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Effects of Touch on Brain Connectivity and Metabolic Biomarkers in Preterm Infants

Effects of Affective Touch, Therapeutic Touch (OMT), and Static/Nonspecific Touch on Brain Connectivity and Metabolic Biomarkers in Preterm Infants

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05853991
Enrollment
20
Registered
2023-05-11
Start date
2023-06-30
Completion date
2026-03-31
Last updated
2023-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease, Infant ALL, Premature, Preterm

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).

Interventions

OTHERosteopathic manipulative treatment

The intervention will be based on the specific assessment and treatment of the preterm developed by the team and validated through different studies.

OTHERActive comparator

Application of affective touch

OTHERPlacebo

Application of static touch

Sponsors

Come Collaboration
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
32 Weeks to 34 Weeks
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
brain changes1 hourpre-post changes in BOLD levels among different brain areas

Secondary

MeasureTime frameDescription
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T11 hourpre-post changes in urinary metabolites as assessed by 1H NMR at T1
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T24 dayspre-post changes in urinary metabolites as assessed by 1H NMR at T2
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T38 dayspre-post changes in urinary metabolites as assessed by 1H NMR at T3
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T412 dayspre-post changes in urinary metabolites as assessed by 1H NMR at T4
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T540 weekspre-post changes in urinary metabolites as assessed by 1H NMR at T5
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T11 hourpre-post changes in urinary metabolites as assessed by CL-MS at T1
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T24 dayspre-post changes in urinary metabolites as assessed by CL-MS at T2
electroencephalogram (EEG) changes10 dayspre-post changes from baseline in the EEG power in slow delta waves band at the end of the treatment period
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T412 dayspre-post changes in urinary metabolites as assessed by CL-MS at T4
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T540 weekspre-post changes in urinary metabolites as assessed by CL-MS at T5
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T11 hourpre-post changes in urinary metabolites as assessed by CG-MS at T1
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T24 dayspre-post changes in urinary metabolites as assessed by CG-MS at T2
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T38 dayspre-post changes in urinary metabolites as assessed by CG-MS at T3
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T412 dayspre-post changes in urinary metabolites as assessed by CG-MS at T4
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T540 weekspre-post changes in urinary metabolites as assessed by CG-MS at T5
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T38 dayspre-post changes in urinary metabolites as assessed by CL-MS at T3

Countries

Italy

Contacts

Primary ContactAndrea Manzotti
manzotti.andrea68@gmail.com+393484044783
Backup ContactFrancesco Cerritelli
francesco.cerritelli@gmail.com+393394332801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026