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

Prematurity Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02146690
• Other study ID #: NEO-Pa 2
• Status: Recruiting
• Phase: N/A
• First received: May 20, 2014
• Last updated: September 15, 2014
• Start date: June 2014
• Est. completion date: November 2015

Study information

• Verified date: September 2014
• Source: European Institute for Evidence Based Osteopathic Medicine
• Contact: Francesco Cerritelli
• Phone: +393394332801
• Email: francesco.cerritelli[@]ebom.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 26 Weeks to 40 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prematurity

Intervention

Other:
• osteopathic manipulative treatment

• sham therapy

• usual care

Locations

Country	Name	City	State
Italy	Pescara Civil Hospital	Pescara

Sponsors (1)

Lead Sponsor	Collaborator
European Institute for Evidence Based Osteopathic Medicine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neonatal Intensive Care Unit cost		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Primary	baseline changes in pain score using Premature Infant Pain Profile		baseline and end of hospitalization, expected hospitalization 4 weeks	No
Secondary	Length of stay in days		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No