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Sensitivity Training For Parents of Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00883974
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : October 29, 2009
The Financial Markets Foundation for Children
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Development Preterm Birth Behavioral: Sensitivity Training Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Sensitivity Training for Parents of Preterm Infants: Impact on the Developing Brain
Study Start Date : April 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Functional magnetic resonance imaging [ Time Frame: Preterm infants at full-term equivalent age (40 weeks post-menstrual age) ]

Secondary Outcome Measures :
  1. Short-term medical stability [ Time Frame: Birth to full-term eqivalent age (40 weeks post-menstrual age) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • > 30 weeks gestation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00883974

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Australia, Victoria
Austin Health
Melbourne, Victoria, Australia, 3081
Jeannette Milgrom
Melbourne, Victoria, Australia, VIC 3081
Sponsors and Collaborators
University of Melbourne
The Financial Markets Foundation for Children
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Principal Investigator: Jeannette Milgrom, PhD University of Melbourne/Austin Health
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jeannette Milgrom, University of Melbourne & Austin Health Identifier: NCT00883974    
Other Study ID Numbers: Preterm Sensitivity Training
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: October 29, 2009
Last Verified: October 2009
Keywords provided by University of Melbourne:
preterm bith
sensitivity training
magnetic resonance imaging (MRI)
Infant neurodevelopment following preterm birth
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Immune System Diseases