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

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 prematurity, OMT, complementary and alternative medicine, neonates, length of stay

Eligibility Criteria

29 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

  • Monza Hospital
  • Macerata Hospital
  • Pescara hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

OMT

control

Arm Description

patients under usual medical care plus osteopathic treatment

patients under usual medical care

Outcomes

Primary Outcome Measures

Number of days of LOS

Secondary Outcome Measures

pre-post difference in weight gain
number of episodes of vomit
days to full enteral feeding
NICU costs
number of episodes of regurgitation
number of episodes of stooling

Full Information

First Posted
July 15, 2012
Last Updated
April 24, 2014
Sponsor
European Institute for Evidence Based Osteopathic Medicine
Collaborators
Italian Academy of Traditional Osteopathy - AIOT
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1. Study Identification

Unique Protocol Identification Number
NCT01645137
Brief Title
Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical Trial
Official Title
Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Institute for Evidence Based Osteopathic Medicine
Collaborators
Italian Academy of Traditional Osteopathy - AIOT

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
prematurity, OMT, complementary and alternative medicine, neonates, length of stay

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
690 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OMT
Arm Type
Experimental
Arm Description
patients under usual medical care plus osteopathic treatment
Arm Title
control
Arm Type
Other
Arm Description
patients under usual medical care
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
pre-post difference in weight gain
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
number of episodes of vomit
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
days to full enteral feeding
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
NICU costs
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
number of episodes of regurgitation
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
number of episodes of stooling
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
29 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
Monza Hospital
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20052
Country
Italy
Facility Name
Macerata Hospital
City
Macerata
State/Province
Marche
ZIP/Postal Code
62100
Country
Italy
Facility Name
Pescara hospital
City
Pescara
ZIP/Postal Code
65121
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25974071
Citation
Cerritelli F, Pizzolorusso G, Renzetti C, Cozzolino V, D'Orazio M, Lupacchini M, Marinelli B, Accorsi A, Lucci C, Lancellotti J, Ballabio S, Castelli C, Molteni D, Besana R, Tubaldi L, Perri FP, Fusilli P, D'Incecco C, Barlafante G. A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms. PLoS One. 2015 May 14;10(5):e0127370. doi: 10.1371/journal.pone.0127370. eCollection 2015.
Results Reference
derived
PubMed Identifier
23430598
Citation
Cerritelli F, Pizzolorusso G, Renzetti C, D'Incecco C, Fusilli P, Perri PF, Tubaldi L, Barlafante G. Effectiveness of osteopathic manipulative treatment in neonatal intensive care units: protocol for a multicentre randomised clinical trial. BMJ Open. 2013 Feb 20;3(2):e002187. doi: 10.1136/bmjopen-2012-002187. Print 2013.
Results Reference
derived
Links:
URL
http://www.ebom.it
Description
Related Info
URL
http://www.aiot.edu
Description
Related Info

Learn more about this trial

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

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