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

Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05853991
• Other study ID #: COME-23-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: March 2026

Study information

• Verified date: May 2023
• Source: Come Collaboration
• Contact: Andrea Manzotti
• Phone: +393484044783
• Email: manzotti.andrea68[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Weeks to 34 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Infant ALL
• Premature
• Premature Birth
• Preterm

Intervention

Other:
• osteopathic 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.
• Active comparator
Application of affective touch
• Placebo
Application of static touch

Locations

Country	Name	City	State
Italy	Ospedale dei bambini "Vittore Buzzi"	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Come Collaboration

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brain changes	pre-post changes in BOLD levels among different brain areas	1 hour
Secondary	electroencephalogram (EEG) changes	pre-post changes from baseline in the EEG power in slow delta waves band at the end of the treatment period	10 days
Secondary	Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T1	pre-post changes in urinary metabolites as assessed by 1H NMR at T1	1 hour
Secondary	Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T2	pre-post changes in urinary metabolites as assessed by 1H NMR at T2	4 days
Secondary	Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T3	pre-post changes in urinary metabolites as assessed by 1H NMR at T3	8 days
Secondary	Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T4	pre-post changes in urinary metabolites as assessed by 1H NMR at T4	12 days
Secondary	Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T5	pre-post changes in urinary metabolites as assessed by 1H NMR at T5	40 weeks
Secondary	Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T1	pre-post changes in urinary metabolites as assessed by CL-MS at T1	1 hour
Secondary	Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T2	pre-post changes in urinary metabolites as assessed by CL-MS at T2	4 days
Secondary	Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T3	pre-post changes in urinary metabolites as assessed by CL-MS at T3	8 days
Secondary	Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T4	pre-post changes in urinary metabolites as assessed by CL-MS at T4	12 days
Secondary	Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T5	pre-post changes in urinary metabolites as assessed by CL-MS at T5	40 weeks
Secondary	Mass Spectrometry combined with Gas Chromatography (CG-MS) at T1	pre-post changes in urinary metabolites as assessed by CG-MS at T1	1 hour
Secondary	Mass Spectrometry combined with Gas Chromatography (CG-MS) at T2	pre-post changes in urinary metabolites as assessed by CG-MS at T2	4 days
Secondary	Mass Spectrometry combined with Gas Chromatography (CG-MS) at T3	pre-post changes in urinary metabolites as assessed by CG-MS at T3	8 days
Secondary	Mass Spectrometry combined with Gas Chromatography (CG-MS) at T4	pre-post changes in urinary metabolites as assessed by CG-MS at T4	12 days
Secondary	Mass Spectrometry combined with Gas Chromatography (CG-MS) at T5	pre-post changes in urinary metabolites as assessed by CG-MS at T5	40 weeks