Title: 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)
Funder: Chief Scientist Office, Scotland

Abstract: The transition to oral feeding is a critical stage for preterm infants. Cue-based feeding may have benefits for preterm infants and their parents, such as earlier achievement of full oral feeding, however, evidence is lacking on outcomes. Current practice in the UK is inconsistent and there are barriers to implementing cue-based feeding including challenging the predominant clinical focus on feeding volume and weight gain, and inconsistent support for parents and staff to interpret infant feeding cues. This 21-month multi-method study aims to develop a manualised intervention and appraise options for a future evaluation. The manualised intervention will incorporate training materials and evidence-based behaviour change components. At the end of the study, we will report on evaluation design options (RCT or non-RCT) based on feasibility and acceptability of conducting a future effectiveness study comparing cue-based feeding with scheduled feeding for preterm infants in NNUs. The proposed study comprises 4 work packages (WP): WP1 building the evidence-base: we will build the evidence to inform content and delivery of the intervention by conducting a systematic review to identify underpinning theories; components and characteristics; outcomes; and economic evaluations. We will synthesise case-studies of best practice in cue-based feeding, and conduct fieldwork comprising a telephone survey of Neonatal Network leads to map and understand: i) the range of approaches to the transition from tube to oral feeding, ii) the scope of data collection systems, iii) staff training needs, and qualitative research to explore parents’ and staff’s understanding and attitudes to cue-based feeding. WP2 intervention co-production: we will co-design the intervention including training requirements, based on findings of WP1, and stakeholder preferences. WP3 feasibility and process evaluation: we will assess the willingness of parents and staff to implement the intervention, explore the design of key elements, and determine the feasibility and acceptability, of conducting a future randomised controlled trial. The manualised intervention will be implemented in 3 neonatal units to cover a range of approaches to the transition to oral feeding in preterm infants, population characteristics, unit size and level, and breastfeeding rates. WP4 preparing next steps: we will host a stakeholder workshop to evaluate the evidence from prior WPs, and agree the final version of the intervention and the final framework of options to be appraised for the design of a clinical and cost-effectiveness study. The key outputs are a manualised intervention incorporating relevant training and implementation requirements; and an appraisal of design options and outcomes for a future study. The study will be overseen by an international stakeholder advisory group. A panel of 6 parents with relevant, recent experiences will contribute to the design, conduct and dissemination of the study. The multi-disciplinary team includes health service researchers, clinicians (neonatologists, advanced neonatal nurse, speech and language therapist), psychologist, parents’ organisation, epidemiologist and statistician, with expertise in infant feeding, neonatal care, parental experiences, behaviour change techniques, evidence synthesis, qualitative and quantitative research methods, health economics, including evaluation of complex interventions, and education and training.

Lay abstract: When babies are born early they might not have developed the coordination needed to suck, swallow and breathe as they feed. Before babies are ready to feed using their mouths (oral feeding), feeds can be given by a tube running from their mouth or nose into their stomach. When the baby is ready this can be changed to feeding through their mouth, by breast, bottle or a cup or spoon. Many babies at this stage are fed at set (scheduled) times while others are fed when they show signs that they are hungry (cue-based). Some research has shown that feeding babies when they show they are hungry might be beneficial for them and their parents. For example babies may be discharged from hospital earlier. Cue-based feeding may also allow parents to better understand the needs of their baby and become more involved in providing care. We aim to develop a written plan for cue-based feeding that includes training for healthcare professionals and education materials for parents, and to test this plan to see if it works in neonatal units and is acceptable to parents and staff. We will also find out if the plan could be tested in a future study comparing cue-based with scheduled feeding for preterm babies in neonatal units. The 21-month study will have 4 parts. 1. First we will review published evidence, and learn from neonatal units in the UK and Sweden that are successfully using cue-based feeding. We will survey Neonatal Networks in the UK to find out if how many units use cue-based or scheduled feeding, or a combination, and find out what staff training is needed. We will interview parents and staff to find out their experiences of feeding premature babies in neonatal units. 2. Next we will use all the information from part 1, and the views of parents, neonatal care staff, and research experts, to develop the written plans and training for staff and parents. 3. We will test the written plan in 3 neonatal units (2 in England and 1 in Scotland) to find out if parents and staff are willing to use it. We will select 3 different neonatal units to cover a range of approaches to the move to oral feeding in premature babies, different populations, unit sizes and type of care provided, and breastfeeding rates. We will also consult parents, neonatal care staff and research experts on whether it would be possible to do a study in the future to see which approach (cue-based or scheduled feeding) is most effective. 4. Finally, we will hold a meeting with parents, neonatal care staff, and research experts to agree the final version of the written plans, and a list of different ways of comparing cue-based with scheduled feeding for preterm babies in neonatal units. We will have an advisory group of experts to oversee the research team. We will also work with the charity Bliss to identify and support a group of about 6 parents who will help at key points of the project such as design of parent consent forms, and how we recruit parents. This will help to make sure that the research is carried out in a way that parents are able to understand and support and will help the researchers understand what the results of this research mean for parents. The group will help to design lay summaries of our findings and tell us how we can reach a wide audience of parents. Our study team includes neonatal doctors, an advanced neonatal nurse, a speech and language therapist, a psychologist, a member of a parents’ organisation, as well as experts in research methods.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH