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Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy

NCT01852500 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2013-05-13

No results posted yet for this study

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.

Conditions

  • Prematurity

Interventions

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.

OTHER

Standard care

Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

Sponsors & Collaborators

  • European Institute for Evidence Based Osteopathic Medicine

    lead OTHER

Principal Investigators

  • Francesco Cerritelli, DO, MS · European Institute for Evidence Based Osteopathic Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
29 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01852500 on ClinicalTrials.gov