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

Primary Purpose

Preterm, Infant ALL, Premature

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
osteopathic manipulative treatment
Active comparator
Placebo
Sponsored by
Come Collaboration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm

Eligibility Criteria

32 Weeks - 34 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ospedale dei bambini "Vittore Buzzi"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Therapeutic touch

Affective touch

Static touch

Arm Description

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

Participants will receive an affective touch intervention following the standardised procedure for affective touch

Participants will receive a static touch intervention following the standardised procedure for static touch

Outcomes

Primary Outcome Measures

brain changes
pre-post changes in BOLD levels among different brain areas

Secondary Outcome Measures

electroencephalogram (EEG) changes
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 T1
pre-post changes in urinary metabolites as assessed by 1H NMR at T1
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T2
pre-post changes in urinary metabolites as assessed by 1H NMR at T2
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T3
pre-post changes in urinary metabolites as assessed by 1H NMR at T3
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T4
pre-post changes in urinary metabolites as assessed by 1H NMR at T4
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T5
pre-post changes in urinary metabolites as assessed by 1H NMR at T5
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T1
pre-post changes in urinary metabolites as assessed by CL-MS at T1
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T2
pre-post changes in urinary metabolites as assessed by CL-MS at T2
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T3
pre-post changes in urinary metabolites as assessed by CL-MS at T3
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T4
pre-post changes in urinary metabolites as assessed by CL-MS at T4
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T5
pre-post changes in urinary metabolites as assessed by CL-MS at T5
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T1
pre-post changes in urinary metabolites as assessed by CG-MS at T1
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T2
pre-post changes in urinary metabolites as assessed by CG-MS at T2
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T3
pre-post changes in urinary metabolites as assessed by CG-MS at T3
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T4
pre-post changes in urinary metabolites as assessed by CG-MS at T4
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T5
pre-post changes in urinary metabolites as assessed by CG-MS at T5

Full Information

First Posted
February 7, 2023
Last Updated
May 16, 2023
Sponsor
Come Collaboration
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1. Study Identification

Unique Protocol Identification Number
NCT05853991
Brief Title
Effects of Touch on Brain Connectivity and Metabolic Biomarkers in Preterm Infants
Official Title
Effects of Affective Touch, Therapeutic Touch (OMT), and Static/Nonspecific Touch on Brain Connectivity and Metabolic Biomarkers in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Come Collaboration

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm, Infant ALL, Premature, Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic touch
Arm Type
Experimental
Arm Description
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
Arm Title
Affective touch
Arm Type
Active Comparator
Arm Description
Participants will receive an affective touch intervention following the standardised procedure for affective touch
Arm Title
Static touch
Arm Type
Placebo Comparator
Arm Description
Participants will receive a static touch intervention following the standardised procedure for static touch
Intervention Type
Other
Intervention Name(s)
osteopathic manipulative treatment
Intervention Description
The intervention will be based on the specific assessment and treatment of the preterm developed by the team and validated through different studies.
Intervention Type
Other
Intervention Name(s)
Active comparator
Intervention Description
Application of affective touch
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Application of static touch
Primary Outcome Measure Information:
Title
brain changes
Description
pre-post changes in BOLD levels among different brain areas
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
electroencephalogram (EEG) changes
Description
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
Title
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T1
Description
pre-post changes in urinary metabolites as assessed by 1H NMR at T1
Time Frame
1 hour
Title
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T2
Description
pre-post changes in urinary metabolites as assessed by 1H NMR at T2
Time Frame
4 days
Title
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T3
Description
pre-post changes in urinary metabolites as assessed by 1H NMR at T3
Time Frame
8 days
Title
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T4
Description
pre-post changes in urinary metabolites as assessed by 1H NMR at T4
Time Frame
12 days
Title
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T5
Description
pre-post changes in urinary metabolites as assessed by 1H NMR at T5
Time Frame
40 weeks
Title
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T1
Description
pre-post changes in urinary metabolites as assessed by CL-MS at T1
Time Frame
1 hour
Title
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T2
Description
pre-post changes in urinary metabolites as assessed by CL-MS at T2
Time Frame
4 days
Title
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T3
Description
pre-post changes in urinary metabolites as assessed by CL-MS at T3
Time Frame
8 days
Title
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T4
Description
pre-post changes in urinary metabolites as assessed by CL-MS at T4
Time Frame
12 days
Title
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T5
Description
pre-post changes in urinary metabolites as assessed by CL-MS at T5
Time Frame
40 weeks
Title
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T1
Description
pre-post changes in urinary metabolites as assessed by CG-MS at T1
Time Frame
1 hour
Title
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T2
Description
pre-post changes in urinary metabolites as assessed by CG-MS at T2
Time Frame
4 days
Title
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T3
Description
pre-post changes in urinary metabolites as assessed by CG-MS at T3
Time Frame
8 days
Title
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T4
Description
pre-post changes in urinary metabolites as assessed by CG-MS at T4
Time Frame
12 days
Title
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T5
Description
pre-post changes in urinary metabolites as assessed by CG-MS at T5
Time Frame
40 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Manzotti
Phone
+393484044783
Email
manzotti.andrea68@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Cerritelli
Phone
+393394332801
Email
francesco.cerritelli@gmail.com
Facility Information:
Facility Name
Ospedale dei bambini "Vittore Buzzi"
City
Milan
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianluca Lista, PhD
Phone
+390257995801
Email
gianluca.lista@asst-fbf-sacco.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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