Effect of Mozart Music on Cerebral Oxygenation and Behavioural Response of Premature Infants
Effect of Mozart Music on Cerebral Oxygenation and Behavioural Response of Premature Infants
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.
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