PretermNCT05853991
Effects of Touch on Brain Connectivity and Metabolic Biomarkers in Preterm Infants
A study testing osteopathic manipulative treatment and Active comparator in people with Preterm and Infant ALL, run by Come Collaboration at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 32 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm, Infant ALL, Premature
- What is being tested?
- osteopathic manipulative treatment and Active comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2023to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Ospedale dei bambini "Vittore Buzzi"
Milan
Gianluca Lista, PhD, +390257995801, gianluca.lista@asst-fbf-sacco.it
About this study
Official title: Effects of Affective Touch, Therapeutic Touch (OMT), and Static/Nonspecific Touch on Brain Connectivity and Metabolic Biomarkers in Preterm Infants
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.
Read more
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).
- Conditions
- Preterm, Infant ALL, Premature, Disease
- Being tested
- osteopathic manipulative treatment, Active comparator, Placebo
- Medical subject headings
- Premature Birth, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic manipulative treatmentOther
The intervention will be based on the specific assessment and treatment of the preterm developed by the team and validated through different studies.
Active comparatorOther
Application of affective touch
PlaceboOther
Application of static touch
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: osteopathic manipulative treatment |
| Affective touch | Active comparator | Participants will receive an affective touch intervention following the standardised procedure for affective touch Receives: Other: Active comparator |
| Static touch | Placebo comparator | Participants will receive a static touch intervention following the standardised procedure for static touch Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain changes
pre-post changes in BOLD levels among different brain areas
Measured: 1 hour
Secondary outcomes (16)
electroencephalogram (EEG) changes
pre-post changes from baseline in the EEG power in slow delta waves band at the end of the treatment period
Measured: 10 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T1
pre-post changes in urinary metabolites as assessed by 1H NMR at T1
Measured: 1 hour
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T2
pre-post changes in urinary metabolites as assessed by 1H NMR at T2
Measured: 4 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T3
pre-post changes in urinary metabolites as assessed by 1H NMR at T3
Measured: 8 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T4
pre-post changes in urinary metabolites as assessed by 1H NMR at T4
Measured: 12 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T5
pre-post changes in urinary metabolites as assessed by 1H NMR at T5
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study startJun 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Come Collaboration
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853991
- Sponsor's protocol ID
- COME-23-01
- Status last verified
- May 2023
- First submitted
- 7 Feb 2023
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41145247
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Affective Touch, Therapeutic Touch (OMT), and Static/Nonspecific Touch on Brain Connectivity and Metabolic Biomarkers in Preterm Infants
- ClinicalTrials.gov ID
- NCT05853991
- Acronym / sponsor ID
- COME-23-01
- Conditions
- Preterm, Infant ALL, Premature, Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Come CollaborationUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapeutic touch | Experimental | Other: osteopathic manipulative treatmentThe 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 | Other: Active comparatorParticipants will receive an affective touch intervention following the standardised procedure for affective touch |
| Static touch | Placebo comparator | Other: PlaceboParticipants will receive a static touch intervention following the standardised procedure for static touch |
Who may qualify
- Ages
- 32 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| osteopathic manipulative treatmentThe intervention will be based on the specific assessment and treatment of the preterm developed by the team and validated through different studies. | Other | Therapeutic touch |
| Active comparatorApplication of affective touch | Other | Affective touch |
| PlaceboApplication of static touch | Other | Static touch |
Primary outcome
brain changes
Time frame: 1 hour
pre-post changes in BOLD levels among different brain areas
16 secondary outcomes
electroencephalogram (EEG) changes
Time frame: 10 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T1
Time frame: 1 hour
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T2
Time frame: 4 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T3
Time frame: 8 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T4
Time frame: 12 days
Proton Nuclear Magnetic Resonance Spectroscopy (1H NMR) at T5
Time frame: 40 weeks
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T1
Time frame: 1 hour
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T2
Time frame: 4 days
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T3
Time frame: 8 days
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T4
Time frame: 12 days
Mass Spectrometry combined with Liquid Chromatography (CL-MS)at T5
Time frame: 40 weeks
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T1
Time frame: 1 hour
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T2
Time frame: 4 days
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T3
Time frame: 8 days
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T4
Time frame: 12 days
Mass Spectrometry combined with Gas Chromatography (CG-MS) at T5
Time frame: 40 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 41145247Manzotti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopathic manipulative treatment and Active comparator in people with Preterm and Infant ALL, run by Come Collaboration at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Manzotti (+393484044783, manzotti.andrea68@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain changes (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05853991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.