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Sensitivity Training For Parents of Preterm Infants

NCT ID: NCT00883974

Last Updated: 2009-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-09-30

Brief Summary

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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

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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).

Conditions

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Development Preterm Birth

Keywords

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preterm bith neurodevelopment sensitivity training magnetic resonance imaging (MRI) Infant neurodevelopment following preterm birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Sensitivity Training

Intervention Type BEHAVIORAL

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.

2

Standard Neonatal Intensive Care Unit (NICU) procedures for the care of pre-term infants

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* \> 30 weeks gestation

Exclusion Criteria

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

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Financial Markets Foundation for Children

OTHER

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role lead

Responsible Party

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University of Melbourne & Austin Health

Principal Investigators

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Jeannette Milgrom, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne/Austin Health

Locations

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Austin Health

Melbourne, Victoria, Australia

Site Status

Jeannette Milgrom

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 19952869 (View on PubMed)

Other Identifiers

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Preterm Sensitivity Training

Identifier Type: -

Identifier Source: org_study_id