Sensitivity Training For Parents of Preterm Infants

Not Applicable

Completed

• Conditions: Development; Preterm Birth
• Interventions: Behavioral: Sensitivity Training

• Registration Number: NCT00883974
• Lead Sponsor: 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).

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2005-08
• Study Completion: 2005-09
• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-28
• Last Update Posted: 2009-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• > 30 weeks gestation

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sensitivity Training	-

Primary Outcome Measures

Name	Time	Method
Functional magnetic resonance imaging	Preterm infants at full-term equivalent age (40 weeks post-menstrual age)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Austin Health; 🇦🇺 Melbourne, Victoria, Australia

Jeannette Milgrom; 🇦🇺 Melbourne, Victoria, Australia