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| ID | Type | Description | Link |
|---|---|---|---|
| NEO-Plac 01 | Other Identifier | AIOT IRB |
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Results from previous studies suggest the association between Osteopathic Manipulative Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants.
The primary objective of the present study is to evaluate the effectiveness of sham OMT in reducing LOS in a sample of preterm newborns, in order to investigate whether previous clinical results could be related to a hypothetical placebo effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham OMT | Experimental | patients under standard medical care plus sham OMT |
|
| Control | Other | patients under standard medical care plus only osteopathic evaluation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Osteopathic Manipulative Treatment | Other | Patients from this group received sham osteopathic treatments twice a week for the entire length of stay in the unit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of sham OMT in reducing LOS | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| pre-post difference in weight gain | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Cerritelli, DO, MS | European Institute for Evidence Based Osteopathic Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Francesco Cerritelli | Pescara | PE | 65124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23622070 | Background | Cerritelli F, Pizzolorusso G, Ciardelli F, La Mola E, Cozzolino V, Renzetti C, D'Incecco C, Fusilli P, Sabatino G, Barlafante G. Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial. BMC Pediatr. 2013 Apr 26;13:65. doi: 10.1186/1471-2431-13-65. | |
| 21711535 |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| 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 |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard care | Other | Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group. |
|
| 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. |
| D000091642 | Urogenital Diseases |