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

Come Collaboration

Status: Not yet enrolling

Conditions: Infant ALL; Premature; Preterm; Disease

Treatments: Other: Placebo; Other: osteopathic manipulative treatment; Other: Active comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT05853991

COME-23-01

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 32 to 34 weeks old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 3 patient groups, including a placebo group

Therapeutic touch

Experimental group

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

Treatment:

Other: osteopathic manipulative treatment

Affective touch

Active Comparator group

Description:

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

Treatment:

Other: Active comparator

Static touch

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo