Effects of Touch on Brain Connectivity and Metabolic Biomarkers in Preterm Infants
- Conditions
- PretermPrematureDiseaseInfant ALL
- Interventions
- Other: osteopathic manipulative treatmentOther: PlaceboOther: Active comparator
- Registration Number
- NCT05853991
- Lead Sponsor
- Come Collaboration
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Preterm birth, between 32.0 and 33.6 weeks gestational age (GA);
- Absence of comorbidities that could affect the stability of vital parameters, and therefore represent a contraindication to the proposed intervention. Comorbities include sepsis, pathologies pertaining to surgery, respiratory or cardiovascular instability, birth from a drug-addicted or HIV-positive mother) or known congenital pathologies;
- Obtaining informed consent for participation in this research project from parents or legal guardians.
- Preterm infants born before 32.0 weeks of GA and after 34 weeks and with respiratory and neurological pathologies and any additional comorbities.
- Children whose parents will not read and sign or in case of failure to obtain informed consent will be excluded from the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Therapeutic touch osteopathic manipulative treatment The intervention will be based on 2 phases: 1) assessment to identify areas following the NAME procedure, 2) treatment to improve the function of the area identified Static touch Placebo Participants will receive a static touch intervention following the standardised procedure for static touch Affective touch Active comparator Participants will receive an affective touch intervention following the standardised procedure for affective touch
- Primary Outcome Measures
Name Time Method brain changes 1 hour pre-post changes in BOLD levels among different brain areas
- Secondary Outcome Measures
Name Time Method Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T1 1 hour pre-post changes in urinary metabolites as assessed by 1H NMR at T1
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T3 8 days pre-post changes in urinary metabolites as assessed by 1H NMR at T3
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T3 8 days pre-post changes in urinary metabolites as assessed by CL-MS at T3
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T5 40 weeks pre-post changes in urinary metabolites as assessed by 1H NMR at T5
electroencephalogram (EEG) changes 10 days pre-post changes from baseline in the EEG power in slow delta waves band at the end of the treatment period
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T2 4 days pre-post changes in urinary metabolites as assessed by 1H NMR at T2
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T4 12 days pre-post changes in urinary metabolites as assessed by 1H NMR at T4
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T1 1 hour pre-post changes in urinary metabolites as assessed by CL-MS at T1
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T2 4 days pre-post changes in urinary metabolites as assessed by CL-MS at T2
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T4 12 days pre-post changes in urinary metabolites as assessed by CL-MS at T4
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T5 40 weeks pre-post changes in urinary metabolites as assessed by CL-MS at T5
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T5 40 weeks pre-post changes in urinary metabolites as assessed by CG-MS at T5
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T1 1 hour pre-post changes in urinary metabolites as assessed by CG-MS at T1
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T2 4 days pre-post changes in urinary metabolites as assessed by CG-MS at T2
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T3 8 days pre-post changes in urinary metabolites as assessed by CG-MS at T3
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T4 12 days pre-post changes in urinary metabolites as assessed by CG-MS at T4
Trial Locations
- Locations (1)
Ospedale dei bambini "Vittore Buzzi"
🇮🇹Milan, Italy