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A study working with healthcare professionals and parents/carers to explore whether giving information resources about medicines helps parents take their baby home from a neonatal unit

Parent co-Designed Drug Information for parents and Guardians Taking Neonates home (PADDINGToN 2) – a Feasibility Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66350435
Enrollment
75
Registered
2024-12-16
Start date
2024-10-01
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Whether giving information resources about medicines helps parents/carers take their baby home from a neonatal unit Pregnancy and Childbirth

Interventions

Current interventions as of 25/04/2025: The study will involve 3 work packages: Work Package A- The preparatory phase will start with establishing the resources on an electronic platform (vCreate),

Sponsors

Alder Hey Children's NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. PPAG - Parents/Carers whose baby has recently (ideally within 2 years but up to 5 years) been discharged from the neonatal unit and whose medication has been continued after discharge 2. WPB - Parents/Carers of babies receiving care on a neonatal unit who will require medication to be continued after discharge home from the hospital 3. WPC- Parents/Carers (10-15) and HCPs (10-15) who completed Work Package- B (WP-B) Feasibility 4. All WPs - Parents/Carers who do not speak any English will be eligible to take part in the interviews. Translation services will be provided to facilitate this 5. Community Parent Champions and community health care professionals 6. HCPS providing neonatal care in any of the four study sites or stakeholder groups from PADDINGToN1

Exclusion criteria

Exclusion criteria: 1. Parents/Carers whose baby’s medication is likely to stop before discharge 2. Parents/Carers whose baby has a terminal diagnosis of a severe congenital abnormality or critical illness (unlikely to survive) 3. Parents/Carers unwilling to have audio-visual recordings of focus groups/interviews 4. HCPs not providing care to neonates requiring medicines

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is to recruit 75 participants in 12 months and measure the attrition rate of participants who remain in the study until the end of the follow-up at 3 months

Secondary

MeasureTime frame
1. Parental anxiety, self-efficacy and confidence data measured using the GAD-7 questionnaire at baseline and 12 weeks and a short Likert scale at 1-2 weeks, 4-6 weeks, 8 weeks 2. Acceptability assessment of the intervention sub-group of participants measured using short interviews or questionnaires and Sekhon’s Theoretical Framework of Acceptability at the end of the study 3. Number of medication errors identified and relationship to parental confidence measures measured using a conversation with an HCP and demonstration of dose measurement at baseline and 4 weeks post-discharge 4. Healthcare utilisation by families following discharge measured using parent diaries throughout the 3-month study period

Countries

England, Northern Ireland, United Kingdom

Contacts

Public ContactLouise;Cara Bracken;Sutton

;

louise.bracken@alderhey.nhs.uk;cara.sutton@alderhey.nhs.uk+44 (0)151 252 5570;-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026