NCT00883974

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
Last Updated

October 29, 2009

Status Verified

October 1, 2009

Enrollment Period

1.3 years

First QC Date

April 17, 2009

Last Update Submit

October 28, 2009

Conditions

DevelopmentPreterm Birth

Keywords

preterm bithneurodevelopmentsensitivity trainingmagnetic resonance imaging (MRI)Infant neurodevelopment following preterm birth

Outcome Measures

Primary Outcomes (1)

  • Functional magnetic resonance imaging

    Preterm infants at full-term equivalent age (40 weeks post-menstrual age)

Secondary Outcomes (1)

  • Short-term medical stability

    Birth to full-term eqivalent age (40 weeks post-menstrual age)

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Sensitivity Training

2

NO INTERVENTION

Standard Neonatal Intensive Care Unit (NICU) procedures for the care of pre-term infants

Interventions

Sensitivity TrainingBEHAVIORAL

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.

1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \> 30 weeks gestation

You may not qualify if:

  • insufficient English
  • congenital abnormality
  • triplets and higher multiple births
  • residence \> 100 km from study site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Austin Health

Melbourne, Victoria, 3081, Australia

Location

Jeannette Milgrom

Melbourne, Victoria, VIC 3081, Australia

Location

Related Publications (1)

  • Milgrom J, Newnham C, Anderson PJ, Doyle LW, Gemmill AW, Lee K, Hunt RW, Bear M, Inder T. Early sensitivity training for parents of preterm infants: impact on the developing brain. Pediatr Res. 2010 Mar;67(3):330-5. doi: 10.1203/PDR.0b013e3181cb8e2f.

    PMID: 19952869DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jeannette Milgrom, PhD

    University of Melbourne/Austin Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 20, 2009

Study Start

April 1, 2004

Primary Completion

August 1, 2005

Study Completion

September 1, 2005

Last Updated

October 29, 2009

Record last verified: 2009-10

Locations

AU(2)