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

Background Complications 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)?' Aims The 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 Outline The 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. Timelines Trial 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 & Dissemination This 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'.