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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471482
• Other study ID #: Study No. 6 - 2013
• Status: Completed
• Phase: N/A
• First received: November 7, 2014
• Last updated: February 22, 2016
• Start date: December 2013
• Est. completion date: July 2015

Study information

• Verified date: February 2016
• Source: Coombe Women and Infants University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 35 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Premature Birth
• Premature Brain Oxygenation

Intervention

Other:
• Mozart music lullaby
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Coombe Women and Infants University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cerebral oxygenation values with and without Mozart music as assessed by near infra red spectroscopy	Using Near infra red spectroscopy electrodes placed over baby's scalp	One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.	No
Secondary	Heart rate	Recorded every minute using continuous stream monitoring by bed master	One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.	No
Secondary	Respiratory rate	Recorded every minute using continuous stream monitoring by bed master	One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.	No
Secondary	Oxygen saturation	Recorded every minute using continuous stream monitoring by bed master	One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.	No
Secondary	Apnea episode	Recorded every minute using continuous stream monitoring by bed master	One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.	No
Secondary	Behavioural response to Mozart music	Continuous video made and later assessed by two developmental nurses and using Newborn Individualized Developmental Care and Assessment Program (NIDCAP)/observation sheet. Both nurses were blinded for time of music as video was mute.	One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.	No