Sensitivity Training For Parents of Preterm Infants
Early Sensitivity Training for Parents of Preterm Infants: Impact on the Developing Brain
Sponsors |
Lead Sponsor: University of Melbourne Collaborator: The Financial Markets Foundation for Children |
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Source | 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. |
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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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Overall Status | Completed | ||||||
Start Date | April 2004 | ||||||
Completion Date | September 2005 | ||||||
Primary Completion Date | August 2005 | ||||||
Phase | N/A | ||||||
Study Type | Interventional | ||||||
Primary Outcome |
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Secondary Outcome |
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Enrollment | 45 | ||||||
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Intervention |
Intervention Type: Behavioral Intervention Name: Sensitivity Training Description: 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. Arm Group Label: 1 |
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Eligibility |
Criteria:
Inclusion Criteria: - > 30 weeks gestation Exclusion Criteria: - insufficient English - congenital abnormality - triplets and higher multiple births - residence > 100 km from study site Gender: Female Minimum Age: N/A Maximum Age: N/A Healthy Volunteers: No |
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Overall Official |
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Location |
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Location Countries |
Australia |
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Verification Date |
October 2009 |
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Responsible Party |
Name Title: Jeannette Milgrom Organization: University of Melbourne & Austin Health |
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Keywords | |||||||
Has Expanded Access | No | ||||||
Condition Browse | |||||||
Number Of Arms | 2 | ||||||
Arm Group |
Label: 1 Type: Experimental Label: 2 Type: No Intervention Description: Standard Neonatal Intensive Care Unit (NICU) procedures for the care of pre-term infants |
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Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: Double (Participant, Outcomes Assessor) |