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

Not Applicable

• Conditions: Prematurity

• Registration Number: NCT02146690
• Lead Sponsor: European Institute for Evidence Based Osteopathic Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-26
• Study Start: 2014-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-16
• Primary Completion: 2015-08
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
baseline changes in pain score using Premature Infant Pain Profile	baseline and end of hospitalization, expected hospitalization 4 weeks

Secondary Outcome Measures

Name	Time	Method
Length of stay in days	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Trial Locations

Locations (1)

Pescara Civil Hospital; 🇮🇹 Pescara, Italy