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

September 15, 2014 updated by: European Institute for Evidence Based Osteopathic Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

225

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

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

5 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: osteopathic manipulative treatment
newborns will receive osteopathic manipulative evaluation and treatment during the entire period of hospitalization plus usual care
Other: usual care
Other: osteopathic manipulative treatment
Other: sham
newborns will receive sham treatment for the entire period of hospitalization plus usual care
Other: usual care
Other: sham therapy
Other: usual care
newborns allocated in the usual care arm will receive standard care only
Other: usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
baseline changes in pain score using Premature Infant Pain Profile
Time Frame: baseline and end of hospitalization, expected hospitalization 4 weeks
baseline and end of hospitalization, expected hospitalization 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of stay in days
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

Other Outcome Measures

Outcome Measure
Time Frame
Neonatal Intensive Care Unit cost
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

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

June 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

September 16, 2014

Last Update Submitted That Met QC Criteria

September 15, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEO-Pa 2

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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Locations

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