Award Title: Does a guided relaxation audio track increase yield of expressed milk and breastfeeding rates in mothers of very preterm infants? A small randomised controlled trial and nested exploratory work
Funder: Department of Health and Social Care

Abstract: BackgroundComplications arising from premature birth are the leading cause of neonatal death in the UK and infants who survive have increased rates of disability. Very preterm infants can't feed orally and are fed through a tube directly into the stomach. Receiving the maximum amount of mother's own milk improves outcomes, including survival. Despite this, mothers of preterm infants are at risk of poor milk supply. A Cochrane review showed that there are few randomised controlled trials related to human milk expression for premature babies. Research Question 'In mothers of babies born at less than 32 weeks' gestation (Population), does use of a guided relaxation and visualisation audio track (Intervention), compared to standard care (Control), increase expressed milk volume, rate of human milk feeding and measures of maternal mental health (Outcomes)?' AimsThe primary aim is to increase the volume of human milk expressed by mothers of very preterm babies and improve long-term human milk feeding outcomes for these babies. Study OutlineThe study will be a small non-blinded randomised controlled trial. Mothers of one or more infants born at 23-31 weeks' gestation and intending to express breastmilk for at least seven days will be recruited. Participants will be randomised either to routine care or to listen to a 15-minute intervention soundtrack while expressing milk, for 21 days or as long as desired beyond this time. Mothers will fill out questionnaires and weigh all expressed milk in a 24-hour period, at 3-4 time points in the first few weeks of their baby's life, depending on how premature the infant is. There is then a simple two-question outcome measurement at 36 weeks' post-menstrual age (PMA) - this is about a month before the baby's due date and is often near the time of discharge from hospital. Participants recruited in the first 14.5 months will continue longer follow up by completing the same outcome measurement at 9 and 18 weeks after term (approximately 2 and 4 months after the due date, respectively). Primary outcomes are maximum 24-hour weight of expressed milk by day 21 and proportion exclusively human milk feeding at 36 weeks PMA. Secondary outcomes are proportion expressing at least 750ml milk in 24 hours by day 21; maternal anxiety and distress scores; milk weight expressed per minute at day 21; proportion with any human milk feeding at 36 weeks PMA and proportion with exclusive human milk feeding at 18 weeks after term. TimelinesTrial recruitment period is 19 months. The length of an individual participants' involvement will be between 26 and 35 weeks, dependent on prematurity of the infant. Anticipated Impact & DisseminationThis intervention has the potential to benefit hundreds of thousands of preterm babies and their families globally. It is easily distributed by downloading the soundtrack. Findings will be disseminated to academics, neonatal teams and parents via established academic and clinical pathways, social media messaging and existing parent information sources such as charity partners 'Bliss' and 'Best Beginnings'.

Lay Abstract: Babies who are born early (prematurely) are more likely to have serious health problems, which can affect them for the rest of their lives. Being born early is also the most common cause of death for babies in the UK. Parents are more likely to be anxious and depressed when their baby is born early. We know that giving breastmilk to premature babies is very important for their health, but this isn't always easy for mothers. Being anxious may make it more difficult to express breastmilk. This is a trial for women who gave birth very early - when they were less than 7 months pregnant. It aims to increase the amount of breastmilk mothers can express, which in turn will improve their chances of breastfeeding their babies when they go home. Babies who are born this premature can't breastfeed directly, instead they have milk put into their stomach through a tube. The ideal milk to give to premature babies is breastmilk. Breastmilk prevents serious gut illnesses, infections and eye problems, and builds babies' brains for their long-term development. Mothers are advised to express milk from their breasts, by hand or using a pump, to give to their very premature babies. However, it can be hard for mothers who give birth this early to express enough breastmilk for their baby, which might stop them from exclusively breastfeeding when their baby is strong enough. This trial will randomly allocate half the mothers to listen to a relaxation and visualisation soundtrack while expressing milk and half the mothers to normal care while expressing milk. The soundtrack will talk the mother through tensing and relaxing their muscles to make them feel more relaxed, and also picturing their baby and imagining their milk flowing. We want to see if listening to the soundtrack increases the amount of milk mothers can express in the first three weeks after birth. We want to see if the soundtrack will help more mothers to exclusively breastfeed around the time their baby goes home. We will also look at whether mothers listening to the soundtrack feel less anxious or distressed. If this kind of simple, easily downloadable soundtrack improves mothers' milk supply, makes them more likely to breastfeed their babies and decreases their anxiety, it could help thousands of families in the UK and many more across the world.The trial will be conducted by a team of experts with experience in looking after premature babies and doing this kind of research. More than 650 mothers of premature babies have already helped plan the trial. They told us that their major problem was not being able to express enough milk, which is why this is the central question we will look at. Along with some of these mothers, the national neonatal charity Bliss will be on the team of people running this study. This will make sure that the research is looking at questions that are important to families, that information given to families is easy to understand and that families are at the heart of getting the study results to those who need them. We plan to present the results of the study to health professionals at conferences and in scientific journals. We will work with children's charity Best Beginnings to make new parent-friendly postcards explaining how best to express milk for premature babies and we will make social media-friendly bitesize summaries of the results for families to share online.

Research Activity Codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health Categories: REPRODUCTIVE HEALTH AND CHILDBIRTH