Early Exposure to OMT Prevents Long LOS
1 other identifier
interventional
113
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 4, 2013
CompletedFirst Posted
Study publicly available on registry
February 6, 2013
CompletedFebruary 6, 2013
February 1, 2013
1.8 years
February 4, 2013
February 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of days of LOS
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary Outcomes (1)
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
Study Arms (2)
control
OTHERpatients under standard medical care
OMT
EXPERIMENTALpatients under usual medical care plus osteopathic treatment
Interventions
Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
Eligibility Criteria
You may qualify if:
- preterm infants born at age between 29 and 37 weeks
- osteopathic treatment performed \< 14 days after birth
- preterms born in the same hospital
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Macerata Hospital
Macerata, Macerata, 62100, Italy
Related 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.
PMID: 21711535BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2013
First Posted
February 6, 2013
Study Start
October 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
February 6, 2013
Record last verified: 2013-02