- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02140710
Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants
May 14, 2014 updated by: Nadja Haiden,MD, Medical University of Vienna
The Impact of Visceral Osteopathic Treatment on the Meconium Evacuation in Very Low Birth Weight Infants
Timing of the first and last meconium stool is critical for oral feeding tolerance and proper gastrointestinal function.
The time until premature infants pass their first meconium ranges from 1 hour to 27 days (median: 43 hours).
Obstruction of the gastrointestinal tract by tenacious, sticky meconium frequently leads to gastric residuals, a distended abdomen and delayed food passage Recent data support the concept that complete rapid evacuation of meconium plays a key role in feeding tolerance .
If duration to full enteral feedings is extended, the probability to acquire infections due to intravenous access for parenteral nutrition increases and hospital stay of the infant prolongates.
Previously two prospective trials focusing on the problem of delayed meconium evacuation in preterm with different therapeutic pharmacological approaches were published by our group.
None of the applied therapies appeared to be effective or had a beneficial effect- quite the contrary one agent (Gastrografin) was supposed to have severe negative side effects.
Therefore we were looking for an alternative, non-invasive, holistic solution for the problem of delayed meconium excretion.
Osteopathic treatment with the emphasis on the relationship of the structural and functional integrity of the body and with its variety of therapeutic manual techniques seemed to be remedy.
Treating the abdomen of premature infants with visceral osteopathic techniques might be more effective to mobilize meconium from small bowel and deep parts of the colon.
Therefore we hypothesized that repeated visceral osteopathic treatment accelerates meconium evacuation in premature infants, and thereby enhances feeding tolerance in this population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, 1090
- Nadja Haiden
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 hour to 1 day (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- premature infants with a birthweight 1500 gram
Exclusion Criteria:
- major congenital malformations
- known gastrointestinal abnormalities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
no intervention
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Active Comparator: Osteopathic treatment group
visceral osteopathic treatment algorithm
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visceral osteopathic treatment algorithm: Global listening and local listening on the abdomen Release lower ribs and thoracic diaphragm Pylorusrelaxation Release of the Duodenum and the C-Loop Small intestine diagnosis- Lifting the gut and bringing it to a stillpoint Root of mesentery diagnosis (and manipulation) Mobilisation of the ileocoecalic valve Mobilisation of colon ascendens, transversum, descendens Root of sigmoid diagnosis and manipulation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complete meconium evacuation
Time Frame: days up to 100 days of life
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Primary outcome parameter was specified as complete meconium excretion.
The time to complete meconium evacuation was defined as day of life on which the last meconium was passed.
The nursing staff assessed the quality of stools as "meconium" (black, thick, sticky) or "non meconium" by appearance and documented data into the electronic patient documentation system.
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days up to 100 days of life
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to full enteral feedings
Time Frame: days up to 100 days of life
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days up to 100 days of life
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Introduction of enteral feedings
Time Frame: days up to 100 days of life
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days up to 100 days of life
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nadja Haiden, M.D., MUV
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
May 10, 2014
First Submitted That Met QC Criteria
May 14, 2014
First Posted (Estimate)
May 16, 2014
Study Record Updates
Last Update Posted (Estimate)
May 16, 2014
Last Update Submitted That Met QC Criteria
May 14, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OST2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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