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

This study is currently recruiting participants.

Verified February 2013 by European Institute for Evidence Based Osteopathic Medicine

Sponsor:

Collaborator:

Accademia Italiana Osteopatia Tradizionale

Information provided by (Responsible Party):

European Institute for Evidence Based Osteopathic Medicine

ClinicalTrials.gov Identifier:

NCT01645137

First received: July 15, 2012

Last updated: February 4, 2013

Last verified: February 2013

History of Changes

Purpose

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).

Condition	Intervention
Prematurity	Other: osteopathic manipulative treatment Other: Usual care

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies

U.S. FDA Resources

Further study details as provided by European Institute for Evidence Based Osteopathic Medicine:

Primary Outcome Measures:

Number of days of LOS [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pre-post difference in weight gain [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
number of episodes of vomit [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
days to full enteral feeding [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
NICU costs [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
number of episodes of regurgitation [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
number of episodes of stooling [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	690
Study Start Date:	July 2012
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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.

Eligibility

Ages Eligible for Study:	29 Weeks to 37 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01645137

Contacts

Contact: Francesco Cerritelli, DO, MS

+393394332801

francesco.cerritelli@ebom.it

Locations

Italy
Monza Hospital	Recruiting
Monza, Lombardia, Italy, 20052
Macerata Hospital	Recruiting
Macerata, Marche, Italy, 62100
Sub-Investigator: Alessandro Accorsi, DO, BSN
Pescara hospital	Recruiting
Pescara, Italy, 65121
Principal Investigator: Francesco Cerritelli, DO, MS

Sponsors and Collaborators

European Institute for Evidence Based Osteopathic Medicine

Accademia Italiana Osteopatia Tradizionale

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	European Institute for Evidence Based Osteopathic Medicine
ClinicalTrials.gov Identifier:	NCT01645137 History of Changes
Other Study ID Numbers:	Multi-NE-O
Study First Received:	July 15, 2012
Last Updated:	February 4, 2013
Health Authority:	Italy: Ethics Committee

Keywords provided by European Institute for Evidence Based Osteopathic Medicine:

prematurity
OMT
complementary and alternative medicine
neonates
length of stay

ClinicalTrials.gov processed this record on May 23, 2013

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