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Effect of Osteopathic Manipulative Treatment on Pain in Preterms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02146677
Recruitment Status : Unknown
Verified February 2015 by European Institute for Evidence Based Osteopathic Medicine.
Recruitment status was:  Recruiting
First Posted : May 26, 2014
Last Update Posted : February 13, 2015
Sponsor:
Information provided by (Responsible Party):
European Institute for Evidence Based Osteopathic Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prematurity Other: Osteopathic manipulative treatment Other: Sham therapy Other: Usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : September 2015
Arms and Interventions
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Arm Intervention/treatment
Sham
newborns will be osteopathically evaluated and softly touched
 Other: Sham therapy
Other: Usual care
Usual care
newborns will be undergone usual routine neonatology care
 Other: Usual care
OMT
newborns will receive osteopathic evaluation and treatment according to international guidelines. Osteopathic treatment use will be indirect techniques.
 Other: Osteopathic manipulative treatment
Other: Usual care


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 Outcome Measures:
  1. Neonatal intensive care unit cost [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   26 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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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): NCT02146677


Contacts
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Contact: Francesco Cerritelli, DO +393394332801 francesco.cerritelli@ebom.it

Locations
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Italy
Pescara Civil Hospital Recruiting
Pescara, PE, Italy, 65100
Contact: Francesco Cerritelli    +393394332801    francesco.cerritelli@ebom.it   
Sponsors and Collaborators
European Institute for Evidence Based Osteopathic Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: European Institute for Evidence Based Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT02146677    
Other Study ID Numbers: NEO-Pa 1
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015
Keywords provided by European Institute for Evidence Based Osteopathic Medicine:
prematurity
newborns
pain
cost
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications