Sensitivity Training For Parents of Preterm Infants
Primary Purpose
Development, Preterm Birth
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Sensitivity Training
Sponsored by
About this trial
This is an interventional treatment trial for Development focused on measuring preterm bith, neurodevelopment, sensitivity training, magnetic resonance imaging (MRI), Infant neurodevelopment following preterm birth
Eligibility Criteria
Inclusion Criteria:
- > 30 weeks gestation
Exclusion Criteria:
- insufficient English
- congenital abnormality
- triplets and higher multiple births
- residence > 100 km from study site
Sites / Locations
- Austin Health
- Jeannette Milgrom
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Standard Neonatal Intensive Care Unit (NICU) procedures for the care of pre-term infants
Outcomes
Primary Outcome Measures
Functional magnetic resonance imaging
Secondary Outcome Measures
Short-term medical stability
Full Information
NCT ID
NCT00883974
First Posted
April 17, 2009
Last Updated
October 28, 2009
Sponsor
University of Melbourne
Collaborators
The Financial Markets Foundation for Children
1. Study Identification
Unique Protocol Identification Number
NCT00883974
Brief Title
Sensitivity Training For Parents of Preterm Infants
Official Title
Early Sensitivity Training for Parents of Preterm Infants: Impact on the Developing Brain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Melbourne
Collaborators
The Financial Markets Foundation for Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Development, Preterm Birth
Keywords
preterm bith, neurodevelopment, sensitivity training, magnetic resonance imaging (MRI), Infant neurodevelopment following preterm birth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Arm Description
Standard Neonatal Intensive Care Unit (NICU) procedures for the care of pre-term infants
Intervention Type
Behavioral
Intervention Name(s)
Sensitivity Training
Intervention 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.
Primary Outcome Measure Information:
Title
Functional magnetic resonance imaging
Time Frame
Preterm infants at full-term equivalent age (40 weeks post-menstrual age)
Secondary Outcome Measure Information:
Title
Short-term medical stability
Time Frame
Birth to full-term eqivalent age (40 weeks post-menstrual age)
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 30 weeks gestation
Exclusion Criteria:
insufficient English
congenital abnormality
triplets and higher multiple births
residence > 100 km from study site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannette Milgrom, PhD
Organizational Affiliation
University of Melbourne/Austin Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Jeannette Milgrom
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
VIC 3081
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
19952869
Citation
Milgrom J, Newnham C, Anderson PJ, Doyle LW, Gemmill AW, Lee K, Hunt RW, Bear M, Inder T. Early sensitivity training for parents of preterm infants: impact on the developing brain. Pediatr Res. 2010 Mar;67(3):330-5. doi: 10.1203/PDR.0b013e3181cb8e2f.
Results Reference
derived
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Sensitivity Training For Parents of Preterm Infants
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