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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
Sponsor:
Information provided by (Responsible Party):
European Institute for Evidence Based Osteopathic Medicine

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
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.

Control
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. pre-post difference in weight gain [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]


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Ages Eligible for Study:   29 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • preterm infants born at age between 29 and 37 weeks
  • sham osteopathic treatment performed < 14 days after birth
  • preterm infants born in the same hospital

Exclusion Criteria:

  • gestational age < 29, > 37 weeks;
  • sham osteopathic treatment performed > 14 days after birth;
  • newborn transferred to/from other hospital;
  • newborn from to HIV seropositive and/or drug addict mother;
  • newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.

Information from the National Library of Medicine

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


Locations
Italy
Francesco Cerritelli
Pescara, PE, Italy, 65124
Sponsors and Collaborators
European Institute for Evidence Based Osteopathic Medicine
Investigators
Study Chair: Francesco Cerritelli, DO, MS European Institute for Evidence Based Osteopathic Medicine