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Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Institute for Evidence Based Osteopathic Medicine
ClinicalTrials.gov Identifier:
NCT01544257
First received: February 23, 2012
Last updated: February 28, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prematurity
 Other: osteopathic manipulative treatment
Procedure: Usual care
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

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

Primary Outcome Measures:
  • evaluate the effectiveness of OMT in reducing 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 ]

Enrollment: 100
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OMT
patients under standard medical care plus OMT.
 Other: osteopathic manipulative treatment
Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
No Intervention: Control
patients under standard medical care plus only osteopathic evaluation
 Procedure: 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, > 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544257

Locations
Italy
Francesco Cerritelli
Pescara, Italy, 65124
Sponsors and Collaborators
European Institute for Evidence Based Osteopathic Medicine
Investigators
Study Chair: Francesco Cerritelli, DO, MS European Institute for Evidence Based Osteopathic Medicine
  More Information

No publications provided

Responsible Party: European Institute for Evidence Based Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT01544257     History of Changes
Other Study ID Numbers: NEO-01
Study First Received: February 23, 2012
Last Updated: February 28, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by European Institute for Evidence Based Osteopathic Medicine:
Osteopathic manipulative treatment
alternative medicine
complementary medicine
neonatology
 neonatal care
prematurity
allied health care

ClinicalTrials.gov processed this record on May 19, 2013