Effect of Osteopathic Manipulative Treatment on Pain in Preterms

Prematurity Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02146677
• Other study ID #: NEO-Pa 1
• Status: Recruiting
• Phase: N/A
• First received: May 20, 2014
• Last updated: February 12, 2015
• Start date: June 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2015
• Source: European Institute for Evidence Based Osteopathic Medicine
• Contact: Francesco Cerritelli, DO
• Phone: +393394332801
• Email: francesco.cerritelli[@]ebom.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 26 Weeks to 37 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

Other:
• Osteopathic manipulative treatment

• Sham therapy

• Usual care

Locations

Country	Name	City	State
Italy	Pescara Civil Hospital	Pescara	PE

Sponsors (1)

Lead Sponsor	Collaborator
European Institute for Evidence Based Osteopathic Medicine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neonatal intensive care unit cost		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Primary	changes from baseline in pain using Premature Infant Pain Profile (PIPP)		baseline and end of hospitalization, average length of hospitalization expected 4 weeks	No
Secondary	Number of days of length of stay		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No