Improving the outcome of infants born at < 30 weeks' gestation - a randomized controlled trial of preventative care at home

Spittle, Alicia J., Ferretti, Carmel, Anderson, Peter J., Orton, Jane, Eeles, Abbey, Bates, Lisa, Boyd, Roslyn N., Inder, Terrie E. and Doyle, Lex W. (2009) Improving the outcome of infants born at < 30 weeks' gestation - a randomized controlled trial of preventative care at home. BMC Pediatrics, 9 Article #73: 1-14. doi:10.1186/1471-2431-9-73


Author Spittle, Alicia J.
Ferretti, Carmel
Anderson, Peter J.
Orton, Jane
Eeles, Abbey
Bates, Lisa
Boyd, Roslyn N.
Inder, Terrie E.
Doyle, Lex W.
Title Improving the outcome of infants born at < 30 weeks' gestation - a randomized controlled trial of preventative care at home
Journal name BMC Pediatrics   Check publisher's open access policy
ISSN 1471-2431
Publication date 2009-12-01
Year available 2009
Sub-type Article (original research)
DOI 10.1186/1471-2431-9-73
Open Access Status DOI
Volume 9
Issue Article #73
Start page 1
End page 14
Total pages 14
Editor Dr. Melissa Norton
Place of publication London, England, U.K.
Publisher BioMed Central
Language eng
Subject C1
9201 Clinical Health (Organs, Diseases and Abnormal Conditions)
1114 Paediatrics and Reproductive Medicine
Formatted abstract
Background

Early developmental interventions to prevent the high rate of neurodevelopmental problems in very preterm children, including cognitive, motor and behavioral impairments, are urgently needed. These interventions should be multi-faceted and include modules for caregivers given their high rates of mental health problems.
Methods/Design

We have designed a randomized controlled trial to assess the effectiveness of a preventative care program delivered at home over the first 12 months of life for infants born very preterm (<30 weeks of gestational age) and their families, compared with standard medical follow-up. The aim of the program, delivered over nine sessions by a team comprising a physiotherapist and psychologist, is to improve infant development (cognitive, motor and language), behavioral regulation, caregiver-child interactions and caregiver mental health at 24 months' corrected age. The infants will be stratified by severity of brain white matter injury (assessed by magnetic resonance imaging) at term equivalent age, and then randomized. At 12 months' corrected age interim outcome measures will include motor development assessed using the Alberta Infant Motor Scale and the Neurological Sensory Motor Developmental Assessment. Caregivers will also complete a questionnaire at this time to obtain information on behavior, parenting, caregiver mental health, and social support. The primary outcomes are at 24 months' corrected age and include cognitive, motor and language development assessed with the Bayley Scales of Infant and Toddler Development (Bayley-III). Secondary outcomes at 24 months include caregiver-child interaction measured using an observational task, and infant behavior, parenting, caregiver mental health and social support measured via standardized parental questionnaires.
Discussion

This paper presents the background, study design and protocol for a randomized controlled trial in very preterm infants utilizing a preventative care program in the first year after discharge home designed to improve cognitive, motor and behavioral outcomes of very preterm children and caregiver mental health at two-years' corrected age.
Clinical Trial Registration Number

ACTRN12605000492651
Keyword Birth-weight Infants
Motor Development
Preterm infants
Hospital Anxiety
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: 2010 Higher Education Research Data Collection
School of Medicine Publications
 
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Created: Sun, 10 Jan 2010, 10:09:16 EST