Condition category
Mental and Behavioural Disorders
Date applied
04/04/2016
Date assigned
19/04/2016
Last edited
19/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
About 11% of all babies born worldwide are preterm (premature) meaning that they are born more than three weeks before their due date. Premature babies have had less time to develop in the womb, and so often have a low birth weight. Although some premature children do very well at school, generally they have a higher chance of developing attention problems or learning difficulties than other children of the same age. It is thought that the earlier a child was born and the lower the weight at birth, the higher this risk becomes. Therapeutic Listening is a programme designed to improve cognitive function (learning, thinking and memory) and attention by using different sounds designed to stimulate brain activity. The aim of this study is to find out what effect Therapeutic Listening has on the cognitive development of children born prematurely who had a very low birth weight.

Who can participate?
Children aged three to four with attention and/or learning difficulties who had an extremely low weight when they were born.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in the Therapeutic Listening Programme. This involves children listening to modified music for 20-30 minutes twice per day for five days per week for a period of 6 months. The modified music sections is played on a San Disk Sports Clip (MP3 player) and played through sennheiser HD500A headphones which are specifically designed for the Therapeutic Listening programme. Those in the second group continue as normal and do not take part in any additional therapy. Participants in both groups are assessed by a Speech and Language Therapist, an Occupational Therapist and a Psychologist at the start of the study and after six months. Children who receive the Therapeutic Listening are also assessed every six weeks throughout the programme to monitor their progress.

What are the possible benefits and risks of participating?
Participants may benefit from improved attention and listening skills, language skills and motor skills, which will enhance learning skills. There are no notable risks involved with taking part in the study.

Where is the study run from?
National Maternity Hospital (Ireland)

When is the study starting and how long is it expected to run for?
February 2016 to December 2016

Who is funding the study?
Private individual (Ireland)

Who is the main contact?
1. Ms Marie Slevin (public)
2. Ms Karen O’Connor (scientific)
enquiries@thechilddevelopmentcentre.com

Trial website

Contact information

Type

Scientific

Primary contact

Ms Marie Slevin

ORCID ID

http://orcid.org/0000-0002-7572-5925

Contact details

National Maternity Hospital
Holles Street
Dublin
D02YH21
Ireland

Type

Scientific

Additional contact

Ms Karen O'Connor

ORCID ID

Contact details

The Child Development Centre
Knocknavaddy
Furbo
Galway County
00000000
Ireland
+353 87 2137025
enquiries@thechilddevelopmentcentre.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Music is the Key: Optimising Neurodevelopmental Outcome for the Preterm Infant

Acronym

Study hypothesis

The aim of this study is to identify an effective treatment programme within this population of preterm children that could become an integral part of their developmental pathway going forward to ensure that they achieve their full potential in listening, attention, motor,language and learning.

Ethics approval

Ethics Research Committee Board, National Maternity Hospital, Holles Street, Dublin, 04/012016

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Please see additional files

Condition

Development in premature infants

Intervention

Participants are randomly allocated to one of two groups.

Intervention group: Participants undergo the home Therapeutic Listening Programme. This involves listening to modified music for 20-30 minutes twice per day for five days per week for a period of 6 months. The intervention group will be reviewed at 6 weekly intervals for monitoring, parent reviews and updating programme input as determined by progress being made.

Control group: Participants continue as normal without receiving any intervention.

Participants in both groups undergo 6 tests administered by a Speech and Language Therapist, and Ocupational Therpist and a Psychologist at baseline and six months.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Speech and language skills are measured using the Preschool Language Scales–5 and the Renfrew Action Picture Test (RAPT) at baseline and 6 months
2. Motor skills are measured using the Development of Attention Skill Scale at baseline and 6 months
3. Sensory skills are measured using the Winnie –Dunn Sensory Profile at baseline and 6 months
4. Cognitive development ((Verbal Comprehension Index; Visual Spatial Index; Working Memory Index; Full Scale IQ) is measured uisng the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV) at baseline and 6 months

Secondary outcome measures

Intervention group only:
1. Child's response to the programme, how consistent the programme has been, motor changes, speech and language changes, behavioural changes, social changes, self-care routine changes and learning changes are measured using the Home Listening Follow-up Form completed by parents on review dates (Wed 30th March 2016; Wed 4th May 2016; Wed 1st June 2016; Wed 6th July 2016 and during final review Wed 17th Aug 2016)
2. Emotional tone changes (i.e. more irritable/more animated, arousal level changes, motor changes, speech and language changes and behavioural changes) are measured through the listening therapist’s observations on review dates (Wed 30th March 2016; Wed 4th May 2016; Wed 1st June 2016; Wed 6th July 2016 and during final review Wed 17th Aug 2016)

Overall trial start date

16/10/2015

Overall trial end date

20/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 3 to 4 years
2. Extremely Low Birth Weight Infant (<1500g)
3. Identified as being at risk for attention/learning difficulties when assessed at 2 years corrected age

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Major complications/intellectual impairment i.e. Bayley scores >2SD below the mean
2. Hearing/visual impairment
3. Cerebral palsy
4. Currently taking medication
5. Life-limiting condition/acquired brain injury/seizures
6. Undergoing therapeutic listening.

Recruitment start date

25/09/2015

Recruitment end date

15/02/2016

Locations

Countries of recruitment

Ireland

Trial participating centre

National Maternity Hospital
Holles Street
Dublin
D02YH21
Ireland

Sponsor information

Organisation

National Maternity Hospital

Sponsor details

Holles Street
Dublin
D02YH21
Ireland
+353 1 6373100
mslevin@nmh.ie

Sponsor type

Other

Website

Funders

Funder type

Other

Funder name

Private individual

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plan to publish study results in a peer reviewed journal.

Intention to publish date

30/06/2017

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes