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Effect of Osteopathic Manipulative Treatment on Pain in Preterms

Primary Purpose

Prematurity

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Osteopathic manipulative treatment
Sham therapy
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, newborns, pain, cost

Eligibility Criteria

26 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • preterm infants
  • written informed consent by parents or legal guardians
  • preterms born in the same hospital

Exclusion Criteria:

  • Gestational age > 37 weeks
  • 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

  • Pescara Civil HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Sham

Usual care

OMT

Arm Description

newborns will be osteopathically evaluated and softly touched

newborns will be undergone usual routine neonatology care

newborns will receive osteopathic evaluation and treatment according to international guidelines. Osteopathic treatment use will be indirect techniques.

Outcomes

Primary Outcome Measures

changes from baseline in pain using Premature Infant Pain Profile (PIPP)

Secondary Outcome Measures

Number of days of length of stay

Full Information

First Posted
May 20, 2014
Last Updated
February 12, 2015
Sponsor
European Institute for Evidence Based Osteopathic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02146677
Brief Title
Effect of Osteopathic Manipulative Treatment on Pain in Preterms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

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
Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns. Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs (Cerritelli, 2013) as well as the likelihood of gastrointestinal episodes (Pizzolorusso 2011). Moreover it was reported the absence of adverse events and side effects considering the approach safe (Cerritelli 2013, 2014). OMT was extensively used to treat, prevent and manage pain symptoms. Numerous research was published addressing acute and chronic pain in different medical conditions. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of OMT in reducing pain in a sample of preterm infants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
prematurity, newborns, pain, cost

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham
Arm Type
Other
Arm Description
newborns will be osteopathically evaluated and softly touched
Arm Title
Usual care
Arm Type
Other
Arm Description
newborns will be undergone usual routine neonatology care
Arm Title
OMT
Arm Type
Other
Arm Description
newborns will receive osteopathic evaluation and treatment according to international guidelines. Osteopathic treatment use will be indirect techniques.
Intervention Type
Other
Intervention Name(s)
Osteopathic manipulative treatment
Intervention Type
Other
Intervention Name(s)
Sham therapy
Intervention Type
Other
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
changes from baseline in pain using Premature Infant Pain Profile (PIPP)
Time Frame
baseline and end of hospitalization, average length of hospitalization expected 4 weeks
Secondary Outcome Measure Information:
Title
Number of days of length of stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other Pre-specified Outcome Measures:
Title
Neonatal intensive care unit cost
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
26 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: preterm infants written informed consent by parents or legal guardians preterms born in the same hospital Exclusion Criteria: Gestational age > 37 weeks 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Cerritelli, DO
Phone
+393394332801
Email
francesco.cerritelli@ebom.it
Facility Information:
Facility Name
Pescara Civil Hospital
City
Pescara
State/Province
PE
ZIP/Postal Code
65100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Cerritelli
Phone
+393394332801
Email
francesco.cerritelli@ebom.it

12. IPD Sharing Statement

Citations:
PubMed Identifier
25872943
Citation
Cerritelli F, Cicchitti L, Martelli M, Barlafante G, Renzetti C, Pizzolorusso G, Lupacchini M, D'Orazio M, Marinelli B, Cozzolino V, Fusilli P, D'Incecco C. Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial. Trials. 2015 Mar 8;16:84. doi: 10.1186/s13063-015-0615-3.
Results Reference
derived

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Effect of Osteopathic Manipulative Treatment on Pain in Preterms

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