Improving the quality of life of preterm children by 2035 is the top priority of worldwide health organisations, including the WHO. Every year, 15 million preterm infants, particularly those under 32 weeks of age, are at significant risk of neurocognitive impairments with adverse health consequences (disability, developmental delay, disease), exacerbated by the lack of post-hospital care for newborns. Intervening on the health of the preterm newborn through certain types of "touch" from its first days of life to activate its cutaneous senses permits, in reality, a significant improvement in the clinical state of the infant, hence promoting its growth, development, and social behaviour. In the neonatal period, during which significant neurological development occurs, tactile interactions and close physical proximity between infants and caregivers have significant short-term effects on the health of premature infants (weight gain, brain and vision development) and medium- to long-term effects on their development and expression of sociability. The likelihood that a premature newborn may develop attention and autism spectrum disorders, brain, gastrointestinal, and respiratory difficulties, as well as sleep disorders during the preschool years, is so high that clinical and social settings must prioritise care. Utilizing functional magnetic resonance imaging (fRMI), computerized electroencephalogram (EEG), and metabolomics, the research aims to explore the effects of touch, including physiotherapy and manual therapy (OMT) approaches, on brain activity. This research intends to examine the impact of touch on premature infants' brain activity (physical biomarker) and metabolic activity (biological biomarker).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
The intervention will be based on the specific assessment and treatment of the preterm developed by the team and validated through different studies.
Application of affective touch
Application of static touch
Ospedale dei bambini "Vittore Buzzi"
Milan, Italy
brain changes
pre-post changes in BOLD levels among different brain areas
Time frame: 1 hour
electroencephalogram (EEG) changes
pre-post changes from baseline in the EEG power in slow delta waves band at the end of the treatment period
Time frame: 10 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T1
pre-post changes in urinary metabolites as assessed by 1H NMR at T1
Time frame: 1 hour
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T2
pre-post changes in urinary metabolites as assessed by 1H NMR at T2
Time frame: 4 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T3
pre-post changes in urinary metabolites as assessed by 1H NMR at T3
Time frame: 8 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T4
pre-post changes in urinary metabolites as assessed by 1H NMR at T4
Time frame: 12 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T5
pre-post changes in urinary metabolites as assessed by 1H NMR at T5
Time frame: 40 weeks
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T1
pre-post changes in urinary metabolites as assessed by CL-MS at T1
Time frame: 1 hour
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T2
pre-post changes in urinary metabolites as assessed by CL-MS at T2
Time frame: 4 days
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T3
pre-post changes in urinary metabolites as assessed by CL-MS at T3
Time frame: 8 days
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T4
pre-post changes in urinary metabolites as assessed by CL-MS at T4
Time frame: 12 days
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T5
pre-post changes in urinary metabolites as assessed by CL-MS at T5
Time frame: 40 weeks
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T1
pre-post changes in urinary metabolites as assessed by CG-MS at T1
Time frame: 1 hour
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T2
pre-post changes in urinary metabolites as assessed by CG-MS at T2
Time frame: 4 days
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T3
pre-post changes in urinary metabolites as assessed by CG-MS at T3
Time frame: 8 days
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T4
pre-post changes in urinary metabolites as assessed by CG-MS at T4
Time frame: 12 days
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T5
pre-post changes in urinary metabolites as assessed by CG-MS at T5
Time frame: 40 weeks
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