Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000722594
Ethics application status
Approved
Date submitted
1/06/2015
Date registered
13/07/2015
Date last updated
27/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of daily 10 minute maternal voice on physiological and behavioral measures in premature infants in Neonatal Intensive Care Unit (NICU) : A Randomized Controlled Trial
Scientific title
Effect of maternal voice on physiological and behavioral measures in premature infants : A Randomized Controlled Trial
Secondary ID [1] 286837 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premature infants 295223 0
Condition category
Condition code
Reproductive Health and Childbirth 295469 295469 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Premature baby with corrected gestational age (CGA) between 27 to 35 weeks period of gestation (POG). CGA is calculated as POG plus current age of baby in weeks.

Subject will be exposed to recording of their mothers voice for 10 minutes every day for 2 weeks.

Their mother will be given a recorder prior to the study, she will be asked to record her voice in any form i.e. singing, talking,rhyming, reading for 10minutes.

The same recording will be played to their babies daily for 2 weeks.

The recording will be played during daytime, after feeding was given.

The volume of the sound will be kept at 50-55dB as recommended by American Academy of Paediatrics.

Their biophysical parameter (Heart Rate, Respiratory Rate, SPO2) and neurobehavioral score will be monitored pre, during and post intervention daily.
Intervention code [1] 291999 0
Behaviour
Intervention code [2] 292189 0
Treatment: Other
Comparator / control treatment
Control treatment will have biophysical profile monitored but not receiving their mothers voice.
Infants in control group will only be exposed to standard NICU noises/sounds
Control group
Active

Outcomes
Primary outcome [1] 295199 0
To determine the effect of maternal voice vs NICU environmental sounds on physiological measures in premature infants.

The physiological changes measured are changes of Heart Rate (HR) , Respiratory Rate (RR), SPO2 in infants exposed to mother’s voice vs NICU environmental sound.

It is measured by using probe attached to recording monitor (Phillip Intellivue MP70).
Timepoint [1] 295199 0
Every 1 minute during 10 min pre, 1 min during and 1 min post intervention.
Primary outcome [2] 295404 0
To determine the effect of maternal voice vs NICU environmental sounds on behavioral measures in premature infants.

Neurobehavioral score is done by using Behavioral Indicators of Infant Pain (BIIP) score adapted from HOLSTI, L. & GRUNAU, R. E. (2007). It is a score that is using facial and hand coding that indicate infants pain.
Timepoint [2] 295404 0
Every 10 minute during 10 min pre, 10 min during and 10 min post intervention daily
Secondary outcome [1] 315028 0
To compare mean changes of Heart Rate (HR)in infants exposed to mother’s voice vs NICU environmental sound.
It is measured by using probe attached to recording monitor (Phillip Intellivue MP70).
Timepoint [1] 315028 0
Every 1 minute during 10 min pre, 10 min during and 1 min post intervention.
Study will be done daily for 2 weeks.
Secondary outcome [2] 315029 0
To compare mean weight gain between premature infants exposed to mother’s voice vs NICU environmental sound

Subject's weight will be measured on a standard digital weighing machine in NICU (SECA 728 baby scales)
Timepoint [2] 315029 0
After 14 days from date starting study
Subject's weight will be measured every alternate day for 2 weeks during study period.
Secondary outcome [3] 315030 0
To compare mean neurobehavioral score between premature infants exposed to mother’s voice vs NICU environmental sound

Neurobehavioral score is done by using Behavioral Indicators of Infant Pain (BIIP) score adapted from HOLSTI, L. & GRUNAU, R. E. (2007). It is a score that is using facial and hand coding that indicate infants pain.
Timepoint [3] 315030 0
Every 10 minute during 10 min pre, 10 min during and 10 min post intervention.
Study will be done daily for 2 weeks.
Secondary outcome [4] 315674 0
To compare mean changes of Respiratory Rate (RR) in infants exposed to mother’s voice vs NICU environmental sound.
It is measured by using probe attached to recording monitor (Phillip Intellivue MP70).
Timepoint [4] 315674 0
Every 1 minute during 10 min pre, 10min intervention, 10 min post intervention
Secondary outcome [5] 315675 0
To compare mean changes of SPO2 in infants exposed to mother’s voice vs NICU environmental sound.
It is measured by using probe attached to recording monitor (Phillip Intellivue MP70).
Timepoint [5] 315675 0
Every 1 minute during 10 min pre, 10 min intervention, 10 min post intervention

Eligibility
Key inclusion criteria
1. All premature infants with corrected gestational age (CGA) 27-35 weeks
2. Achieved full feeding of at least 120cc/kg/day
3. Infant must be nursed in closed incubator (isolette)
Minimum age
1 Days
Maximum age
8 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Premature baby who are on mechanical ventilation
2.Medically unstable infant: HIE, NEC, sepsis, on inotropic support
3.Infant with major congenital anomalies
4.Infant who is still on intravenous drip or parenteral nutrition

Dropout criteria
1.Infant who need to be ventilated during study period
2.Infant who need to be kept nil by mouth during study period
3.Infant who become medically unstable determined by treating clinician: HIE, NEC, sepsis, on inotropes etc


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed as randomization is created using computer software and allocation is sealed in opaque envelope and only will be open on the day of study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using computer software -randomizer.org
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Based on previous study by (Alipour et al., 2013), the sample size to achieve a power of 0.8, alpha level of 0.05, and the mean difference of 5 with standard deviation of 9.57 for physiological responses was 58 per group is needed. Therefore, total sample size of 140 is needed with 20% drop out.
(ALIPOUR, Z., ESKANDARI, N., HOSSAINI, S. K. E. & SANGI, S. 2013. Effect of vocal stimulation on responses of premature infants. Health, Spirituality and Medical Ethics,)

All data will be entered and analyze using SPSS version 18.

Descriptive analysis:Mean (SD) , Median (IQR) will be used to describe numerical data while number and percentage will be used for categorical data.

Independent t test and Chi Square test will be used to compare the demographic numerical and categorical data accordingly.

Repeated Measure ANOVA will be used to compare the difference in mean of the dependent variable between pre and post intervention group

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2015
Actual
1/06/2015
Date of last participant enrolment
Anticipated
30/11/2015
Actual
10/11/2015
Date of last data collection
Anticipated
Actual
24/11/2015
Sample size
Target
140
Accrual to date
Final
140
Recruitment outside Australia
Country [1] 6922 0
Malaysia
State/province [1] 6922 0
Kedah

Funding & Sponsors
Funding source category [1] 291385 0
Self funded/Unfunded
Name [1] 291385 0
Country [1] 291385 0
Primary sponsor type
Hospital
Name
HOSPITAL SULTANAH BAHIYAH
Address
Km 6, Jln Langgar,
05460 Alor Setar,
Kedah Darul Aman
Country
Malaysia
Secondary sponsor category [1] 290061 0
University
Name [1] 290061 0
Department of Paediatric
HOSPITAL UNIVERSITI SAINS MALAYSIA
Address [1] 290061 0
HOSPITAL UNIVERSITI SAINS MALAYSIA
Universiti Sains Malaysia Kampus Kesihatan
Jalan Raja Perempuan Zainab 2
16150 Kota Bharu Kelantan.
Country [1] 290061 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292941 0
Medical research & Ethics commitee Ministry of Health Malaysia
Ethics committee address [1] 292941 0
Ethics committee country [1] 292941 0
Malaysia
Date submitted for ethics approval [1] 292941 0
Approval date [1] 292941 0
19/03/2015
Ethics approval number [1] 292941 0
18906

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 478 478 0 0
/AnzctrAttachments/368669-18906_20150324_155714_173.pdf
Attachments [2] 479 479 0 0
/AnzctrAttachments/368669-Proposal nmrr31052015.pdf

Contacts
Principal investigator
Name 57734 0
Dr NURUL AMANI ABD GHANI
Address 57734 0
DEPARTMENT OF PAEDIATRIC
HOSPITAL UNIVERSITI SAINS MALAYSIA
Universiti Sains Malaysia Kampus Kesihatan
Jalan Raja Perempuan Zainab 2
16150 Kota Bharu Kelantan.
Country 57734 0
Malaysia
Phone 57734 0
+60124287558
Fax 57734 0
Email 57734 0
[email protected]
Contact person for public queries
Name 57735 0
NURUL AMANI ABD GHANI
Address 57735 0
DEPARTMENT OF PAEDIATRIC
HOSPITAL UNIVERSITI SAINS MALAYSIA
Universiti Sains Malaysia Kampus Kesihatan
Jalan Raja Perempuan Zainab 2
16150 Kota Bharu Kelantan.
Country 57735 0
Malaysia
Phone 57735 0
+60124287558
Fax 57735 0
Email 57735 0
[email protected]
Contact person for scientific queries
Name 57736 0
NURUL AMANI ABD GHANI
Address 57736 0
DEPARTMENT OF PAEDIATRIC
HOSPITAL UNIVERSITI SAINS MALAYSIA
Universiti Sains Malaysia Kampus Kesihatan
Jalan Raja Perempuan Zainab 2
16150 Kota Bharu Kelantan.
Country 57736 0
Malaysia
Phone 57736 0
+60124287558
Fax 57736 0
Email 57736 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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