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

This study is currently recruiting participants.
Verified July 2013 by European Institute for Evidence Based Osteopathic Medicine
Sponsor:
Collaborator:
Accademia Italiana Osteopatia Tradizionale
Information provided by (Responsible Party):
European Institute for Evidence Based Osteopathic Medicine
ClinicalTrials.gov Identifier:
NCT01645137
First received: July 15, 2012
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention
Prematurity
Other: osteopathic manipulative treatment
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness Of Osteopathic Manipulative Treatment In Neonatal Intensive Care Units: A Multicenter Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by European Institute for Evidence Based Osteopathic Medicine:

Primary Outcome Measures:
  • Number of days of LOS [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pre-post difference in weight gain [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • number of episodes of vomit [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • days to full enteral feeding [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • NICU costs [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • number of episodes of regurgitation [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • number of episodes of stooling [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 690
Study Start Date: July 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OMT
patients under usual medical care plus osteopathic treatment
Other: osteopathic manipulative treatment
Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
control
patients under usual medical care
Other: Usual care
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

  Eligibility

Ages Eligible for Study:   29 Weeks to 37 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01645137

Contacts
Contact: Francesco Cerritelli, DO, MS +393394332801 francesco.cerritelli@ebom.it

Locations
Italy
Monza Hospital Recruiting
Monza, Lombardia, Italy, 20052
Macerata Hospital Recruiting
Macerata, Marche, Italy, 62100
Sub-Investigator: Alessandro Accorsi, DO, BSN         
Pescara hospital Recruiting
Pescara, Italy, 65121
Principal Investigator: Francesco Cerritelli, DO, MS         
Sponsors and Collaborators
European Institute for Evidence Based Osteopathic Medicine
Accademia Italiana Osteopatia Tradizionale
  More Information

Additional Information:
No publications provided

Responsible Party: European Institute for Evidence Based Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT01645137     History of Changes
Other Study ID Numbers: Multi-NE-O
Study First Received: July 15, 2012
Last Updated: July 19, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by European Institute for Evidence Based Osteopathic Medicine:
prematurity
OMT
complementary and alternative medicine
neonates
length of stay

ClinicalTrials.gov processed this record on April 16, 2014