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Sensitivity Training For Parents of Preterm Infants

U

University of Melbourne

Status

Completed

Conditions

Development
Preterm Birth

Treatments

Behavioral: Sensitivity Training

Study type

Interventional

Funder types

Other

Identifiers

NCT00883974
Preterm Sensitivity Training

Details and patient eligibility

About

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.

Full 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).

Enrollment

45 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

  • > 30 weeks gestation

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 2 patient groups

1
Experimental group
Treatment:
Behavioral: Sensitivity Training
2
No Intervention group
Description:
Standard Neonatal Intensive Care Unit (NICU) procedures for the care of pre-term infants

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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