Clinical trial NCT05853991: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preterm
Infant ALL
Premature
Disease
Lead sponsor: Come Collaboration
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 32
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: brain changes
timeFrame: 1 hour
Secondary outcomes:
measure: electroencephalogram (EEG) changes
timeFrame: 10 days
measure: Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T1
timeFrame: 1 hour
measure: Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T2
timeFrame: 4 days
measure: Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T3
timeFrame: 8 days
measure: Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T4
timeFrame: 12 days
measure: Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T5
timeFrame: 40 weeks
measure: Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T1
timeFrame: 1 hour
measure: Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T2
timeFrame: 4 days
measure: Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T3
timeFrame: 8 days
measure: Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T4
timeFrame: 12 days
measure: Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T5
timeFrame: 40 weeks
measure: Mass Spectrometry combined with Gas Chromatography (CG-MS) at T1
timeFrame: 1 hour
measure: Mass Spectrometry combined with Gas Chromatography (CG-MS) at T2
timeFrame: 4 days
measure: Mass Spectrometry combined with Gas Chromatography (CG-MS) at T3
timeFrame: 8 days
measure: Mass Spectrometry combined with Gas Chromatography (CG-MS) at T4
timeFrame: 12 days
measure: Mass Spectrometry combined with Gas Chromatography (CG-MS) at T5
timeFrame: 40 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale dei bambini "Vittore Buzzi"
Study officials:
References: