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Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical Trial

NCT01645137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 690

Last updated 2014-04-25

No results posted yet for this study

Summary

The use of complementary and alternative medicine in neonatal ward has been steadily rising during the last decade. This integrated medicine approach has been shown to be helpful to improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to premature infants to reduce the length of stay and to cope with clinical complications. Results from previous studies documented the positive association between OMT and shorter period of hospitalisation as well as improvement of clinical conditions. The aim of this nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in premature infants across 3 neonatal intensive care units (NICU).

Conditions

  • Prematurity

Interventions

OTHER

osteopathic manipulative treatment

Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.

OTHER

Usual care

Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

Sponsors & Collaborators

  • Italian Academy of Traditional Osteopathy - AIOT

    collaborator OTHER

  • European Institute for Evidence Based Osteopathic Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
29 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-09-30
Completion
2013-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01645137 on ClinicalTrials.gov