Effect of Osteopathic Manipulative Treatment on Pain in Preterms

Study Overview
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Brief Summary
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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.

Conditions
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Prematurity

Intervention / Treatment
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* Other: Osteopathic manipulative treatment
* Other: Sham therapy
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 26 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sham<br>newborns will be osteopathically evaluated and softly touched | Other: Sham therapy<br> <br> Other: Usual care<br> <br> |
| Other: Usual care<br>newborns will be undergone usual routine neonatology care | Other: Usual care<br> <br> |
| Other: OMT<br>newborns will receive osteopathic evaluation and treatment according to international guidelines. Osteopathic treatment use will be indirect techniques. | Other: Osteopathic manipulative treatment<br> <br> Other: Usual care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes from baseline in pain using Premature Infant Pain Profile (PIPP) |  | baseline and end of hospitalization, average length of hospitalization expected 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days of length of stay |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prematurity, newborns, pain, cost