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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Sensitivity Training For Parents of Preterm Infants
Scientific title
Early Sensitivity Training for Parents of Preterm Infants: Impact on the Developing Brain
Secondary ID [1] 0 0
Preterm Sensitivity Training
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Development 0 0
Preterm Birth 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Inflammatory and Immune System 0 0 0 0

Study type
Description of intervention(s) / exposure
Behaviour - Sensitivity Training

Experimental: 1 -

No Intervention: 2 - Standard Neonatal Intensive Care Unit (NICU) procedures for the care of pre-term infants

Behaviour: Sensitivity Training
The parent sensitivity training program was delivered in NICU (9 sessions) with a home-booster session. Therapists worked with parents following a manualized protocol. Targets of intervention included: recognizing signs of infant stress, "shut-down" mechanisms, alert-available behavior, motor behaviors, facial expressions,posture/muscle tone; graded stimulation; how to optimize interactions; touch, movement and massage; "kangaroo care" (nesting infants skin-to-skin against their mother); vocal, visual and multi-sensory stimulation; normalizing parental feelings; challenging dysfunctional thinking, and diary keeping.

Intervention code [1] 0 0
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Functional magnetic resonance imaging
Timepoint [1] 0 0
Preterm infants at full-term equivalent age (40 weeks post-menstrual age)
Secondary outcome [1] 0 0
Short-term medical stability
Timepoint [1] 0 0
Birth to full-term eqivalent age (40 weeks post-menstrual age)

Key inclusion criteria
- > 30 weeks gestation
Minimum age
No limit
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria
- insufficient English

- congenital abnormality

- triplets and higher multiple births

- residence > 100 km from study site

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment hospital [2] 0 0
Jeannette Milgrom - Melbourne
Recruitment postcode(s) [1] 0 0
3081 - Melbourne
Recruitment postcode(s) [2] 0 0
VIC 3081 - Melbourne

Funding & Sponsors
Primary sponsor type
University of Melbourne
Other collaborator category [1] 0 0
Name [1] 0 0
The Financial Markets Foundation for Children
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief summary
Immediately following birth, preterm infants face a period of stressful environmental inputs,
which may have negative consequences on early brain development and subsequent
neurobehavioral outcomes. This study aimed to assess the effectiveness of training parents in
reducing stressful experiences early in life. The investigators hypothesized that this
intervention would insulate preterm infants from the harmful effects of acute and chronic
stress, which in turn would result in enhanced brain development. The primary aim of the
current study was to investigate if this intervention was associated with improved brain
development measured by magnetic resonance imaging (MRI) at term-equivalent age. A secondary
aim was to assess some possible short-term medical benefits.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Jeannette Milgrom, PhD
Address 0 0
University of Melbourne/Austin Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications