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)

Not Applicable

Completed

• Conditions: Feeding of preterm babies in neonatal units; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN13414304
• Lead Sponsor: HS Tayside

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34878383/ (added 09/12/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-22
• Study Completion: 2021-11-30
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 149

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

Does not meet inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).