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

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ClinicalTrials.gov Identifier: NCT01645137
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : April 25, 2014
Sponsor:
Collaborator:
Italian Academy of Traditional Osteopathy - AIOT
Information provided by (Responsible Party):
European Institute for Evidence Based Osteopathic Medicine

Tracking Information
First Submitted Date  ICMJE July 15, 2012
First Posted Date  ICMJE July 20, 2012
Last Update Posted Date April 25, 2014
Study Start Date  ICMJE July 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
Number of days of LOS [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical Trial
Official Title  ICMJE Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prematurity
Intervention  ICMJE
  • Other: osteopathic manipulative treatment
    Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
  • Other: Usual care
    Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
Study Arms  ICMJE
  • Experimental: OMT
    patients under usual medical care plus osteopathic treatment
    Intervention: Other: osteopathic manipulative treatment
  • control
    patients under usual medical care
    Intervention: Other: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 19, 2012)
690
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 29 Weeks to 37 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01645137
Other Study ID Numbers  ICMJE Multi-NE-O
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Institute for Evidence Based Osteopathic Medicine
Study Sponsor  ICMJE European Institute for Evidence Based Osteopathic Medicine
Collaborators  ICMJE Italian Academy of Traditional Osteopathy - AIOT
Investigators  ICMJE Not Provided
PRS Account European Institute for Evidence Based Osteopathic Medicine
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP