Effects of OMT on Premature Physiological Parameters

NCT ID: NCT03833635

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-22

Study Completion Date

2019-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Premature Infant Physiological Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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OMT

Group Type EXPERIMENTAL

osteopathic manipulative treatment

Intervention Type OTHER

OMT will be used to treat premature infants after having performed a manual osteopathic assessment. Techniques used are indirect

Control

Group Type PLACEBO_COMPARATOR

Sham

Intervention Type OTHER

the sham intervention consists in a stable skin-to-skin contact with the participant

Interventions

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osteopathic manipulative treatment

OMT will be used to treat premature infants after having performed a manual osteopathic assessment. Techniques used are indirect

Intervention Type OTHER

Sham

the sham intervention consists in a stable skin-to-skin contact with the participant

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* preterm infants

Exclusion Criteria

* congenital/genetic disease
* cardiovascular/neurological disease
Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vittore Buzzi Children's Hospital

OTHER

Sponsor Role collaborator

Come Collaboration

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Chieti-Pescara

Chieti, , Italy

Site Status RECRUITING

Buzzi hospital

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Francesco Cerritelli, DO, MS

Role: primary

+393394332801

Andrea Manzotti, PT, DO

Role: primary

+3902 2052 0939

References

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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.

Reference Type DERIVED
PMID: 32379655 (View on PubMed)

Other Identifiers

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COME-01-18

Identifier Type: -

Identifier Source: org_study_id

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