews) of usability, accessibility, language, detail, size, complexity, etc. b. Initial efficacy – Quantitative evaluation of knowledge acquisition Jan/Feb 2022

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

England, Ireland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026