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Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms

Primary Purpose

Prematurity

Status
Completed
Phase
Phase 4
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, alternative medicine, complementary medicine, neonatology, neonatal care, prematurity, allied health care

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, > 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.

Sites / Locations

  • Francesco Cerritelli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OMT

Control

Arm Description

patients under standard medical care plus OMT.

patients under standard medical care plus only osteopathic evaluation

Outcomes

Primary Outcome Measures

evaluate the effectiveness of OMT in reducing LOS

Secondary Outcome Measures

pre-post difference in weight gain

Full Information

First Posted
February 23, 2012
Last Updated
February 28, 2012
Sponsor
European Institute for Evidence Based Osteopathic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01544257
Brief Title
Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms
Official Title
Effect of OMT on Length of Stay in a Population of Preterm Infants: RCT Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OMT
Arm Type
Experimental
Arm Description
patients under standard medical care plus OMT.
Arm Title
Control
Arm Type
No Intervention
Arm Description
patients under standard medical care plus only osteopathic evaluation
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
Procedure
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
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 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

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, > 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Cerritelli, DO, MS
Organizational Affiliation
European Institute for Evidence Based Osteopathic Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Francesco Cerritelli
City
Pescara
ZIP/Postal Code
65124
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
23622070
Citation
Cerritelli F, Pizzolorusso G, Ciardelli F, La Mola E, Cozzolino V, Renzetti C, D'Incecco C, Fusilli P, Sabatino G, Barlafante G. Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial. BMC Pediatr. 2013 Apr 26;13:65. doi: 10.1186/1471-2431-13-65.
Results Reference
derived

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Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms

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