Evidence map›Paper›PMID 41145247›Full record

ArticleBMJ open2025

Impact of touch interventions on brain activity in moderately preterm infants: study protocol for a pilot randomised controlled trial.

Andrea Manzotti, Francesco Cerritelli, Erica Lombardi, Laura Tansini, Desdemona Pisanu, Debora Di Leo, Elisa Vergani, Andrea Righini, Filippo Arrigoni, Vassilios Fanos and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05853991 (Effects of Affective Touch, Therapeutic Touch), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05853991 naunknown statusnot on this map

Effects of Affective Touch, Therapeutic Touch (OMT), and Static/Nonspecific Touch on Brain Connectivity and Metabolic Biomarkers in Preterm Infants

TypeinterventionalSponsorCome CollaborationRan2023 to 2026Enrolled20ConditionsPreterm, Infant ALL, Premature, DiseaseArmsosteopathic manipulative treatment, Active comparator, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Andrea ManzottiRAISE Lab, Foundation COME Collaboration, Pescara, Italy manzottiandrea68@gmail.com.
Francesco CerritelliRAISE Lab, Foundation COME Collaboration, Pescara, Italy.ORCID http://orcid.org/0000-0002-2963-9620
Erica LombardiRAISE Lab, Foundation COME Collaboration, Pescara, Italy.
Laura TansiniDivision of Neonatology and Neonatal Intensive Care Unit, Vittore Buzzi Children's Hospital, Milan, Italy.
Desdemona PisanuDivision of Neonatology and Neonatal Intensive Care Unit, Vittore Buzzi Children's Hospital, Milan, Italy.
Debora Di LeoDivision of Neonatology and Neonatal Intensive Care Unit, Vittore Buzzi Children's Hospital, Milan, Italy.
Elisa VerganiRAISE Lab, Foundation COME Collaboration, Pescara, Italy.
Andrea RighiniDepartment of Paediatric Radiology and Neuroradiology, Vittore Buzzi Children's Hospital, Milan, Italy.
Filippo ArrigoniDepartment of Paediatric Radiology and Neuroradiology, Vittore Buzzi Children's Hospital, Milan, Italy.
Vassilios FanosDepartment of Surgical Sciences, University of Cagliari, Cagliari, Italy.
Maria RescignoHumanitas University, Milan, Italy.
Pierangelo VeggiottiPaediatric Neurology Unit, Vittore Buzzi Children's Hospital, Milan, Italy.
Gianluca ListaNICU, 'V. Buzzi' Children's Hospital, ASST-FBF-SACCO, Milan, Italy.ORCID http://orcid.org/0000-0002-6636-5673
Diego GazzoloNeonatal Intensive Care Unit, Gabriele d'Annunzio University of Chieti and Pescara, Chieti, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionImproving the quality of life for preterm children is a global health priority, given their vulnerability to neurocognitive impairments and adverse health consequences. Lack of posthospital care further exacerbates these risks, necessitating effective interventions during the neonatal period. This protocol for a pilot study aims to investigate the effects of touch interventions, including physiotherapy and osteopathic manipulative treatment, on brain activity in moderately preterm infants using brain functional MRI (fMRI), computerised EEG and metabolomics. METHODS AND ANALYSIS: A 3-arm randomised sham-controlled trial will be conducted with 15 infants per experimental group. The study will include stable preterm infants born between 32.0 and 33.6 weeks of gestational age who do not require any intensive care treatments.The study aims to assess the impact of touch interventions on brain activity and metabolic sequelae. Using fMRI will primarily examine the pre-post changes between groups in blood oxygenation level dependent levels among different brain areas, specifically the anterior insula and the medial prefrontal cortex. Secondarily, we will explore the preterm brain's neural effects on EEG slow delta wave band. Metabolomics will provide data on the effects among the three groups on metabolic changes associated with touch interventions. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Ethics Committee of the local health agency in Milan (CET 449-2024). Understanding the effects of touch interventions on brain activity in moderately preterm infants, without needs of intensive care, can contribute to improving their clinical outcomes and promoting their growth, development and social behaviour. Findings from this pilot study will pave the way for future research, enabling the development of evidence-based interventions to enhance preterm infants' well-being and long-term outcomes. TRIAL REGISTRATION NUMBER: NCT05853991.

Indexed as

BrainInfant, PrematureTherapeutic TouchElectroencephalographyFemaleGestational AgeHumansInfant, NewbornMagnetic Resonance ImagingMalePilot ProjectsQuality of LifeRandomized Controlled Trials as TopicElectroencephalographyFunctional Magnetic Resonance ImagingNeonatal intensive & critical care

Identifiers

PMID41145247
PMCPMC12570928

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.