search
Back to results

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

Primary Purpose

Prematurity

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Sham Osteopathic Manipulative Treatment
Standard care
Sponsored by
European Institute for Evidence Based Osteopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prematurity

Eligibility Criteria

29 Weeks - 37 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Francesco Cerritelli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Sham OMT

Control

Arm Description

patients under standard medical care plus sham OMT

patients under standard medical care plus only osteopathic evaluation

Outcomes

Primary Outcome Measures

Evaluate the effectiveness of sham OMT in reducing LOS

Secondary Outcome Measures

pre-post difference in weight gain

Full Information

First Posted
May 9, 2013
Last Updated
May 9, 2013
Sponsor
European Institute for Evidence Based Osteopathic Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT01852500
Brief Title
Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Institute for Evidence Based Osteopathic Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham OMT
Arm Type
Experimental
Arm Description
patients under standard medical care plus sham OMT
Arm Title
Control
Arm Type
Other
Arm Description
patients under standard medical care plus only osteopathic evaluation
Intervention Type
Other
Intervention Name(s)
Sham Osteopathic Manipulative Treatment
Intervention Description
Patients from this group received sham osteopathic treatments twice a week for the entire length of stay in the unit.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
pre-post difference in weight gain
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Cerritelli, DO, MS
Organizational Affiliation
European Institute for Evidence Based Osteopathic Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Francesco Cerritelli
City
Pescara
State/Province
PE
ZIP/Postal Code
65124
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
23622070
Citation
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.
Results Reference
background
PubMed Identifier
21711535
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs