Early Exposure to OMT Prevents Long LOS

Prematurity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784835
• Other study ID #: NEO-02
• Status: Completed
• Phase: N/A
• First received: February 4, 2013
• Last updated: February 4, 2013
• Start date: October 2010
• Est. completion date: July 2012

Study information

• Verified date: February 2013
• Source: European Institute for Evidence Based Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The application of osteopathic manipulative treatment (OMT) in preterm infants has been demonstrated to be effective in reducing length of stay (LOS). The scope of the present study is to investigate the association between earlier exposure to OMT and reduction of LOS in premature infants

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 32 Weeks to 37 Weeks

Eligibility

Inclusion Criteria:

• preterm infants born at age between 29 and 37 weeks

• osteopathic treatment performed < 14 days after birth

• preterms born in the same hospital

Exclusion Criteria:

• Gestational age < 29 weeks

• Gestational age > 37 weeks

• First OMT performed after 14 days from birth

• 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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

Other:
• osteopathic manipulative treatment
Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
• Usual care
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

Locations

Country	Name	City	State
Italy	Macerata Hospital	Macerata

Sponsors (1)

Lead Sponsor	Collaborator
European Institute for Evidence Based Osteopathic Medicine

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Pizzolorusso G, Turi P, Barlafante G, Cerritelli F, Renzetti C, Cozzolino V, D'Orazio M, Fusilli P, Carinci F, D'Incecco C. Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study. Chiropr Man Therap. 2011 Jun 28;19(1):15. doi: 10.1186/2045-709X-19-15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days of LOS		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	effectiveness of OMT considering different lag time between birth and the first OMT		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No