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Early Exposure to OMT Prevents Long LOS

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ClinicalTrials.gov Identifier: NCT01784835
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : February 6, 2013
Sponsor:
Information provided by (Responsible Party):
European Institute for Evidence Based Osteopathic Medicine

Brief Summary:
The application of osteopathic manipulative treatment (OMT) in preterm infants has been demonstrated to be effective in reducing length of stay (LOS). The scope of the present study is to investigate the association between earlier exposure to OMT and reduction of LOS in premature infants

Condition or disease Intervention/treatment Phase
Prematurity Other: osteopathic manipulative treatment Other: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
control
patients under standard 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.

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.




Primary Outcome Measures :
  1. 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 :
  1. effectiveness of OMT considering different lag time between birth and the first OMT [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]


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Ages Eligible for Study:   32 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)

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): NCT01784835


Locations
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Italy
Macerata Hospital
Macerata, Italy, 62100
Sponsors and Collaborators
European Institute for Evidence Based Osteopathic Medicine

Publications:
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Responsible Party: European Institute for Evidence Based Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT01784835     History of Changes
Other Study ID Numbers: NEO-02
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: February 2013
Keywords provided by European Institute for Evidence Based Osteopathic Medicine:
Osteopathic manipulative treatment
neonatology
neonatal care
prematurity
complementary and alternative medicine
length of stay
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications