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

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 Overview

• Status: Not yet recruiting
• Conditions: Disease; Infant ALL; Premature; Preterm
• Intervention / Treatment: Other: osteopathic manipulative treatment; Other: Active comparator; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesco Cerritelli; Phone Number: +393394332801; Email: francesco.cerritelli@gmail.com
• Study Contact Backup: Name: Andrea Manzotti; Phone Number: +393484044783; Email: manzotti.andrea68@gmail.com

Study Locations

• Italy
  • Milan, Italy
    • Ospedale dei Bambini "Vittore Buzzi"
    • Contact: Gianluca Lista, PhD; Phone Number: +390257995801; Email: gianluca.lista@asst-fbf-sacco.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic touch; 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	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: Affective touch; Participants will receive an affective touch intervention following the standardised procedure for affective touch	Other: Active comparator; Application of affective touch
Placebo Comparator: Static touch; Participants will receive a static touch intervention following the standardised procedure for static touch	Other: Placebo; Application of static touch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
brain changes	pre-post changes in BOLD levels among different brain areas	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T1	pre-post changes in urinary metabolites as assessed by 1H NMR at T1	1 hour
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T2	pre-post changes in urinary metabolites as assessed by 1H NMR at T2	4 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T3	pre-post changes in urinary metabolites as assessed by 1H NMR at T3	8 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T4	pre-post changes in urinary metabolites as assessed by 1H NMR at T4	12 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T5	pre-post changes in urinary metabolites as assessed by 1H NMR at T5	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	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	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	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	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	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	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	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	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	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	40 weeks

Collaborators and Investigators

• Sponsor: Come Collaboration

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: COME-23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No