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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01645137
First Posted: July 20, 2012
Last Update Posted: April 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Accademia Italiana Osteopatia Tradizionale
Information provided by (Responsible Party):
European Institute for Evidence Based Osteopathic Medicine
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial

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 ]

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 ]
  • number of episodes of vomit [ Time Frame: 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 ]
  • NICU costs [ Time Frame: 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 ]
  • number of episodes of stooling [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]

Estimated Enrollment: 690
Study Start Date: July 2012
Study Completion Date: October 2013
Primary Completion Date: September 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

Information from the National Library of Medicine

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Ages Eligible for Study:   29 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645137


Locations
Italy
Monza Hospital
Monza, Lombardia, Italy, 20052
Macerata Hospital
Macerata, Marche, Italy, 62100
Pescara hospital
Pescara, Italy, 65121
Sponsors and Collaborators
European Institute for Evidence Based Osteopathic Medicine
Accademia Italiana Osteopatia Tradizionale
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: European Institute for Evidence Based Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT01645137     History of Changes
Other Study ID Numbers: Multi-NE-O
First Submitted: July 15, 2012
First Posted: July 20, 2012
Last Update Posted: April 25, 2014
Last Verified: April 2014

Keywords provided by European Institute for Evidence Based Osteopathic Medicine:
prematurity
OMT
complementary and alternative medicine
neonates
length of stay

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications