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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham | Other | newborns will be osteopathically evaluated and softly touched |
|
| Usual care | Other | newborns will be undergone usual routine neonatology care |
|
| OMT | Other | newborns will receive osteopathic evaluation and treatment according to international guidelines. Osteopathic treatment use will be indirect techniques. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic manipulative treatment | Other |
| ||
| Sham therapy |
| Measure | Description | Time Frame |
|---|---|---|
| changes from baseline in pain using Premature Infant Pain Profile (PIPP) | baseline and end of hospitalization, average length of hospitalization expected 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days of length of stay | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal intensive care unit cost | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Cerritelli, DO | Contact | +393394332801 | francesco.cerritelli@ebom.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pescara Civil Hospital | Recruiting | Pescara | PE | 65100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25872943 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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|
| Usual care | Other |
|
| D000091642 | Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012046 | Rehabilitation |