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NCT03833635 Clinical Trial

Effects of OMT on Premature Physiological Parameters

Premature Infant Clinical Trial

Official title:
Effects of OMT on Premature Physiological Parameters: a RCT

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03833635
Other study ID # COME-01-18
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 22, 2019
Est. completion date September 30, 2019

Study information
Verified date March 2019
Source Come Collaboration
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Osteopathic manipulative treatment has been showed to reduce LOS in premature infants. Despite the clinical effectiveness, lack of data and information on the physiological underpinning effects during the treatment has been revealed. The aim of the study is to explore the immediate physiological effects of osteopathic treatment on premature infants

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date September 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Months
Eligibility Inclusion Criteria:

- preterm infants

Exclusion Criteria:

- congenital/genetic disease

- cardiovascular/neurological disease

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• osteopathic manipulative treatment
OMT will be used to treat premature infants after having performed a manual osteopathic assessment. Techniques used are indirect
• Sham
the sham intervention consists in a stable skin-to-skin contact with the participant

Locations
Country Name City State
Italy University of Chieti-Pescara Chieti
Italy Buzzi hospital Milan

Sponsors (2)
Lead Sponsor Collaborator
Come Collaboration Vittore Buzzi Children's Hospital

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary heart rate measure of heart rate immediate
Secondary oxygen saturation measure of oxygen immediate
See also
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