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Development and feasibility study of an evidence-informed manualised intervention to compare CUe-Based versus Scheduled feeding for preterm infants transitioning from tube to oral feeding in neonatal units (CuBS)

Development and feasibility study of an evidence-informed manualised intervention to compare CUe-Based versus Scheduled feeding for preterm infants transitioning from tube to oral feeding in neonatal units (CuBS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13414304
Enrollment
165
Registered
2018-06-22
Start date
2018-07-01
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Feeding of preterm babies in neonatal units Nutritional, Metabolic, Endocrine

Interventions

1. Work Package 1: Participants (parents and staff) recruited to this phase of the study will participate in either one focus group or one interview lasting about 1 hour. There will be no follow-up. T
and conduct qualitative research to explore parents’ and staff’s understanding and attitudes to cue-based feeding. 2. Work Package 3: Participants (babies and their parents) will be re

Sponsors

NHS Tayside
Lead Sponsor
University Of Dundee
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Neonates: 1. Developmentally normal 2. Born before 37 weeks gestation 3. Clinically stable 4. At least partially enterally fed, with an intragastric tube in place at the start of the study 5. Parent(s) consent to inclusion in the study Parents of infants meeting the above criteria Healthcare staff: 1. Multi-disciplinary healthcare staff working in neonatal units, including medical consultants, registrars and junior doctors, neonatal nurses, advanced neonatal nurse practitioners, nurse managers and nursery nurses, speech and language therapists, and dieticians. 2. For the telephone interviews in WP1c, the target population includes senior nurses or infant feeding co-ordinators in neonatal units across the UK 3. The consensus-building and stakeholder workshops will include representatives from Neonatal Networks, professional associations (Neonatal Nurses Association, British Association of Perinatal Medicine) and third sector organisations (e.g. Bliss, TAMBA, La Leche League).

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
Feasibility to undertake an RCT. This will be assessed using the secondary outcome measures combined into a narrative/qualitative assessment of issues such as fidelity, dose, reach of the intervention, participants response, unexpected consequences etc (as described in the model by Moore et al 2015). The data to inform this will be collected throughout the intervention implementation (Work package 3) rather than at specific time-points. At the end of the study we will present the qualitative/narrative findings to Stakeholders who will make the decision using the ADePT framework (Bugge et al 2013).

Secondary

MeasureTime frame
1. Frequency and length of feeds (and volume for bottle fed babies) assessed by reviewing patient notes on a daily basis until 2 weeks after discharge from the neonatal unit 2. Daily weight change: assessed by reviewing patient notes on a daily basis until 2 weeks after discharge from the neonatal unit 3. Length of stay in hospital assessed by reviewing patient notes after discharge 4. Number of days to establish full oral feeding assessed by reviewing patient notes or 2-week follow-up if baby is discharged to home while still tube feeding 5. Adherence to cue-based feeding protocol assessed by reviewing patient notes/interviews/patient care observation on a daily basis 6. Feeding outcomes (method and type of milk) at discharge and 2-week follow-up 7. Important trial outcomes for a future trial assessed interviews during hospital stay 8. Feasibility of longer term follow-up assessed using interviews during hospital stay 9. Experiences and acceptability of cue-based feeding assessed using interviews during hospital stay 10. Number of infants meeting eligibility criteria and number of infants recruited assessed using research nurse recruitment logs throughout study 11. Willingness of parents to be randomised assessed using interviews during hospital stay

Countries

England, Scotland, United Kingdom

Contacts

Public ContactBronagh Raftery
nursing-health-CUBSstudy@dundee.ac.uk01382388735

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026