Effect of Osteopathic Manipulative Treatment on Pain in Preterms

Not Applicable

• Conditions: Prematurity
• Interventions: Other: Osteopathic manipulative treatment; Other: Sham therapy; Other: Usual care

• Registration Number: NCT02146677
• Lead Sponsor: European Institute for Evidence Based Osteopathic Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-26
• Study Start: 2014-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-12
• Last Update Posted: 2015-02-13
• Primary Completion: 2015-06
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Usual care	newborns will be osteopathically evaluated and softly touched
OMT	Osteopathic manipulative treatment	newborns will receive osteopathic evaluation and treatment according to international guidelines. Osteopathic treatment use will be indirect techniques.
Sham	Sham therapy	newborns will be osteopathically evaluated and softly touched
OMT	Usual care	newborns will receive osteopathic evaluation and treatment according to international guidelines. Osteopathic treatment use will be indirect techniques.
Usual care	Usual care	newborns will be undergone usual routine neonatology care

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of days of length of stay	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Trial Locations

Locations (1)

Pescara Civil Hospital; 🇮🇹 Pescara, PE, Italy