Clinical trial NCT00883974: 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
Overall status: COMPLETED
Phase: NA
Conditions: Development
Preterm Birth
Keywords: preterm bith
neurodevelopment
sensitivity training
magnetic resonance imaging (MRI)
Infant neurodevelopment following preterm birth
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: The Financial Markets Foundation for Children
First posted: 2009-04-20
Enrollment: 45
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* \> 30 weeks gestation

Exclusion Criteria:

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

Primary outcomes:
measure: Functional magnetic resonance imaging
timeFrame: Preterm infants at full-term equivalent age (40 weeks post-menstrual age)
Secondary outcomes:
measure: Short-term medical stability
timeFrame: Birth to full-term eqivalent age (40 weeks post-menstrual age)
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Jeannette Milgrom
state: Victoria
Study officials:
affiliation: University of Melbourne/Austin Health
name: Jeannette Milgrom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.