Live music for preterm infants

INTERVENTION: After consent, eligible infants will be randomly assigned to one of the two arms, music therapy or care as usual. Assignment to treatment allocation will be done through a web portal. The randomisation schedule will be computer‐generated, using the method of randomised blocks. This trial will thereby be protected from selection bias by using concealed randomization. Infants in the music therapy group will start with the intervention in the first three weeks. Infants in the care as usual group will not yet receive the intervention. After three weeks the groups will cross‐over. The intervention entails a music therapist providing the infants with three weeks of live‐music, including two sessions per week. Each session of live‐music (two times a week) will last maximal 30 minutes, in which 10 to 20 minutes of actual music should be provided. In the sessions, the music therapist will tailor the contents of the music therapy for each individual infant. This includes choosing the appropriate instrument, determining the infant’s state, and while playing music continuously monitor the child and his/her reactions (aimed at relaxation, by particularly following respiration and respiratory patterns) but also looking for signs of overstimulation (such as tension, crying movements, hiccups, yawning or frowning). The music therapist will collaborate with parents in constructing the programme for the sessions. Parents will be actively involved in the sessions, to stimulate their role as caregiver and empower them. CONDITION: Being born extremely preterm (i.e. <30 weeks gestation) or with very low birth weight (i.e. <1000 grams) ; Neonatal Diseases PRIMARY OUTCOME: ; Feasibility, defined as; 1. Drop‐out of children is lower than 20%; 2. The sessions are not increasing stress for the child; 3. Participant rate of parents is >50%; 4. >50% of parents evaluate the intervention as positive; 5. >50% of caregivers evaluate the intervention as positive; Feasibility will be measured after the study has included 40 infants, but during the study the trialists will closely monitor for overstimulation according to COMFORTneo scores by the music therapist.; SECONDARY OUTCOME: ; 1. Hemodynamic parameters (i.e. heart rate, respiratory rate, blood pressure and oxygen saturation) measured before, during and after each therapy session; 2. Parental stress levels measured using the State and Trait Inventory (STAI) at baseline, after the three weeks of intervention and at discharge; 3. Infant stress levels measured using COMFORTneo scores before and after each therapy session; 4. Short‐term neurological outcome measured using General Movements Assessment at baseline, before and after a therapy session in the second week of therapy, after three weeks of intervention and at three months corrected age; INCLUSION CRITERIA: 1. Born with a gestational age < 30 weeks and/or with a birth weight < 1000 grams 2. Admitted to Neonatal Intensive Care Unit of the University Medical Center Groningen 3. Written informed consent from both parents