Premature InfantNCT03833635
Effects of OMT on Premature Physiological Parameters
A study testing osteopathic manipulative treatment in people with Premature Infant and Physiological Stress, run by Come Collaboration at 2 sites in Italy.
Trial summary
Osteopathic manipulative treatment has been showed to reduce LOS in premature infants. Despite the clinical effectiveness, lack of data and information on the physiological underpinning effects during the treatment has been revealed. Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Premature Infant, Physiological Stress
- What is being tested?
- osteopathic manipulative treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 22 Mar 2019to 30 Sep 2019
- 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 Up to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infants
Who cannot join
- congenital/genetic disease
- cardiovascular/neurological disease
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
University of Chieti-Pescara
Chieti, 66100
Francesco Cerritelli, DO, MS, +393394332801, francesco.cerritelli@gmail.com
- Recruiting
Buzzi hospital
Milan, 20154
Andrea Manzotti, PT, DO, +3902 2052 0939, andreamanzotti@soma-osteopatia.it
About this study
Official title: Effects of OMT on Premature Physiological Parameters: a RCT
Osteopathic manipulative treatment has been showed to reduce LOS in premature infants. Despite the clinical effectiveness, lack of data and information on the physiological underpinning effects during the treatment has been revealed. The aim of the study is to explore the immediate physiological effects of osteopathic treatment on premature infants
- Conditions
- Premature Infant, Physiological Stress
- Being tested
- osteopathic manipulative treatment, Sham
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic manipulative treatmentOther
OMT will be used to treat premature infants after having performed a manual osteopathic assessment. Techniques used are indirect
ShamOther
the sham intervention consists in a stable skin-to-skin contact with the participant
| Study group | Role | What they receive |
|---|---|---|
| OMT | Experimental | Not described Receives: Other: osteopathic manipulative treatment |
| Control | Placebo comparator | Not described Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
measure of heart rate
Measured: immediate
Secondary outcomes (1)
oxygen saturation
measure of oxygen
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start22 Mar 2019
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Sep 2019 (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 Premature InfantStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Come Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Vittore Buzzi Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833635
- Sponsor's protocol ID
- COME-01-18
- Status last verified
- Mar 2019
- First submitted
- 6 Feb 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manzotti A, Cerritelli F, Lombardi E, La Rocca S, Chiera M, Galli M, Lista G. Effects of osteopathic treatment versus static touch on heart rate and oxygen saturation in premature babies: A randomized controlled trial. Complement Ther Clin Pract. 2020 May;39:101116. doi: 10.1016/j.ctcp.2020.101116. Epub 2020 Feb 8.
PubMed 32379655
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of OMT on Premature Physiological Parameters: a RCT
- ClinicalTrials.gov ID
- NCT03833635
- Acronym / sponsor ID
- COME-01-18
- Conditions
- Premature Infant, Physiological Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Come CollaborationUniversity, hospital or other
- Collaborators
- Vittore Buzzi Children's Hospital
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 7 Feb 2019 (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.
Osteopathic manipulative treatment has been showed to reduce LOS in premature infants. Despite the clinical effectiveness, lack of data and information on the physiological underpinning effects during the treatment has been revealed. The aim of the study is to explore the immediate physiological effects of osteopathic treatment on premature infants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMT | Experimental | Other: osteopathic manipulative treatment |
| Control | Placebo comparator | Other: Sham |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preterm infants
Key exclusion criteria (2 listed)
- congenital/genetic disease
- cardiovascular/neurological disease
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 treatmentOMT will be used to treat premature infants after having performed a manual osteopathic assessment. Techniques used are indirect | Other | OMT |
| Shamthe sham intervention consists in a stable skin-to-skin contact with the participant | Other | Control |
Primary outcome
heart rate
Time frame: immediate
measure of heart rate
1 secondary outcome
oxygen saturation
Time frame: immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Derived from this study: PubMed 32379655Manzotti A, Cerritelli F, Lombardi E, La Rocca S, Chiera M, Galli M, Lista G. Effects of osteopathic treatment versus static touch on heart rate and oxygen saturation in premature babies: A randomized controlled trial. Complement Ther Clin Pract. 2020 May;39:101116. doi: 10.1016/j.ctcp.2020.101116. Epub 2020 Feb 8.
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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.
2 sites 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 in people with Premature Infant and Physiological Stress, run by Come Collaboration at 2 sites 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 1 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 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate (time frame: immediate). 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 NCT03833635, 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 25 Mar 2019.