Effect of Osteopathic Manipulative Treatment on Pain in Preterms

European Institute for Evidence Based Osteopathic Medicine120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Prematurity

Interventions

Eligibility

Sex: ALLMin age: 26 WeeksMax age: 37 Weeks

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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 Outcomes

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