Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of Visceral Osteopathic Treatment on the Meconium Evacuation in Very Low Birth Weight Infants

Conditions
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Meconium Ileus

Intervention / Treatment
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* Procedure: Osteopathic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: premature infants with a birthweight 1500 gram Exclusion Criteria: major congenital malformations known gastrointestinal abnormalities

Ages Eligible for Study
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Minimum Age: 60 Minutes
Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Osteopathic treatment group<br>visceral osteopathic treatment algorithm | Procedure: Osteopathic treatment<br>* 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<br>|
| No Intervention: Control group<br>no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete meconium evacuation | 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. | days up to 100 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to full enteral feedings |  | days up to 100 days of life | 
| Introduction of enteral feedings |  | days up to 100 days of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature infant, visceral osteopathy, alternative medicine, meconium passage, enteral feedings, hospital stay