Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical Trial

April 24, 2014 updated by: European Institute for Evidence Based Osteopathic Medicine

Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial

The use of complementary and alternative medicine in neonatal ward has been steadily rising during the last decade. This integrated medicine approach has been shown to be helpful to improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to premature infants to reduce the length of stay and to cope with clinical complications. Results from previous studies documented the positive association between OMT and shorter period of hospitalisation as well as improvement of clinical conditions. The aim of this nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in premature infants across 3 neonatal intensive care units (NICU).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

690

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pescara, Italy, 65121
        • Pescara hospital
    • Lombardia
      • Monza, Lombardia, Italy, 20052
        • Monza Hospital
    • Marche
      • Macerata, Marche, Italy, 62100
        • Macerata Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • preterm infants born at age between 29 and 37 weeks
  • osteopathic treatment performed < 14 days after birth
  • preterms born in the same hospital

Exclusion Criteria:

  • Gestational age < 29 weeks
  • Gestational age > 37 weeks
  • First OMT performed after 14 days from birth
  • genetic disorders
  • congenital disorders
  • cardiovascular abnormalities
  • proven or suspected necrotized enterocolitis with or without gastrointestinal perforation
  • proven or suspected abdominal obstruction
  • pre/post surgery patients
  • pneumoperitoneum
  • atelectasis
  • Newborn from an HIV seropositive/drug addicted mother
  • respiratory disorders
  • transferred to/from other hospital
  • admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OMT
patients under usual medical care plus osteopathic treatment
Other: osteopathic manipulative treatment
Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
Other: control
patients under usual medical care
Other: Usual care
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of days of LOS
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
pre-post difference in weight gain
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
number of episodes of vomit
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
days to full enteral feeding
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
NICU costs
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
number of episodes of regurgitation
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
number of episodes of stooling
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute for Evidence Based Osteopathic Medicine

Collaborators

Italian Academy of Traditional Osteopathy - AIOT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 15, 2012

First Submitted That Met QC Criteria

July 19, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Multi-NE-O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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