Effect of Mozart Music on Cerebral Oxygenation and Behavioural Response of Premature Infants
Condition: Premature Brain Oxygenation
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Mozart music lullaby
Intervention type(s): Other
Intervention description(s): 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.
Other intervention name(s): Music
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Near Infra Red Spectrometry; Cerebral oxygenation; Mozart music