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Clinical Trials/NCT00883974
NCT00883974
Completed
N/A

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

University of Melbourne2 sites in 1 country45 target enrollmentApril 2004

Overview

Phase
N/A
Intervention
Not specified
Conditions
Development
Sponsor
University of Melbourne
Enrollment
45
Locations
2
Primary Endpoint
Functional magnetic resonance imaging
Status
Completed
Last Updated
16 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 2004
End Date
September 2005
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • \> 30 weeks gestation

Exclusion Criteria

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

Outcomes

Primary Outcomes

Functional magnetic resonance imaging

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

Secondary Outcomes

  • Short-term medical stability(Birth to full-term eqivalent age (40 weeks post-menstrual age))

Study Sites (2)

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