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Sensitivity Training For Parents of Preterm Infants

This study has been completed.
Sponsor:
Collaborator:
The Financial Markets Foundation for Children
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT00883974
First received: April 17, 2009
Last updated: October 28, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention
Development
Preterm Birth
 Behavioral: Sensitivity Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Sensitivity Training for Parents of Preterm Infants: Impact on the Developing Brain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • Functional magnetic resonance imaging [ Time Frame: Preterm infants at full-term equivalent age (40 weeks post-menstrual age) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short-term medical stability [ Time Frame: Birth to full-term eqivalent age (40 weeks post-menstrual age) ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: April 2004
Study Completion Date: September 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
No Intervention: 2
Standard Neonatal Intensive Care Unit (NICU) procedures for the care of pre-term infants

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).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 30 weeks gestation

Exclusion Criteria:

  • insufficient English
  • congenital abnormality
  • triplets and higher multiple births
  • residence > 100 km from study site
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883974

Locations
Australia, Victoria
Jeannette Milgrom
Melbourne, Victoria, Australia, VIC 3081
Austin Health
Melbourne, Victoria, Australia, 3081
Sponsors and Collaborators
University of Melbourne
The Financial Markets Foundation for Children
Investigators
Principal Investigator: Jeannette Milgrom, PhD University of Melbourne/Austin Health
  More Information

No publications provided by University of Melbourne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jeannette Milgrom, University of Melbourne & Austin Health
ClinicalTrials.gov Identifier: NCT00883974     History of Changes
Other Study ID Numbers: Preterm Sensitivity Training
Study First Received: April 17, 2009
Last Updated: October 28, 2009
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by University of Melbourne:
preterm bith
neurodevelopment
sensitivity training
magnetic resonance imaging (MRI)
Infant neurodevelopment following preterm birth

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on June 17, 2013