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

May 9, 2013 updated by: European Institute for Evidence Based Osteopathic Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PE
      • Pescara, PE, Italy, 65124
        • Francesco Cerritelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
pre-post difference in weight gain
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute for Evidence Based Osteopathic Medicine

Investigators

  • Study Chair: Francesco Cerritelli, DO, MS, European Institute for Evidence Based Osteopathic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

May 9, 2013

First Submitted That Met QC Criteria

May 9, 2013

First Posted (Estimate)

May 13, 2013

Study Record Updates

Last Update Posted (Estimate)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEO-Plac 01 (Other Identifier: AIOT IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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