Sensitivity Training For Parents of Preterm Infants

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883974
• Other study ID #: Preterm Sensitivity Training
• Status: Completed
• Phase: N/A
• First received: April 17, 2009
• Last updated: October 28, 2009
• Start date: April 2004
• Est. completion date: September 2005

Study information

• Verified date: October 2009
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• > 30 weeks gestation

Exclusion Criteria:

• insufficient English

• congenital abnormality

• triplets and higher multiple births

• residence > 100 km from study site

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Development
• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• Sensitivity Training
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.

Locations

Country	Name	City	State
Australia	Austin Health	Melbourne	Victoria
Australia	Jeannette Milgrom	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
University of Melbourne	The Financial Markets Foundation for Children

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional magnetic resonance imaging		Preterm infants at full-term equivalent age (40 weeks post-menstrual age)	No
Secondary	Short-term medical stability		Birth to full-term eqivalent age (40 weeks post-menstrual age)	No