Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical Trial
NCT ID: NCT01645137
Last Updated: 2014-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
690 participants
INTERVENTIONAL
2012-07-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OMT
patients under usual medical care plus osteopathic treatment
osteopathic manipulative treatment
Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
control
patients under usual medical care
Usual care
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
Interventions
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osteopathic manipulative treatment
Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
Usual care
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
Eligibility Criteria
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Inclusion Criteria
* osteopathic treatment performed \< 14 days after birth
* preterms born in the same hospital
Exclusion Criteria
* Gestational age \> 37 weeks
* First OMT performed after 14 days from birth
* genetic disorders
* congenital disorders
* cardiovascular abnormalities
* 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)
29 Weeks
37 Weeks
ALL
Yes
Sponsors
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Italian Academy of Traditional Osteopathy - AIOT
OTHER
European Institute for Evidence Based Osteopathic Medicine
OTHER
Responsible Party
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Locations
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Monza Hospital
Monza, Lombardy, Italy
Macerata Hospital
Macerata, The Marches, Italy
Pescara hospital
Pescara, , Italy
Countries
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References
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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.
Cerritelli 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 Links
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Related Info
Related Info
Other Identifiers
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Multi-NE-O
Identifier Type: -
Identifier Source: org_study_id
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