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Clinical Trials/NCT02146690
NCT02146690
Unknown
Not Applicable

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

European Institute for Evidence Based Osteopathic Medicine1 site in 1 country225 target enrollmentJune 2014
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ConditionsPrematurity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prematurity
Sponsor
European Institute for Evidence Based Osteopathic Medicine
Enrollment
225
Locations
1
Primary Endpoint
baseline changes in pain score using Premature Infant Pain Profile
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
November 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
European Institute for Evidence Based Osteopathic Medicine
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

baseline changes in pain score using Premature Infant Pain Profile

Time Frame: baseline and end of hospitalization, expected hospitalization 4 weeks

Secondary Outcomes

  • Length of stay in days(participants will be followed for the duration of hospital stay, an expected average of 4 weeks)

Study Sites (1)

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