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Early Exposure to OMT Prevents Long LOS

Primary Purpose

Prematurity

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
osteopathic manipulative treatment
Usual care
Sponsored by
European Institute for Evidence Based Osteopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prematurity focused on measuring Osteopathic manipulative treatment, neonatology, neonatal care, prematurity, complementary and alternative medicine, length of stay

Eligibility Criteria

32 Weeks - 37 Weeks (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Macerata Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control

OMT

Arm Description

patients under standard medical care

patients under usual medical care plus osteopathic treatment

Outcomes

Primary Outcome Measures

Number of days of LOS

Secondary Outcome Measures

effectiveness of OMT considering different lag time between birth and the first OMT

Full Information

First Posted
February 4, 2013
Last Updated
February 4, 2013
Sponsor
European Institute for Evidence Based Osteopathic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01784835
Brief Title
Early Exposure to OMT Prevents Long LOS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Institute for Evidence Based Osteopathic Medicine

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
Osteopathic manipulative treatment, neonatology, neonatal care, prematurity, complementary and alternative medicine, length of stay

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Other
Arm Description
patients under standard medical care
Arm Title
OMT
Arm Type
Experimental
Arm Description
patients under usual medical care plus osteopathic treatment
Intervention Type
Other
Intervention Name(s)
osteopathic manipulative treatment
Intervention Description
Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Macerata Hospital
City
Macerata
ZIP/Postal Code
62100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21711535
Citation
Pizzolorusso G, Turi P, Barlafante G, Cerritelli F, Renzetti C, Cozzolino V, D'Orazio M, Fusilli P, Carinci F, D'Incecco C. Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study. Chiropr Man Therap. 2011 Jun 28;19(1):15. doi: 10.1186/2045-709X-19-15.
Results Reference
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Early Exposure to OMT Prevents Long LOS

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