Early Intervention in Preterm Infants: Effects of a Parental Training Program on Neonatal Brain Development, Visual Functions and Neurobehavioral Outcome
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Premature Birth
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Neonatal Visual Assessment Battery to evaluate visual function
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Preterm infants, during their stay in the Neonatal Intensive Care Unit (NICU), face a period of stressful environment, which may negatively impact early brain development and subsequent neurobehavioral outcomes. This study aims to assess the effectiveness of training parents in reducing stressful experiences early in life and in enhancing brain development and long term developmental outcomes.
Detailed Description
Very preterm birth is associated with motor, cognitive and behavioral problems. Micro-structural brain abnormalities, even in the absence of focal lesions, have been documented by neuroimaging studies in preterm infants at term corrected age and later in childhood. These alterations in brain maturation occurring during the neonatal period may be implicated in long-term neurobehavioral disorders later experienced by preterm babies. However, there is increasing evidence that also negative environmental factors (intensive care, excessive sensory stimulation, paucity of parental contact etc.) can affect later outcomes. Potential benefits of early dyadic interaction and preterm baby massage in reducing the effects of the NICU stressor environment have been demonstrated. More recently, few studies have investigated visual function in preterm infants focusing on the potential role of early visual interaction to enhance attention and improve later neurodevelopment. The role of early intervention strategies to improve neurodevelopment has been recently emphasized. Early intervention programs based on the concept of "individualized care" have proved to be effective in promoting brain maturation and neurodevelopmental outcome. In this context, early interventions as the Mother Infant Transaction Program (MITP) and the Premie Start, both targeting parenting, have the greatest potential to have sustained effects on child development. In addition, recent studies have shown that exposure to stressful events in the neonatal period can cause epigenetic modifications in children born preterm; in particular alteration of serotonergic tone was observed, associated with methylation of the serotonin transporter gene, which could be implicated in the etiology of behavioral disorders observed in these children. In animal models these epigenetic effects appear to be influenced by maternal care that can epigenetically modulate the offsprings' stress response.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Gestational age between 25+0 and 29+6 weeks
Exclusion Criteria
- •major brain lesions as documented by cranial ultrasound (intraventricular hemorrhage \> 2 grade, cystic periventricular leukomalacia)
- •neurosensorial deficits (retinopathy of prematurity \> stage 2)
- •genetic syndromes and/or major congenital malformations
- •major neonatal comorbidities
- •Mothers are selected according to the following inclusion criteria: age over 18 years, good comprehension of Italian language, no obvious cognitive impairments or psychiatric disorders, no drug addiction and no single-parent families.
Outcomes
Primary Outcomes
Neonatal Visual Assessment Battery to evaluate visual function
Time Frame: 40 weeks postmenstrual age
Neonatal Visual Function is assessed using the Visual Assessment Battery developed by Ricci et al. The assessment evaluates the following items: Ocular spontaneous motility, ability to fix and follow a target, reaction to colour, visual acuity and visual attention at distance. Each item is scored as normal (score 0) or abnormal (score 1). The global score is then calculated as the sum of all the individual items, as designed by the authors.
Neonatal Behavior
Time Frame: 2 months corrected age
Neonatal behavior is assessed using the Neonatal Behavior Assessment Scale that evaluates: habituation, social-interactive, motor system, state organization and regulation, autonomic system, reflexes.
Secondary Outcomes
- Epigenetic changes(up to 48 weeks gestational age)
- overall duration of hospitalisation(up to 48 weeks gestational age)
- Head circumference (in centimeters) at 40 weeks postmenstrual age(40 week gestational age)
- Developmental outcome(24 months corrected age)
- Feeding with Human milk(up to 40 weeks gestational age)
- Brain development(40 weeks postmenstrual age)
- Acquisition of full oral feeding(up to 48 weeks gestational age)
- Neurodevelopmental outcome(5-6 years of age)
- Weight (in grams) at 40 weeks postmenstrual age(40 week gestational age)
- Length(in centimeters) at 40 weeks postmenstrual age(40 week gestational age)
- Behavioral outcome(5-6 years of age)
- Attention outcome(5-6 years of age)
- Neuromotor outcome(5-6 years of age)
- L1 promoter methylation levels on buccal swab(5-6 years of age)