RT Journal Article SR Electronic T1 Longitudinal Study of music Therapy’s Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial JF BMJ Open JO BMJ Open FD British Medical Journal Publishing Group SP e025062 DO 10.1136/bmjopen-2018-025062 VO 9 IS 8 A1 Claire Ghetti A1 Łucja Bieleninik A1 Mari Hysing A1 Ingrid Kvestad A1 Jörg Assmus A1 Renee Romeo A1 Mark Ettenberger A1 Shmuel Arnon A1 Bente Johanne Vederhus A1 Tora Söderström Gaden A1 Christian Gold YR 2019 UL http://bmjopen.bmj.com/content/9/8/e025062.abstract AB Introduction Preterm birth has major medical, psychological and socioeconomic consequences worldwide. Music therapy (MT) has positive effects on physiological measures of preterm infants and maternal anxiety, but rigorous studies including long-term follow-up are missing. Drawing on caregivers’ inherent resources, this study emphasises caregiver involvement in MT to promote attuned, developmentally appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalisation and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development.Methods and analysis Design: international multicentre, assessor-blind, 2×2 factorial, pragmatic randomised controlled trial; informed by a completed feasibility study. Participants: 250 preterm infants and their parents. Intervention: MT focusing on parental singing specifically tailored to infant responses, will be delivered during NICU and/or during a postdischarge 6-month period. Primary outcome: changes in mother–infant bonding at 6-month corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: mother–infant bonding at discharge and at 12-month CA; child development over 24 months; and parental depression, anxiety and stress, and infant rehospitalisation, all over 12 months.Ethics and dissemination The Regional Committees for Medical and Health Research Ethics approved the study (2018/994/REK Nord, 03 July 2018). Service users were involved in development of the study and will be involved in implementation and dissemination. Dissemination of findings will apply to local, national and international levels.Trial registration number NCT03564184