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
1 other identifier
interventional
20
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2023
CompletedFirst Posted
Study publicly available on registry
May 11, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedMay 17, 2023
May 1, 2023
1.8 years
February 7, 2023
May 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
brain changes
pre-post changes in BOLD levels among different brain areas
1 hour
Secondary Outcomes (16)
electroencephalogram (EEG) changes
10 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T1
1 hour
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T2
4 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T3
8 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T4
12 days
- +11 more secondary outcomes
Study Arms (3)
Therapeutic touch
EXPERIMENTALThe 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
Affective touch
ACTIVE COMPARATORParticipants will receive an affective touch intervention following the standardised procedure for affective touch
Static touch
PLACEBO COMPARATORParticipants will receive a static touch intervention following the standardised procedure for static touch
Interventions
The intervention will be based on the specific assessment and treatment of the preterm developed by the team and validated through different studies.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale dei bambini "Vittore Buzzi"
Milan, Italy
Related Publications (1)
Manzotti A, Cerritelli F, Lombardi E, Tansini L, Pisanu D, Di Leo D, Vergani E, Righini A, Arrigoni F, Fanos V, Rescigno M, Veggiotti P, Lista G, Gazzolo D. Impact of touch interventions on brain activity in moderately preterm infants: study protocol for a pilot randomised controlled trial. BMJ Open. 2025 Oct 27;15(10):e102964. doi: 10.1136/bmjopen-2025-102964.
PMID: 41145247DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2023
First Posted
May 11, 2023
Study Start
June 1, 2023
Primary Completion
March 1, 2025
Study Completion
March 1, 2026
Last Updated
May 17, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share