Effect of Mozart Music on Cerebral Oxygenation and Behavioural Response of Premature Infants Between 28-32 Weeks of Corrected Gestation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Primary Endpoint
- Change in cerebral oxygenation values with and without Mozart music as assessed by near infra red spectroscopy
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 7 Days to 35 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in cerebral oxygenation values with and without Mozart music as assessed by near infra red spectroscopy
Time Frame: 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.
Using Near infra red spectroscopy electrodes placed over baby's scalp
Secondary Outcomes
- Oxygen saturation(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.)
- Apnea episode(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.)
- Heart rate(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.)
- Respiratory rate(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.)
- Behavioural response to Mozart music(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.)
Investigators
Faiza Yasin
Dr
Coombe Women and Infants University Hospital