Cue-based versus scheduled feeding for preterm infants transitioning from tube to oral feeding: the Cubs mixed-methods feasibility study.

Background: There is a lack of evidence of the effect of cue-based feeding compared with scheduled feeding on important outcomes for preterm infants.

Objectives: The objectives were as follows: (1) to describe the characteristics, components, theoretical basis and outcomes of approaches to feeding preterm infants transitioning from tube to oral feeding; (2) to identify operational policies, barriers and facilitators, and staff and parents' educational needs in neonatal units implementing cue-based feeding; (3) to co-produce an intervention for feeding preterm infants in response to feeding cues; (4) to appraise the willingness of parents and staff to implement and sustain the intervention; (5) to assess associated costs of implementing cue-based feeding; (6) to determine the feasibility and acceptability of a future trial; (7) to scope existing data-recording systems and potential outcome measures; and (8) to determine stakeholders' views of whether or not a randomised controlled trial of this approach is feasible.

Design: This was a mixed-methods intervention development and feasibility study comprising (1) a systematic review, case studies, qualitative research and stakeholder consensus; (2) the co-production of the intervention; (3) a mixed-methods feasibility study; and (4) an assessment of stakeholder preferences for a future evaluation.

Setting: Three neonatal units in the UK (two level 3 units and one level 2 unit).

Participants: Developmentally normal, clinically stable preterm infants receiving enteral feeds ( = 50), parents ( = 15 pre intervention development;  = 14 in the feasibility study) and health-care practitioners ( = 54 pre intervention development;  = 16 in the feasibility study).

Intervention: An evidence-informed multicomponent intervention comprising training, a feeding protocol, feeding assessment tools, supplementary training materials [including posters, a film and a narrated PowerPoint (Microsoft Corporation, Redmond, WA, USA) presentation] and the 'Our Feeding Journey' document.

Main Outcome Measures: The main outcome measures were recruitment and screening rates, infant weight gain, duration of the intervention, feeding outcomes, implementation outcomes (contextual facilitators and barriers, acceptability, adoption, appropriateness and fidelity) and stakeholder preferences for a future evaluation.

Results: The systematic review of 25 studies concluded that evidence in favour of cue-based feeding should be treated cautiously. The case studies and qualitative research highlighted contextual barriers to and facilitators of the implementation of cue-based feeding. The telephone survey found that many neonatal units are considering implementing cue-based feeding. We recruited 37% of eligible infants, and there was good retention in the study until discharge but a high loss to follow-up at 2 weeks post discharge. The mean number of days from intervention to transition to full oral feeding was 10.8, and the mean daily change in weight gain was 25 g. The intervention was acceptable to parents and staff, although there was dissatisfaction with the study documentation. Intervention training did not reach all staff. A cluster-randomised design with a composite outcome was suggested by stakeholders for a future study.

Limitations: The intervention was available only in English. Intervention training did not reach all staff. There was low recruitment to qualitative interviews and observations. Only a small number of medical staff engaged in either the training or the interviews.

Conclusions: It is feasible to implement a cue-based feeding intervention with improved training and documentation. Further work is needed to assess the feasibility of a future trial, noting evidence of existing lack of equipoise.

Future Work: The next steps are to digitalise the intervention and conduct a survey of all neonatal units in the UK.

Study Registration: This study is registered as PROSPERO CRD42018097317 and ISRCTN13414304.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 74. See the NIHR Journals Library website for further project information.