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Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms

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ClinicalTrials.gov Identifier: NCT01544257
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : March 5, 2012
Sponsor:
Information provided by (Responsible Party):
European Institute for Evidence Based Osteopathic Medicine

Study Description
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Brief Summary:
The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvement in several clinical outcomes. The aim of the present study is to show the effect of OMT on LOS in a sample of premature infants.

Condition or disease Intervention/treatment Phase
Prematurity Other: osteopathic manipulative treatment Procedure: Usual care Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of OMT on Length of Stay in a Population of Preterm Infants: RCT Study
Study Start Date : August 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: OMT
patients under standard medical care plus OMT.
 Other: osteopathic manipulative treatment
Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
No Intervention: Control
patients under standard medical care plus only osteopathic evaluation
 Procedure: Usual care
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.


Outcome Measures
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Primary Outcome Measures :
  1. evaluate the effectiveness of OMT in reducing LOS [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]

Secondary Outcome Measures :
  1. pre-post difference in weight gain [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]

Eligibility Criteria
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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, > 37 weeks;
  • osteopathic treatment performed > 14 days after birth;
  • newborn transferred to/from other hospital;
  • newborn from to HIV seropositive and/or drug addict mother;
  • newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.
Contacts and Locations
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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): NCT01544257


Locations
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Italy
Francesco Cerritelli
Pescara, Italy, 65124
Sponsors and Collaborators
European Institute for Evidence Based Osteopathic Medicine
Investigators
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Study Chair: Francesco Cerritelli, DO, MS European Institute for Evidence Based Osteopathic Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: European Institute for Evidence Based Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT01544257    
Other Study ID Numbers: NEO-01
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: February 2012
Keywords provided by European Institute for Evidence Based Osteopathic Medicine:
Osteopathic manipulative treatment
alternative medicine
complementary medicine
neonatology
 neonatal care
prematurity
allied health care
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications