Being born extremely preterm (i.e. <30 weeks gestation) or with very low birth weight (i.e. <1000 grams) Neonatal Diseases
Conditions
Interventions
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 randomisatio
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Inability of parents to understand and/or speak Dutch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed