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

NCT02471482 | Completed DMC

• 1 other identifier: Study No. 6 - 2013
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Premature Brain Oxygenation

Keywords

Near Infra Red Spectrometry; Cerebral oxygenation; Mozart music

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• 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.

• 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.

• 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.

Study Arms (2)

Music First group

EXPERIMENTAL

Mozart music lullaby 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 continuously) 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). This cycle is repeated every 6 hours for 24 hours. In addition, the behavioral response of baby is observed during the study period by video recording which will be in 'Mute' video mode and then reviewed by our developmental staff

Other: Mozart music lullaby

No Music First group

EXPERIMENTAL

No music in first 30 minutes of study followed by 10 minutes of "washout" period and then 30 minutes of Mozart music lullaby while recording same variables. This cycle was repeated every 6 hours for 24 hours.

Other: Mozart music lullaby

Interventions

Mozart music lullaby OTHER

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.

Also known as: Music

Music First group; No Music First group

Eligibility Criteria

• Age: 7 Days - 35 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Babies with major congenital abnormalities
• Intraventricular haemorrhage grade 3 and 4 or cystic periventricular leucomalacia on cranial ultrasound

Sponsors & Collaborators

• Coombe Women and Infants University Hospital: lead

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Faiza Yasin

  Neonatal Department, Coombe Women and Infants University Hospital, Dublin-8,Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: June 15, 2015
• Study Start: December 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2016-02