PrematurityNCT01645137
Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical Trial
A study testing osteopathic manipulative treatment in people with Prematurity, run by European Institute for Evidence Based Osteopathic Medicine at 3 sites in Italy.
Trial summary
The use of complementary and alternative medicine in neonatal ward has been steadily rising during the last decade. This integrated medicine approach has been shown to be helpful to improve neonatal health care. Read more about this study
- Who is it for?
- Ages 29 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
- 690 participants
- Where
- 3 sitesItaly
- Study dates
- Jul 2012to Oct 2013
- 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 29 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 15Show 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
3 sites in 1 country.
Italy3 sites
Monza Hospital
Monza, Lombardy, 20052
Pescara hospital
Pescara, 65121
Macerata Hospital
Province of Macerata, The Marches, 62100
About this study
Official title: Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial
The use of complementary and alternative medicine in neonatal ward has been steadily rising during the last decade. This integrated medicine approach has been shown to be helpful to improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to premature infants to reduce the length of stay and to cope with clinical complications. Results from previous studies documented the positive association between OMT and shorter period of hospitalisation as well as improvement of clinical conditions. The aim of this nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in premature infants across 3 neonatal intensive care units (NICU).
- Conditions
- Prematurity
- Being tested
- osteopathic manipulative treatment, Usual care
- Keywords
- prematurity, OMT, complementary and alternative medicine, neonates, 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 |
|---|---|---|
| OMT | Experimental | patients under usual medical care plus osteopathic treatment Receives: Other: osteopathic manipulative treatment |
| control | Other | patients under usual medical care Receives: Other: Usual care |
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 (6)
pre-post difference in weight gain
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
number of episodes of vomit
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
days to full enteral feeding
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
NICU costs
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
number of episodes of regurgitation
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
number of episodes of stooling
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 posted20 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute for Evidence Based Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Academy of Traditional Osteopathy - AIOT
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645137
- Sponsor's protocol ID
- Multi-NE-O
- Status last verified
- Apr 2014
- First submitted
- 15 Jul 2012
- Last updated
- 25 Apr 2014
- Results posted
- No
Publications
Cerritelli F, Pizzolorusso G, Renzetti C, Cozzolino V, D'Orazio M, Lupacchini M, Marinelli B, Accorsi A, Lucci C, Lancellotti J, Ballabio S, Castelli C, Molteni D, Besana R, Tubaldi L, Perri FP, Fusilli P, D'Incecco C, Barlafante G. A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms. PLoS One. 2015 May 14;10(5):e0127370. doi: 10.1371/journal.pone.0127370. eCollection 2015.
PubMed 25974071Cerritelli F, Pizzolorusso G, Renzetti C, D'Incecco C, Fusilli P, Perri PF, Tubaldi L, Barlafante G. Effectiveness of osteopathic manipulative treatment in neonatal intensive care units: protocol for a multicentre randomised clinical trial. BMJ Open. 2013 Feb 20;3(2):e002187. doi: 10.1136/bmjopen-2012-002187. Print 2013.
PubMed 23430598
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01645137
- Acronym / sponsor ID
- Multi-NE-O
- Conditions
- Prematurity
- Keywords
- prematurity, OMT, complementary and alternative medicine, neonates, length of stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- European Institute for Evidence Based Osteopathic MedicineUniversity, hospital or other
- Collaborators
- Italian Academy of Traditional Osteopathy - AIOT
- Study start
- Jul 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 Jul 2012 (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 use of complementary and alternative medicine in neonatal ward has been steadily rising during the last decade. This integrated medicine approach has been shown to be helpful to improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to premature infants to reduce the length of stay and to cope with clinical complications. Results from previous studies documented the positive association between OMT and shorter period of hospitalisation as well as improvement of clinical conditions. The aim of this nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in premature infants across 3 neonatal intensive care units (NICU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMT | Experimental | Other: osteopathic manipulative treatmentpatients under usual medical care plus osteopathic treatment |
| control | Other | Other: Usual carepatients under usual medical care |
Who may qualify
- Ages
- 29 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 (15 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
6 secondary outcomes
pre-post difference in weight gain
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
number of episodes of vomit
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
days to full enteral feeding
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
NICU costs
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
number of episodes of regurgitation
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
number of episodes of stooling
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 25 Apr 2014.
- Derived from this study: PubMed 25974071Cerritelli F, Pizzolorusso G, Renzetti C, Cozzolino V, D'Orazio M, Lupacchini M, Marinelli B, Accorsi A, Lucci C, Lancellotti J, Ballabio S, Castelli C, Molteni D, Besana R, Tubaldi L, Perri FP, Fusilli P, D'Incecco C, Barlafante G. A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms. PLoS One. 2015 May 14;10(5):e0127370. doi: 10.1371/journal.pone.0127370. eCollection 2015.
- Derived from this study: PubMed 23430598Cerritelli F, Pizzolorusso G, Renzetti C, D'Incecco C, Fusilli P, Perri PF, Tubaldi L, Barlafante G. Effectiveness of osteopathic manipulative treatment in neonatal intensive care units: protocol for a multicentre randomised clinical trial. BMJ Open. 2013 Feb 20;3(2):e002187. doi: 10.1136/bmjopen-2012-002187. Print 2013.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Prematurity
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
3 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 Prematurity, run by European Institute for Evidence Based Osteopathic Medicine at 3 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 3 inclusion and 15 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 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 NCT01645137, which also lists 2 linked publications.
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 Apr 2014.