Lactation-focused audio relaxation versus standard care for mothers of very preterm infants (the EXPRESS randomized clinical trial)

Background: Mothers of very premature newborns often have low milk supply. Systematic review has shown increased milk quantity with relaxation interventions. We hypothesized that a self-directed audio relaxation and lactation-specific visualization would increase milk quantity after very premature birth. Methods: Unmasked, randomized, controlled trial, recruiting 132 participants in four United Kingdom neonatal units. Eligible women had given birth to one or two infants between 23+0 and 31+6 weeks of gestation. The intervention was a 12-minute voice recording including breathing exercises, muscle relaxation and lactation-specific visualization. Primary outcome was the highest 24-hour breastmilk weight expressed on any of day 4, day 14 or day 21 after birth. Results: Mean birth gestation was 27.8 weeks’ (SD 2.4), with 26% of participants giving birth under 26 weeks’ (34/132). Adjusted mean difference in primary outcome was 73.9 grams (95% CI -61.7 to 209.5, p=0.28). Spielberger State-Trait Anxiety Index adjusted mean difference was -1.9 (-8.2 to 4.3, p=0.54). The majority of relaxation group participants felt the intervention was relaxing (32/42, 76%). Conclusion: There was no beneficial effect of this relaxation intervention on milk quantity. Mothers of very premature infants may value relaxation interventions but they are unlikely to have a large effect on milk quantity.