PrematurityNCT02146690
Effect of Osteopathic Manipulative Treatment on Reduction of Pain in Complicated Newborns: RCT
A study testing osteopathic manipulative treatment in people with Prematurity, run by European Institute for Evidence Based Osteopathic Medicine at 1 site in Italy.
Trial summary
The aim of the present 3 armed placebo control parallel group randomized control trial is to explore the extent to which osteopathic manipulative treatment is effective in reducing pain in a population of complicated newborns. Read more about this study
- Who is it for?
- Ages 26 to 40 weeks
- Conditions the study is for
- Prematurity
- What is being tested?
- osteopathic manipulative treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Nov 2015
- 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 26 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- newborns born in the same hospital
- either gender
- diagnosis of any pathological/clinical medical condition
Who cannot join
- lack of guardian consent
- newborn transferred to/from other hospital
- lack of any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Pescara Civil Hospital
Pescara, 65121
Francesco Cerritelli, +393394332801, francesco.cerritelli@ebom.it
About this study
The aim of the present 3 armed placebo control parallel group randomized control trial is to explore the extent to which osteopathic manipulative treatment is effective in reducing pain in a population of complicated newborns.
- Conditions
- Prematurity
- Being tested
- osteopathic manipulative treatment, sham therapy, usual care
- Keywords
- pathology, newborn, osteopathic manipulative treatment, pain
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic manipulative treatmentOther
sham therapyOther
usual careOther
| Study group | Role | What they receive |
|---|---|---|
| osteopathic manipulative treatment | Other | newborns will receive osteopathic manipulative evaluation and treatment during the entire period of hospitalization plus usual care Receives: Other: osteopathic manipulative treatment; Other: usual care |
| sham | Other | newborns will receive sham treatment for the entire period of hospitalization plus usual care Receives: Other: sham therapy; Other: usual care |
| usual care | Other | newborns allocated in the usual care arm will receive standard care only Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
baseline changes in pain score using Premature Infant Pain Profile
Measured: baseline and end of hospitalization, expected hospitalization 4 weeks
Secondary outcomes (1)
Length of stay in days
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute for Evidence Based Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146690
- Sponsor's protocol ID
- NEO-Pa 2
- Status last verified
- Sep 2014
- First submitted
- 20 May 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteopathic Manipulative Treatment on Reduction of Pain in Complicated Newborns: RCT
- ClinicalTrials.gov ID
- NCT02146690
- Acronym / sponsor ID
- NEO-Pa 2
- Conditions
- Prematurity
- Keywords
- pathology, newborn, osteopathic manipulative treatment, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- European Institute for Evidence Based Osteopathic MedicineUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 26 May 2014 (estimated)
- 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.
The aim of the present 3 armed placebo control parallel group randomized control trial is to explore the extent to which osteopathic manipulative treatment is effective in reducing pain in a population of complicated newborns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| osteopathic manipulative treatment | Other | Other: osteopathic manipulative treatment, Other: usual carenewborns will receive osteopathic manipulative evaluation and treatment during the entire period of hospitalization plus usual care |
| sham | Other | Other: sham therapy, Other: usual carenewborns will receive sham treatment for the entire period of hospitalization plus usual care |
| usual care | Other | Other: usual carenewborns allocated in the usual care arm will receive standard care only |
Who may qualify
- Ages
- 26 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- newborns born in the same hospital
- either gender
- diagnosis of any pathological/clinical medical condition
Key exclusion criteria (3 listed)
- lack of guardian consent
- newborn transferred to/from other hospital
- lack of any of the inclusion criteria
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 treatment | Other | osteopathic manipulative treatment |
| sham therapy | Other | sham |
| usual care | Other | osteopathic manipulative treatment, sham, usual care |
Primary outcome
baseline changes in pain score using Premature Infant Pain Profile
Time frame: baseline and end of hospitalization, expected hospitalization 4 weeks
1 secondary outcome
Length of stay in days
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
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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 in people with Prematurity, run by European Institute for Evidence Based Osteopathic Medicine 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 3 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 16 Sep 2014. 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. 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 Francesco Cerritelli (+393394332801, francesco.cerritelli@ebom.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
baseline changes in pain score using Premature Infant Pain Profile (time frame: baseline and end of hospitalization, expected hospitalization 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2014.