(1) Does music influence brain development of the preterm infant;(2) Does music influence length of hospital stay for the preterm infant.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Prematuriteit, pasgeborenen en ontwikkelingsgerichte zorg
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Brain maturation as assessed by full EEG (recorded by a neonatal non-invasive,
so-called head-cap) and standard care cerebral ultrasound.
The main study endpoint will be functional brain maturation as measured by EEG.
A 40-minute EEG recording will be made within 24 hours before the start of the
first intervention, on day 5 of the intervention period and within 24 hrs after
the last intervention. The EEG recordings will be made using the ANT_neuro
'Neo' monitor (used in regular clinical practice) paired with the waveguardtm
neonatal caps, which have been used previously by the department and will be
used in the future as standard care (CE-approved, developed by ANT Neuro® ).
Spontaneous activity transient (SAT) - derived metrics, inter-bust interval
(IBI) and burst suppression ratio (BSR) will be computed. SATs will be computed
using the in-house SignalBase software*s SAT computation, which is partly based
on the algorithm as developed and described by Palmu et al. (2010). IBI and BSR
will be computed using the new nëo monitor software developed by ANT Neuro®1
(post-processing). Background pattern, sleep-wake rhythm (none, imminent,
normal) and presence/absence of convulsions will be assessed on the
corresponding amplitude-integrated EEG trace per the method of classification
described in Hellström-Westas, Rosén, Vries & Greisen, 2006). The primary
outcome variable will be the average percentage of time detected as SAT-event
over the whole of the recording.
Furthermore brain maturation will also be assessed using standard ultrasound
scans (prior and after the intervention). We will assess Corpus callosum to
fastigium distance (Roelants et al 2015).
Secondary outcome
Markers of physiological stability such as heart rate (HR), respiratory rate
(RR) and oxygen saturation (SaO2) are continuously monitored as part of the
standard care in the NICU and are time-locked recorded using an in-house
developed software program called Bedbase. Another program called SignalBase
allows post processing of these data.
Infant neurobehavior/state of arousal will be assessed before and after the
intervention using a behavioral assessments scale (including sleep stages).
Background summary
Although survival rates for infants born preterm have risen steadily over the
last decades, long term (neurological) outcome in this patient group is still
of major concern. Previous research has indicated that music may have
beneficial effects on the preterm infant. Music might help the infant organize
behavioural states, decreasing energy loss and leading to greater homeostasis.
With this study, we aim to assess the association of music on the brain
development of the preterm infant and on other parameters indicative of the
general wellbeing of the preterm infant.
Study objective
(1) Does music influence brain development of the preterm infant;
(2) Does music influence length of hospital stay for the preterm infant.
Study design
Single-blind, mono-centre randomized controlled trial
Intervention
The intervention starts at 30 weeks PMA when infants are born at 29 weeks PMA,
for infants born between 30-33 weeks PMA as soon as possible after admission,
but before 34 weeks.
A musical stimulus will be presented for duration of 8 minutes, once a day,
until discharge (with a minimum of 5 and a maximum of 15 days). The infants in
the experimental group will be subjected to lullabies specifically composed for
infants. The control group will not be exposed to the intervention
Study burden and risks
The intervention has been developed along the guidelines set in the literature
(frequency, duration of music exposure and music choice). There seems to be no
risk to the presentation of music in itself. Outcome variables with the
exception of EEG are collected as part of standard care. EEGs are often
performed in this population and carry no risk for the infant. The EEG*s are
non-invasive and are performed with an easy applicable, save, neonatal
head-cap. The set-up used for presentation of the stimulus is CE proven and in
addition approved by the medical technical team of the hospital and the
infection prevention advisors. The decibel level at which the stimulus is
presented will be strictly controlled and determined in accordance with the
American Association of Paediatrics* and other guidelines available in the
literature. Staff or parents may end stimulus presentation at any time if they
judge stimulus presentation is not received well.
Lundlaan 6
Utrecht 3584EA
NL
Lundlaan 6
Utrecht 3584EA
NL
Listed location countries
Age
Inclusion criteria
• PMA between 29-33 weeks at birth
• PMA between 30-34 weeks at the start of the intervention
• Not enrolled in any other intervention study
• Parental consent
Exclusion criteria
Invasive mechanical ventilation at the start of the study
Severe neurological injuries or severe congenital brain malformation
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 |
|---|---|
| CCMO | NL67709.041.18 |