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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic touch | Experimental | 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 |
|
| Affective touch | Active Comparator | Participants will receive an affective touch intervention following the standardised procedure for affective touch |
|
| Static touch | Placebo Comparator | Participants will receive a static touch intervention following the standardised procedure for static touch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| osteopathic manipulative treatment | Other | The intervention will be based on the specific assessment and treatment of the preterm developed by the team and validated through different studies. |
| Measure | Description | Time Frame |
|---|---|---|
| brain changes | pre-post changes in BOLD levels among different brain areas | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| electroencephalogram (EEG) changes | pre-post changes from baseline in the EEG power in slow delta waves band at the end of the treatment period | 10 days |
| Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Manzotti | Contact | +393484044783 | manzotti.andrea68@gmail.com | |
| Francesco Cerritelli | Contact | +393394332801 | francesco.cerritelli@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale dei bambini "Vittore Buzzi" | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41145247 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| Active comparator | Other | Application of affective touch |
|
| Placebo | Other | Application of static touch |
|
pre-post changes in urinary metabolites as assessed by 1H NMR at T1
| 1 hour |
| Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T2 | pre-post changes in urinary metabolites as assessed by 1H NMR at T2 | 4 days |
| Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T3 | pre-post changes in urinary metabolites as assessed by 1H NMR at T3 | 8 days |
| Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T4 | pre-post changes in urinary metabolites as assessed by 1H NMR at T4 | 12 days |
| Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T5 | pre-post changes in urinary metabolites as assessed by 1H NMR at T5 | 40 weeks |
| Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T1 | pre-post changes in urinary metabolites as assessed by CL-MS at T1 | 1 hour |
| Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T2 | pre-post changes in urinary metabolites as assessed by CL-MS at T2 | 4 days |
| Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T3 | pre-post changes in urinary metabolites as assessed by CL-MS at T3 | 8 days |
| Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T4 | pre-post changes in urinary metabolites as assessed by CL-MS at T4 | 12 days |
| Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T5 | pre-post changes in urinary metabolites as assessed by CL-MS at T5 | 40 weeks |
| Mass Spectrometry combined with Gas Chromatography (CG-MS) at T1 | pre-post changes in urinary metabolites as assessed by CG-MS at T1 | 1 hour |
| Mass Spectrometry combined with Gas Chromatography (CG-MS) at T2 | pre-post changes in urinary metabolites as assessed by CG-MS at T2 | 4 days |
| Mass Spectrometry combined with Gas Chromatography (CG-MS) at T3 | pre-post changes in urinary metabolites as assessed by CG-MS at T3 | 8 days |
| Mass Spectrometry combined with Gas Chromatography (CG-MS) at T4 | pre-post changes in urinary metabolites as assessed by CG-MS at T4 | 12 days |
| Mass Spectrometry combined with Gas Chromatography (CG-MS) at T5 | pre-post changes in urinary metabolites as assessed by CG-MS at T5 | 40 weeks |
| D000091642 | Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012046 | Rehabilitation |