PrematurityNCT01784835
Early Exposure to OMT Prevents Long LOS
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 application of osteopathic manipulative treatment (OMT) in preterm infants has been demonstrated to be effective in reducing length of stay (LOS). The scope of the present study is to investigate the association between earlier exposure to OMT and reduction of LOS in premature infants Read more about this study
- Who is it for?
- Ages 32 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- What is being tested?
- osteopathic manipulative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2010to Jul 2012
- 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 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- preterm infants born at age between 29 and 37 weeks
- osteopathic treatment performed < 14 days after birth
- preterms born in the same hospital
Who cannot join
- Gestational age < 29 weeks
- Gestational age > 37 weeks
- First OMT performed after 14 days from birth
- genetic disorders
- congenital disorders
- cardiovascular abnormalities
Show all 14Show fewer
- proven or suspected necrotized enterocolitis with or without gastrointestinal perforation proven or suspected abdominal obstruction
- 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.
About this study
The application of osteopathic manipulative treatment (OMT) in preterm infants has been demonstrated to be effective in reducing length of stay (LOS). The scope of the present study is to investigate the association between earlier exposure to OMT and reduction of LOS in premature infants
- Conditions
- Prematurity
- Being tested
- osteopathic manipulative treatment, Usual care
- Keywords
- Osteopathic manipulative treatment, neonatology, neonatal care, prematurity, complementary and alternative medicine, length of stay
- 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
Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
Usual careOther
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
| Study group | Role | What they receive |
|---|---|---|
| control | Other | patients under standard medical care Receives: Other: Usual care |
| OMT | Experimental | patients under usual medical care plus osteopathic treatment Receives: Other: osteopathic manipulative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days of LOS
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes (1)
effectiveness of OMT considering different lag time between birth and the first OMT
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 posted6 Feb 2013 (estimated)
- Study startOct 2010
- Primary completionJul 2012
- Study completionJul 2012
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 113 participants (actual)
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
- NCT01784835
- Sponsor's protocol ID
- NEO-02
- Status last verified
- Feb 2013
- First submitted
- 4 Feb 2013
- Last updated
- 6 Feb 2013
- Results posted
- No
Publications
Pizzolorusso G, Turi P, Barlafante G, Cerritelli F, Renzetti C, Cozzolino V, D'Orazio M, Fusilli P, Carinci F, D'Incecco C. Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study. Chiropr Man Therap. 2011 Jun 28;19(1):15. doi: 10.1186/2045-709X-19-15.
PubMed 21711535
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Exposure to OMT Prevents Long LOS
- ClinicalTrials.gov ID
- NCT01784835
- Acronym / sponsor ID
- NEO-02
- Conditions
- Prematurity
- Keywords
- Osteopathic manipulative treatment, neonatology, neonatal care, prematurity, complementary and alternative medicine, length of stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- European Institute for Evidence Based Osteopathic MedicineUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 6 Feb 2013 (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 application of osteopathic manipulative treatment (OMT) in preterm infants has been demonstrated to be effective in reducing length of stay (LOS). The scope of the present study is to investigate the association between earlier exposure to OMT and reduction of LOS in 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 |
|---|---|---|
| control | Other | Other: Usual carepatients under standard medical care |
| OMT | Experimental | Other: osteopathic manipulative treatmentpatients under usual medical care plus osteopathic treatment |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- preterm infants born at age between 29 and 37 weeks
- osteopathic treatment performed < 14 days after birth
- preterms born in the same hospital
Key exclusion criteria (14 listed)
- Gestational age < 29 weeks
- Gestational age > 37 weeks
- First OMT performed after 14 days from birth
- genetic disorders
- congenital disorders
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 treatmentPatients from this group received osteopathic treatments twice a week for the entire length of stay in the unit. | Other | OMT |
| Usual carePatients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group. | Other | control |
Primary outcome
Number of days of LOS
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
1 secondary outcome
effectiveness of OMT considering different lag time between birth and the first OMT
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
- Background: PubMed 21711535Pizzolorusso G, Turi P, Barlafante G, Cerritelli F, Renzetti C, Cozzolino V, D'Orazio M, Fusilli P, Carinci F, D'Incecco C. Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study. Chiropr Man Therap. 2011 Jun 28;19(1):15. doi: 10.1186/2045-709X-19-15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 14 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: finished, as of the sponsor's last update on 6 Feb 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days of LOS (time frame: participants will be followed for the duration of hospital stay, an expected average of 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 NCT01784835, 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 6 Feb 2013.