Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms

Prematurity Clinical Trial

Official title:

Effect of OMT on Length of Stay in a Population of Preterm Infants: RCT Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544257
• Other study ID #: NEO-01
• Status: Completed
• Phase: Phase 4
• First received: February 23, 2012
• Last updated: February 28, 2012
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: February 2012
• 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 use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvement in several clinical outcomes. The aim of the present study is to show the effect of OMT on LOS in a sample of premature infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 29 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, > 37 weeks;

• osteopathic treatment performed > 14 days after birth;

• newborn transferred to/from other hospital;

• newborn from to HIV seropositive and/or drug addict mother;

• newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, 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.

Procedure:
• 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	Francesco Cerritelli	Pescara

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
Primary	evaluate the effectiveness of OMT in reducing LOS		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	pre-post difference in weight gain		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No