Premature Brain Oxygenation Clinical Trial
Official title:
Effect of Mozart Music on Cerebral Oxygenation and Behavioural Response of Premature Infants Between 28-32 Weeks of Corrected Gestation
This study is intended to see the effect of Mozart music on oxygen content of brain of premature infants once they achieve corrected gestation of 28-32 weeks and are clinically stable. Each baby is its own control. Difference of Oxygenation of brain will be measured during period with and without music. In addition behavioural response of baby will be recorded during intervention
Study Group:
Stable Infants of corrected age of 28-32weeks will be enrolled at more than seven days age
according to inclusion criteria.
An informed written consent will be obtained from parents/guardians after providing
information leaflet and verbal explanation.
INCLUSION CRITERIA:
- Babies with corrected age of 28-32(28+0 to32+0) weeks of gestation, more than seven
days old
- Breathing spontaneously in room air or stable on nCPAP with FiO2 requirement less than
30%
- Not requiring inotropic support
- On full enteral feeds.
EXCLUSION CRITERIA:
- Babies with major congenital abnormalities
- Intraventricular haemorrhage grade 3 and 4 or cystic periventricular leucomalacia on
cranial ultrasound
Study Design:
A randomized crossover study will be conducted in tertiary care level at Coombe Women and
Infants University Hospital, Dublin.
As this is a randomized crossover study, each baby will act as his/her own control. Enrolled
babies will be randomized to 'Music' or 'No Music'. All babies will be studied one hour
after feed. The baby randomized to 'Music' will be played music for 30 minutes with
recording of cerebral oxygenation (by using Near infrared spectroscopy) and vital signs
(respiratory rate, heart rate, oxygen saturations and frequency of apneic episodes every 10
minutes) followed by 10 minutes of "washout" period and then period of no music for next 30
minutes (with same variables recorded as outlined for music session).
Baby randomized to 'No Music' will have no music in first 30 minutes of study followed by 10
minutes of "washout" period and then 30 minutes of music. This cycle will be repeated every
6 hours for 24 hours.
In addition the investigators will observe the behavioral response of baby during the study
period by video recording which will be 'Mute' video recorded and then reviewed by our
developmental staff. The behavior will be documented on 'Neonatal Behavioral Observation
Sheet'. The observations will include, in addition to vital signs, the facial expression,
posture and motor responses of baby during phases of music and no music.
The investigators plan to blind the study to the medical staff and also to the researchers
at the time of the study (using research blind mode on near infrared spectroscopy machine).
In this mode the data are stored, however not displayed at the time of the study.
Recorded Mozart Lullaby will be played. The noise level will be kept below 45db as
recommended by American Academy of Pediatrics and will be monitored by sound monitor placed
in incubator during the study period. Enrolled babies will have hearing screening performed
prior to discharge from hospital.
Randomization: Sealed opaque envelopes
Music:
The music used will be Mozart Lullaby. This will be played on a small MP3 that will be
placed baby's incubator 5cm away from baby's head. The noise level is aimed to be kept under
45dB as per hospital recommendation by adjusting volume of MP3 player. TheMP3 player will be
covered in a clean plastic bag for hygiene purpose. The background will be kept to minimum
during the study period.
Statistical analysis:
Statistical analysis will be performed using the SPSS software, V.17. Data will be analyzed
by t-test to determine significant difference of cerebral blood flow during phase with and
without music. Significance will be defined as p<0.05. As there are no data for normal brain
oxygenation for the cohort studied, the investigators plan to enroll 30 infants in the pilot
phase.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care