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Trial registered on ANZCTR


Registration number
ACTRN12612000335897
Ethics application status
Approved
Date submitted
22/03/2012
Date registered
22/03/2012
Date last updated
30/08/2024
Date data sharing statement initially provided
30/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preterm infant massage by the mother
Scientific title
Early intervention centered on infant massage performed by the mother in preterm infants: effects on neurodevelopment at the clinical, electrophysiological and neuroradiological level.
Secondary ID [1] 280022 0
Nil
Universal Trial Number (UTN)
Trial acronym
PREMM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain development in preterm infants 285932 0
Prematurity 286136 0
Condition category
Condition code
Neurological 286122 286122 0 0
Other neurological disorders
Reproductive Health and Childbirth 286329 286329 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1
Intervention Group - Preterm Infants
A massage paradigm modified from the preterm massage
protocol of Tiffany Fields will be taught via one-on-one sessions to the mothers of the intervention group administered by a physiotherapist. Teaching sessions will start at day 12 of life. For each mother, 3 teaching sessions will be needed to explain the entire massage protocol. These sessions will last for approximately 45 mins per day over three consecutive days (days 12, 13 and 14 of life). Mothers will be asked to perform a minimum of one and a maximum of three massage sessions per day. Massage sessions will be preferably performed around 60 mins before feeding and at least 2 hours after the completion of the previous session. Each session will be subdivided into two parts. The first part will consist of a tactile stimulation: the infant will be gently placed prone and will be given moderate pressure stroking with the flats of the fingers. Head, neck, shoulders, buttocks, and both legs and arms will be stimulated. The second part will consist of a kinesthetic (motor) stimulation: the infant will be placed in a supine position and passive flexion/extension movements of the limbs in sequence will be provided. The mother will be specifically taught how to perceive newborn's feedbacks on the availability for receiving the massage. In the absence of availability by the newborn, mothers will put their hands in resting position. The approximate minimal duration of the protocol will be of 10 minutes for the first part and 5 minutes for the second part. A diary of time, number and duration of each session will be kept by the mothers for the duration of the intervention which will be the period from day 12 of life to term born equivalent age (approximately 42 weeks post menstrual age). Depending on the gestational age of the baby the duration of the intervention would be about 6-7 weeks.
Infants of the control group will undergo routine care intervention.
Intervention code [1] 284342 0
Treatment: Other
Comparator / control treatment
Arm 2
Control Group - Preterm Infants
Mothers and babies in this group will not take part in the massage intervention. They will receive standard care as per normal in the special care nursery.

Arm 3
Control Group - Term Born Infants
Mothers and babies in this group will not take part in the massage intervention. They will receive treatment as usual in the maternity ward nursery.
Control group
Active

Outcomes
Primary outcome [1] 286596 0
Brain Neuoimaging.
Several aspects of brain microstructure and function will be examined: 1) Regional and global cortical surface and thickness, 2) white matter organization, 3) functional and structural connectivity of relevant areas, 4) brain representation of visual and somatosensory function.
Timepoint [1] 286596 0
An MRI will be performed on the infants at 42 weeks postmenstrual age.
Primary outcome [2] 286597 0
Electrophysiology.
EEG recordings will be obtained from all infants. A quantitatvie assessment of the EEG will be performed, including coherence analysis and spectral analysis.
Timepoint [2] 286597 0
The EEG will be performed on the infants at 42 weeks postmenstrual age.
Primary outcome [3] 286598 0
Dubowitz Neonatal Neurological Assessment.
This assesses the neurologcial health of the infant by assessing reflex ability, tone of muscles, posture and visual functioning.
Timepoint [3] 286598 0
The Dubowitz assessment will be performed at Baseline and 42 weeks postmenstrual age.
Secondary outcome [1] 296232 0
Mother to infant Bonding assessment.
This questionnaire assesses the bonding attachment between mother and infant.
Timepoint [1] 296232 0
The questionnaires will be given at Baseline, 42 weeks postmenstrual age, 12 months corrected age, and 24 months corrected age.
Secondary outcome [2] 296233 0
Edinburgh Postnatal Depression Scale (EPDS).
Scores from this questionnaire will be correlated with the infant's neurological health.
Timepoint [2] 296233 0
The questionnaires will be given at Baseline, 42 weeks postmenstrual age and 12 months corrected age.
Secondary outcome [3] 296234 0
Depression, Anxiety and Stress Scales (DASS).
Scores from this questionnaire will be correlated with the infant's neurological health.
Timepoint [3] 296234 0
The questionnaires will be given at Baseline, 42 weeks postmenstrual age, 12 months corrected age, and 24 months corrected age.
Secondary outcome [4] 296235 0
Maternal Self-Efficacy Scale (MSES).
This questionnaire measures mothers' perceived self-competence of their maternal practice.
Timepoint [4] 296235 0
12 and 24 months corrected age.
Secondary outcome [5] 296236 0
Infant and parent interaction observation.
This interaction observation is performed by a psychotherapist who observes the social and emotional development of the mother and infant dyad.
Timepoint [5] 296236 0
Baseline, 42 weeks postmenstrual age, 12 months corrected age and 24 months corrected age.
Secondary outcome [6] 296237 0
Prechtl's method on the qualitatvie assessment of general movements.
The flow and spontaneity of movement from the infant will be correlated with neurological health scores from the EEG, MRI and Dubowitz.
Timepoint [6] 296237 0
Baseline and 42 weeks postmenstrual age.
Secondary outcome [7] 296238 0
Bayley III.
Timepoint [7] 296238 0
24 months corrected age.
Secondary outcome [8] 296245 0
Infant Toddler Social and Emotional Assessment (ITSEA).
Assesses social and emotional problems and competencies in 4 domains of behaviour: behavioural dysregulation, externalising behaviour problems, internalising behaviour problems and competencies.
Timepoint [8] 296245 0
24 months corrected age.

Eligibility
Key inclusion criteria
1) gestational age must be between 28 weeks and 32.6 weeks for group 1 and 2 babies
2) birthweight above 10th percentile
3) clinically stable and not on oxygen therapy
4) they present no brain abnormalities on brain ultrasound
5) they present with no major genetic disorders or malformations
6) they are a singleton
7) reside within 100km and willing to return for followup
8) group 3 babies need to have a gestational age of at least 37 weeks
Minimum age
28 Weeks
Maximum age
33 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) birthweight below 10th percentile
2) clinically unstable and on oxygen therapy
3) they present with brain abnormalities on brain ultrasound
4) they present with major genetic disorders or malformations
5) they are not a singleton
6) reside outside of 100km.
7) gestational age greater than 33 weeks or less than 26.6 weeks

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)
After it has been identified that the infant is clinically stable and fulfils the inclusion criteria, the attending neonatalogist will provide information to the parents of potential subjects. Those parents that express interest will then be approached by a researcher to obtain consent. Baseline procedures will then be carried out before randomization. Sealed opaque envelopes are to be used to allocate the treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation) will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Preterm Infants in the massage arm will be given the intervention, while the preterm infants in the control arm are not.

Full term infants do not receive any intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/03/2010
Actual
16/03/2010
Date of last participant enrolment
Anticipated
Actual
3/10/2015
Date of last data collection
Anticipated
Actual
7/04/2017
Sample size
Target
50
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27053 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 5150 0
4029

Funding & Sponsors
Funding source category [1] 284777 0
Hospital
Name [1] 284777 0
Perinatal Research Centre (PRC)
Country [1] 284777 0
Australia
Primary sponsor type
Individual
Name
Naoni Ngenda
Address
Grantley Stable Unit (GSNU)
Physiotherapy Department
Royal Brisbane & Women's Hospital
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 283665 0
Individual
Name [1] 283665 0
Professor Paul Colditz
Address [1] 283665 0
Perinatal Research Centre
Royal Brisbane & Women's Hospital
Cnr Butterfield St and Bowen Bridge Rd
Herston QLD 4029
Country [1] 283665 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286770 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 286770 0
Ethics committee country [1] 286770 0
Australia
Date submitted for ethics approval [1] 286770 0
29/09/2009
Approval date [1] 286770 0
02/12/2009
Ethics approval number [1] 286770 0
HREC/09/QRBW/296
Ethics committee name [2] 286956 0
Qld Children's Health Services (RCH) Human Research Ethics Committee
Ethics committee address [2] 286956 0
Ethics committee country [2] 286956 0
Australia
Date submitted for ethics approval [2] 286956 0
05/03/2012
Approval date [2] 286956 0
19/03/2012
Ethics approval number [2] 286956 0
HREC/12/QRCH/40

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33829 0
Dr Melissa Lai
Address 33829 0
Perinatal Research Centre
University of Queensland Centre for Clinical Research
Level 4
Building 71/918
Royal Brisbane & Women's Hospital Campus
Herston, QLD, 4029
Country 33829 0
Australia
Phone 33829 0
+61 7 3346 5555
Fax 33829 0
Email 33829 0
melissa.lai@uq.edu.au
Contact person for public queries
Name 17076 0
Melissa Lai
Address 17076 0
Perinatal Research Centre
University of Queensland Centre for Clinical Research
Level 4
Building 71/918
Royal Brisbane & Women's Hospital Campus
Herston, QLD, 4029
Country 17076 0
Australia
Phone 17076 0
+61 7 3346 5555
Fax 17076 0
Email 17076 0
melissa.lai@uq.edu.au
Contact person for scientific queries
Name 8004 0
Paul Colditz
Address 8004 0
Perinatal Research Centre
Royal Brisbane & Women's Hospital
Cnr Butterfield St and Bowen Bridge Rd
Herston QLD 4029
Country 8004 0
Australia
Phone 8004 0
+61 07 3636 1761
Fax 8004 0
+61 07 3636 1769
Email 8004 0
p.colditz@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbasePREMM: Preterm early massage by the mother: Protocol of a randomised controlled trial of massage therapy in very preterm infants.2016https://dx.doi.org/10.1186/s12887-016-0678-7
N.B. These documents automatically identified may not have been verified by the study sponsor.