Sensitivity Training For Parents of Preterm Infants

Early Sensitivity Training for Parents of Preterm Infants: Impact on the Developing Brain

Sponsors

Lead Sponsor: University of Melbourne

Collaborator: The Financial Markets Foundation for Children

Source University of Melbourne
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.

Detailed Description

A randomized controlled trial of a parental sensitivity training program involving 45 women with infants born < 30 weeks gestational age. The intervention consisted of 10 individual sessions in the Neonatal Intensive Care Unit (NICU). Post-intervention, at term-equivalent age (40 weeks postmenstrual age), magnetic resonance (MR) imaging was performed to evaluate brain structure and development. Quantitative volumetric techniques were used to estimate overall and regional brain volumes for different tissue types including cerebrospinal fluid (CSF), cortical grey matter (CGM), deep nuclear grey matter (DNGM), unmyelinated white matter (UWM) and myelinated white matter (MWM). Diffusion tensor imaging (DTI) was used to evaluate the integrity and maturation of white matter by apparent diffusion coefficient (ADC) and fractional anisotropy (FA).

Overall Status Completed
Start Date April 2004
Completion Date September 2005
Primary Completion Date August 2005
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Functional magnetic resonance imaging Preterm infants at full-term equivalent age (40 weeks post-menstrual age)
Secondary Outcome
Measure Time Frame
Short-term medical stability Birth to full-term eqivalent age (40 weeks post-menstrual age)
Enrollment 45
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Sensitivity Training

Description: 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.

Arm Group Label: 1

Eligibility

Criteria:

Inclusion Criteria: - > 30 weeks gestation Exclusion Criteria: - insufficient English - congenital abnormality - triplets and higher multiple births - residence > 100 km from study site

Gender: Female

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jeannette Milgrom, PhD Principal Investigator University of Melbourne/Austin Health
Location
Facility:
Austin Health | Melbourne, Victoria, 3081, Australia
Jeannette Milgrom | Melbourne, Victoria, VIC 3081, Australia
Location Countries

Australia

Verification Date

October 2009

Responsible Party

Name Title: Jeannette Milgrom

Organization: University of Melbourne & Austin Health

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

Label: 2

Type: No Intervention

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov