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Effect of Osteopathic Manipulative Treatment on Reduction of Pain in Complicated Newborns: RCT

Primary Purpose

Prematurity

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
osteopathic manipulative treatment
sham therapy
usual 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 focused on measuring pathology, newborn, osteopathic manipulative treatment, pain

Eligibility Criteria

26 Weeks - 40 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • newborns born in the same hospital
  • either gender
  • diagnosis of any pathological/clinical medical condition

Exclusion Criteria:

  • lack of guardian consent
  • newborn transferred to/from other hospital
  • lack of any of the inclusion criteria

Sites / Locations

  • Pescara Civil HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

osteopathic manipulative treatment

sham

usual care

Arm Description

newborns will receive osteopathic manipulative evaluation and treatment during the entire period of hospitalization plus usual care

newborns will receive sham treatment for the entire period of hospitalization plus usual care

newborns allocated in the usual care arm will receive standard care only

Outcomes

Primary Outcome Measures

baseline changes in pain score using Premature Infant Pain Profile

Secondary Outcome Measures

Length of stay in days

Full Information

First Posted
May 20, 2014
Last Updated
September 15, 2014
Sponsor
European Institute for Evidence Based Osteopathic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02146690
Brief Title
Effect of Osteopathic Manipulative Treatment on Reduction of Pain in Complicated Newborns: RCT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the present 3 armed placebo control parallel group randomized control trial is to explore the extent to which osteopathic manipulative treatment is effective in reducing pain in a population of complicated newborns.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
pathology, newborn, osteopathic manipulative treatment, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
osteopathic manipulative treatment
Arm Type
Other
Arm Description
newborns will receive osteopathic manipulative evaluation and treatment during the entire period of hospitalization plus usual care
Arm Title
sham
Arm Type
Other
Arm Description
newborns will receive sham treatment for the entire period of hospitalization plus usual care
Arm Title
usual care
Arm Type
Other
Arm Description
newborns allocated in the usual care arm will receive standard care only
Intervention Type
Other
Intervention Name(s)
osteopathic manipulative treatment
Intervention Type
Other
Intervention Name(s)
sham therapy
Intervention Type
Other
Intervention Name(s)
usual care
Primary Outcome Measure Information:
Title
baseline changes in pain score using Premature Infant Pain Profile
Time Frame
baseline and end of hospitalization, expected hospitalization 4 weeks
Secondary Outcome Measure Information:
Title
Length of stay in days
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other Pre-specified Outcome Measures:
Title
Neonatal Intensive Care Unit cost
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
26 Weeks
Maximum Age & Unit of Time
40 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: newborns born in the same hospital either gender diagnosis of any pathological/clinical medical condition Exclusion Criteria: lack of guardian consent newborn transferred to/from other hospital lack of any of the inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Cerritelli
Phone
+393394332801
Email
francesco.cerritelli@ebom.it
Facility Information:
Facility Name
Pescara Civil Hospital
City
Pescara
ZIP/Postal Code
65121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Cerritelli
Phone
+393394332801
Email
francesco.cerritelli@ebom.it

12. IPD Sharing Statement

Learn more about this trial

Effect of Osteopathic Manipulative Treatment on Reduction of Pain in Complicated Newborns: RCT

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