ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000412538

Ethics application status

Approved

Date submitted

12/09/2006

Date registered

21/09/2006

Date last updated

21/09/2006

Type of registration

Prospectively registered

Titles & IDs

Public title

Improving neurobehavioural development in preterm infants

Scientific title

'Environmental intervention, using parent sensitivity training, to improve neurobehavioural development in preterm infants: A randomised controlled trial'.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Potential neurobehavioural and neurodevelopmental deficits associated with premature birth

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intensive parent sensitivity training in first 12 weeks following premature birth aimed at reducing infant stress.

Intervention code [1]

Prevention

Comparator / control treatment

Control Group mothers receive one psycho-educational session concerning coping with stress and copies of an educational booklet

Control group

Active

Outcomes

Primary outcome [1]

Neurobehavioural development as assessed by the Ages & Stages Questionnaire

Timepoint [1]

At 6 and 12 months.

Primary outcome [2]

Neurobehavioural development as assessed by the Bayley Scales of Infant Development (III) and the Child Behavior Checklist

Timepoint [2]

At 24 months of age.

Primary outcome [3]

Neurobehavioural development as assessed by the Short Temperament Scales

Timepoint [3]

At 6, 12 and 24 months.

Primary outcome [4]

Medical stablility

Timepoint [4]

At 40 weeks post-conceptual age.

Primary outcome [5]

The Neonatal Medical Index computed from hospital records

Timepoint [5]

At date of discharge.

Secondary outcome [1]

Timepoint [1]

Eligibility

Key inclusion criteria

Mothers of singleton or twin infants born at less than or equal to 30 weeks gestational age will be included.

Minimum age

Not stated

Maximum age

Not stated

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Families living outside a 100km radius of Melbourne, those with insufficient English, and those whose infants have a congenital abnormality will be excluded. Any mothers whose young age precludes them from giving fully informed consent will also be excluded.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central administration of a coded, blinded, independently pre-generated allocation schedule operated via a sytem of sealed, numbered, opaque, tamper-evident envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Variable-length permuted blocks, computer-generated random sequence, stratified with respect to study site and with respect to twin versus singleton families

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/10/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

160

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

Country [1]

Australia

Primary sponsor type

Other

Name

Parent-Infant Research Institute, Austin Health, Melbourne

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mercy Hospital for Women

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

02/06/2006

Ethics approval number [1]

R06/01

Ethics committee name [2]

Royal Womens Hospital

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

11/04/2006

Ethics approval number [2]

06/03

Summary

Brief summary

To date, intervention foci to improve neurobehavioural outcomes in preterm infants have been primarily medical. The intervention developed for this study is based on the observation of severe dysregulation in premature infants and the potential of sensitive maternal-infant interaction to modulate the damaging effects of stress on infants' general and brain development. In essence we aim to train mothers to be therapists to their own hospitalised preterm infant. The development of infants of intervention and control mothers will be assessed and compared at several ages until 24 months corrected age.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Jeannette Milgrom

Address

Parent-Infant Research Institute (PIRI)
Department of Clinical & Health Psychology
Heidelberg Repatriation Hospital,
Austin Health,
300 Waterdale Road
Heidelberg West
VIC 3081

Country

Australia

Phone

+61 03 9496 4496

Fax

+61 03 9496 4148

[email protected]

Contact person for scientific queries

Name

Professor Jeannette Milgrom

Address

Parent-Infant Research Institute (PIRI)
Department of Clinical & Health Psychology
Heidelberg Repatriation Hospital,
Austin Health,
300 Waterdale Road
Heidelberg West
VIC 3081

Country

Australia

Phone

+61 03 9496 4496

Fax

+61 03 9496 4148

[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

Source	Title	Year of Publication	DOI
Embase	Behavioural and cognitive outcomes following an early stress-reduction intervention for very preterm and extremely preterm infants.	2019	https://dx.doi.org/10.1038/s41390-019-0385-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically