Feeding of preterm babies in neonatal units Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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