Our first aim is to study whether it is feasible to provide live-music therapy for extremely preterm infants. Our second aim is to evaluate possible effects of live-music-therapy, to serve as a basis for power calculations in a larger study. This…
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For the current protocol we define the concept of feasibility as follows:
(a) Drop-out of children is lower than 20%
(b) The sessions are not increasing stress for the child
(c) Participant rate of parents is >50%
(d) >50% of parents evaluate the intervention as positive
(e) >50% of caregivers evaluate the intervention as positive
A drop-out regards children that are not stable enough to participate in the
sessions. This stability is determined by the treating physician and nurses.
Before, during and after each session, the music therapist will rate the
COMFORT-neo score of a child. These scores will be used to determine whether
the sessions are stressful for a child. During each session the heart rate,
blood pressure, respiration rate and oxygen saturation will be registered. In
the second week of therapy, General Movements (GMs) will be filmed before and
in the 2 hours after a session. Before the study period, after 3 weeks and
after 6 weeks, GMs will also be filmed, a stool sample will be collected and
parents will fill in a State and Trait Anxiety Inventory (STAI) and Beck's
Depression Inventory. At three months of age, all children will again be
videotaped to study Fidgety Movements (FMs).
Secondary outcome
Not applicable.
Background summary
Auditory brain development starts very early in gestation. From approximately
26 weeks* gestation, fetuses or preterm infants will be able to react to
auditory stimuli. Sounds a fetus hears within the womb include a mother*s
heartbeat, respiration and the maternal voice. Fetuses can react to these
stimuli and via an activity-dependent system of bone conduction, the inner ear
is stimulated. From 30 weeks* gestation onwards, the child will be able to
distinguish between different speeches and is able to process complex auditory
sounds. Because of preterm birth, this process is interrupted. Preterm infants
are subsequently admitted to the Neonatal Intensive Care Unit (NICU), where
they face many challenges. Among these challenges are the stress of physical
and sensorial influences as well as maternal separation. On the one hand, this
means that infants are exposed to noise in the NICU, that they may not yet be
able to process, which could be harmful and has been shown to alter respiratory
and cardiac functions. On the other hand, deprivation of the sounds heard in
utero could have consequences for auditory brain maturation and speech and
language development. Music might have an impact on preterm infants by three
mechanisms, a) reducing stress, b) improving parent-infant interaction and c)
offering an environmental enrichment to stimulate (auditory) brain development.
Through stress reduction, music might deliver structured patterns to the
developing brain, which in turn could lead to neurodevelopmental improvements.
Because extremely preterm infants have been excluded in many studies, the
feasibility of live-music therapy and the effects of live-music therapy are
unknown for this group. However, it might be crucial to provide live-music
therapy as early as possible to facilitate a more optimal outcome. Therefore,
with our study, we aim to investigate the feasibility of live-music therapy for
extremely preterm infants admitted to the NICU, and their parents.
Study objective
Our first aim is to study whether it is feasible to provide live-music therapy
for extremely preterm infants. Our second aim is to evaluate possible effects
of live-music-therapy, to serve as a basis for power calculations in a larger
study. This concerns a) the effects of live-music therapy on hemodynamics, b)
the effects of live-music therapy on infant and parental stress levels and
parent-child interaction and c) the effects of live-music therapy on short-term
neurological outcome.
Study design
This is a feasibility study investigating the feasibility of live-music
therapy for extremely preterm infants (N=10). After proved feasibility, we will
continue to study the effects of live-music therapy on an additional 40 infants
and their parents (total N=50).
Intervention
A music therapist will provide 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.
Study burden and risks
Data for this study cannot be obtained in another population, as the intention
is to study the feasibility of live-music for extremely preterm infants. As
this intervention may be stress-reducing and improving neurodevelopment, it is
worthwhile to study. We believe that the burden and risks associated with the
participation in this pilot study are small to non-existent. The possible
overstimulation by the live-music will be closely monitored by a trained music
therapist. Regarding outcomes, as DNA methylation will be locus-specific,
information will be collected without insights into genomic variations or
mutations, avoiding the risk to yield unwanted genetic information. *
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
- Extremely preterm children (gestational age <30 weeks and/or birth weight
<1000 grams) admitted to the Neonatal Intensive Care of the UMCG.
- Written informed consent from parents.
Exclusion criteria
Inability of the parents to understand/speak Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN94562698 |
| CCMO | NL68951.042.19 |