PrematurityNCT02146677
Effect of Osteopathic Manipulative Treatment on Pain in Preterms
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
Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns. Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs (Cerritelli, 2013) as well as the likelihood of gastrointestinal episodes (Pizzolorusso 2011). Read more about this study
- Who is it for?
- Ages 26 to 37 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
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Sep 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 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infants
- written informed consent by parents or legal guardians
- preterms born in the same hospital
Who cannot join
- Gestational age > 37 weeks
- genetic disorders
- congenital disorders
- cardiovascular abnormalities
- proven or suspected necrotized enterocolitis with or without gastrointestinal perforation
- proven or suspected abdominal obstruction
Show all 13Show fewer
- pre/post surgery patients
- pneumoperitoneum
- atelectasis
- Newborn from an HIV seropositive/drug addicted mother
- respiratory disorders
- transferred to/from other hospital
- admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Pescara Civil Hospital
Pescara, PE, 65100
Francesco Cerritelli, +393394332801, francesco.cerritelli@ebom.it
About this study
Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns. Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs (Cerritelli, 2013) as well as the likelihood of gastrointestinal episodes (Pizzolorusso 2011). Moreover it was reported the absence of adverse events and side effects considering the approach safe (Cerritelli 2013, 2014).
OMT was extensively used to treat, prevent and manage pain symptoms. Numerous research was published addressing acute and chronic pain in different medical conditions. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of OMT in reducing pain in a sample of preterm infants.
- Conditions
- Prematurity
- Being tested
- Osteopathic manipulative treatment, Sham therapy, Usual care
- Keywords
- prematurity, newborns, pain, cost
- 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 |
|---|---|---|
| Sham | Other | newborns will be osteopathically evaluated and softly touched Receives: Other: Sham therapy; Other: Usual care |
| Usual care | Other | newborns will be undergone usual routine neonatology care Receives: Other: Usual care |
| OMT | Other | newborns will receive osteopathic evaluation and treatment according to international guidelines. Osteopathic treatment use will be indirect techniques. Receives: Other: Osteopathic manipulative treatment; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes from baseline in pain using Premature Infant Pain Profile (PIPP)
Measured: baseline and end of hospitalization, average length of hospitalization expected 4 weeks
Secondary outcomes (1)
Number of days of length of stay
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 completionJun 2015 (estimated)
- Study completionSep 2015 (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 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
- 120 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
- NCT02146677
- Sponsor's protocol ID
- NEO-Pa 1
- Status last verified
- Feb 2015
- First submitted
- 20 May 2014
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cerritelli F, Cicchitti L, Martelli M, Barlafante G, Renzetti C, Pizzolorusso G, Lupacchini M, D'Orazio M, Marinelli B, Cozzolino V, Fusilli P, D'Incecco C. Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial. Trials. 2015 Mar 8;16:84. doi: 10.1186/s13063-015-0615-3.
PubMed 25872943
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteopathic Manipulative Treatment on Pain in Preterms
- ClinicalTrials.gov ID
- NCT02146677
- Acronym / sponsor ID
- NEO-Pa 1
- Conditions
- Prematurity
- Keywords
- prematurity, newborns, pain, cost
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- European Institute for Evidence Based Osteopathic MedicineUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Sep 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.
Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns. Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs (Cerritelli, 2013) as well as the likelihood of gastrointestinal episodes (Pizzolorusso 2011). Moreover it was reported the absence of adverse events and side effects considering the approach safe (Cerritelli 2013, 2014).
OMT was extensively used to treat, prevent and manage pain symptoms. Numerous research was published addressing acute and chronic pain in different medical conditions. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of OMT in reducing pain in a sample of preterm infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham | Other | Other: Sham therapy, Other: Usual carenewborns will be osteopathically evaluated and softly touched |
| Usual care | Other | Other: Usual carenewborns will be undergone usual routine neonatology care |
| OMT | Other | Other: Osteopathic manipulative treatment, Other: Usual carenewborns will receive osteopathic evaluation and treatment according to international guidelines. Osteopathic treatment use will be indirect techniques. |
Who may qualify
- Ages
- 26 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- preterm infants
- written informed consent by parents or legal guardians
- preterms born in the same hospital
Key exclusion criteria (13 listed)
- Gestational age > 37 weeks
- genetic disorders
- congenital disorders
- cardiovascular abnormalities
- proven or suspected necrotized enterocolitis with or without gastrointestinal perforation
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 | OMT |
| Sham therapy | Other | Sham |
| Usual care | Other | OMT, Sham, Usual care |
Primary outcome
changes from baseline in pain using Premature Infant Pain Profile (PIPP)
Time frame: baseline and end of hospitalization, average length of hospitalization expected 4 weeks
1 secondary outcome
Number of days of length of stay
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 13 Feb 2015.
- Derived from this study: PubMed 25872943Cerritelli F, Cicchitti L, Martelli M, Barlafante G, Renzetti C, Pizzolorusso G, Lupacchini M, D'Orazio M, Marinelli B, Cozzolino V, Fusilli P, D'Incecco C. Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial. Trials. 2015 Mar 8;16:84. doi: 10.1186/s13063-015-0615-3.
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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 13 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 13 Feb 2015. 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, DO (+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?
changes from baseline in pain using Premature Infant Pain Profile (PIPP) (time frame: baseline and end of hospitalization, average length of hospitalization expected 4 weeks). 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 NCT02146677, 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 13 Feb 2015.