Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy
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|ClinicalTrials.gov Identifier: NCT01852500|
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : May 13, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prematurity||Other: Sham Osteopathic Manipulative Treatment Other: Standard care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Experimental: Sham OMT
patients under standard medical care plus sham OMT
Other: Sham Osteopathic Manipulative Treatment
Patients from this group received sham osteopathic treatments twice a week for the entire length of stay in the unit.
patients under standard medical care plus only osteopathic evaluation
Other: Standard care
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
- Evaluate the effectiveness of sham OMT in reducing LOS [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
- pre-post difference in weight gain [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852500
|Pescara, PE, Italy, 65124|
|Study Chair:||Francesco Cerritelli, DO, MS||European Institute for Evidence Based Osteopathic Medicine|