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Effects of OMT on Premature Physiological Parameters

Primary Purpose

Premature Infant, Physiological Stress

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
osteopathic manipulative treatment
Sham
Sponsored by
Come Collaboration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Infant

Eligibility Criteria

undefined - 2 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • preterm infants

Exclusion Criteria:

  • congenital/genetic disease
  • cardiovascular/neurological disease

Sites / Locations

  • University of Chieti-PescaraRecruiting
  • Buzzi hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OMT

Control

Arm Description

Outcomes

Primary Outcome Measures

heart rate
measure of heart rate

Secondary Outcome Measures

oxygen saturation
measure of oxygen

Full Information

First Posted
February 6, 2019
Last Updated
March 21, 2019
Sponsor
Come Collaboration
Collaborators
Vittore Buzzi Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03833635
Brief Title
Effects of OMT on Premature Physiological Parameters
Official Title
Effects of OMT on Premature Physiological Parameters: a RCT
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Come Collaboration
Collaborators
Vittore Buzzi Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant, Physiological Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OMT
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
osteopathic manipulative treatment
Intervention Description
OMT will be used to treat premature infants after having performed a manual osteopathic assessment. Techniques used are indirect
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
the sham intervention consists in a stable skin-to-skin contact with the participant
Primary Outcome Measure Information:
Title
heart rate
Description
measure of heart rate
Time Frame
immediate
Secondary Outcome Measure Information:
Title
oxygen saturation
Description
measure of oxygen
Time Frame
immediate

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: preterm infants Exclusion Criteria: congenital/genetic disease cardiovascular/neurological disease
Facility Information:
Facility Name
University of Chieti-Pescara
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Cerritelli, DO, MS
Phone
+393394332801
Email
francesco.cerritelli@gmail.com
Facility Name
Buzzi hospital
City
Milan
ZIP/Postal Code
20154
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Manzotti, PT, DO
Phone
+3902 2052 0939
Email
andreamanzotti@soma-osteopatia.it

12. IPD Sharing Statement

Citations:
PubMed Identifier
32379655
Citation
Manzotti A, Cerritelli F, Lombardi E, La Rocca S, Chiera M, Galli M, Lista G. Effects of osteopathic treatment versus static touch on heart rate and oxygen saturation in premature babies: A randomized controlled trial. Complement Ther Clin Pract. 2020 May;39:101116. doi: 10.1016/j.ctcp.2020.101116. Epub 2020 Feb 8.
Results Reference
derived

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Effects of OMT on Premature Physiological Parameters

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