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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2026-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Preterm Infant ALL Premature Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

osteopathic manipulative treatment

Intervention Type OTHER

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

Affective touch

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

Group Type ACTIVE_COMPARATOR

Active comparator

Intervention Type OTHER

Application of affective touch

Static touch

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Application of static touch

Interventions

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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.

Intervention Type OTHER

Active comparator

Application of affective touch

Intervention Type OTHER

Placebo

Application of static touch

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

32 Weeks

Maximum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes