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A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
Improving the outcome of infants born at <30 weeks' gestation--a randomized controlled trial of preventative care at
Alicia J Spittle1, Carmel Ferretti, Peter J Anderson
1Physiotherapy, School of Health Sciences, University of Melbourne, 200 Berkley Street, Parkville, Victoria 3052, Australia. alicia.spittle@thewomens.org.au
Insights
This study evaluated a home-based preventative care program for very preterm infants to enhance infant development and caregiver mental health. The program aims to improve cognitive, motor, and behavioral outcomes, supporting families in the crucial first year.
Area of Science:
- Neonatal care
- Developmental pediatrics
- Family medicine
Background:
- Very preterm infants (<30 weeks gestation) face high rates of neurodevelopmental problems.
- Early, multi-faceted interventions are needed to address cognitive, motor, and behavioral impairments.
- Caregiver mental health is a critical factor in early childhood development.
Purpose of the Study:
- To assess the effectiveness of a home-delivered preventative care program for very preterm infants and their families.
- To improve infant cognitive, motor, language, and behavioral regulation.
- To enhance caregiver-child interactions and caregiver mental health.
Main Methods:
- Randomized controlled trial comparing a 9-session home program with standard follow-up.
- Intervention delivered by a physiotherapist and psychologist over the first 12 months.
- Infants stratified by brain white matter injury severity; primary outcomes at 24 months corrected age (Bayley-III).
Main Results:
- Interim motor development assessed at 12 months corrected age (Alberta Infant Motor Scale, Neurological Sensory Motor Developmental Assessment).
- Caregiver questionnaires at 12 months assessed behavior, parenting, mental health, and social support.
- Primary outcomes at 24 months include cognitive, motor, language development, caregiver-child interaction, and caregiver well-being.
Conclusions:
- The study protocol outlines a comprehensive preventative care program for very preterm infants.
- The program targets key developmental and psychosocial outcomes for infants and caregivers.
- Findings will inform early intervention strategies for high-risk infant populations.
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.
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