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Impact of touch interventions on brain activity in moderately preterm infants: study protocol for a pilot randomised
Andrea Manzotti1,2,3,4, Francesco Cerritelli5,6, Erica Lombardi5,2
1RAISE Lab, Foundation COME Collaboration, Pescara, Italy manzottiandrea68@gmail.com.
Insights
This pilot study explores how touch interventions like physiotherapy impact brain activity in preterm infants. Findings aim to improve neurodevelopmental outcomes for vulnerable newborns.
Area of Science:
- Neonatal Neuroscience
- Developmental Pediatrics
- Integrative Medicine
Background:
- Preterm infants face risks of neurocognitive impairments and poor health outcomes, worsened by inadequate posthospital care.
- Early, effective interventions during the neonatal period are crucial for improving quality of life in preterm children.
- This study focuses on moderately preterm infants not requiring intensive care.
Purpose of the Study:
- To investigate the effects of touch interventions on brain activity in preterm infants.
- To assess changes in brain function using functional MRI (fMRI) and computerized EEG.
- To analyze metabolic changes associated with touch interventions using metabolomics.
Main Methods:
- A 3-arm randomized sham-controlled trial involving 15 stable preterm infants per group (gestational age 32.0-33.6 weeks).
- fMRI will measure blood oxygenation level dependent (BOLD) changes in the anterior insula and medial prefrontal cortex.
- Computerized EEG will assess neural effects in the slow delta wave band, and metabolomics will analyze metabolic changes.
Main Results:
- The study is a pilot and results are pending.
- Analysis will compare pre-post changes in brain activity and metabolic profiles between intervention and sham groups.
- fMRI, EEG, and metabolomics data will elucidate the impact of touch interventions.
Conclusions:
- Understanding touch intervention effects can improve clinical outcomes for preterm infants.
- This research aims to inform evidence-based practices for enhanced infant well-being and development.
- Findings will guide future interventions to support preterm children's long-term health and social behavior.
Introduction:
Improving 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.
