Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants

Meconium Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140710
• Other study ID #: OST2010
• Status: Completed
• Phase: Phase 4
• First received: May 10, 2014
• Last updated: May 14, 2014
• Start date: December 2010
• Est. completion date: February 2012

Study information

• Verified date: May 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Medical University of Vienna
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

Inclusion Criteria:

• premature infants with a birthweight 1500 gram

Exclusion Criteria:

• major congenital malformations

• known gastrointestinal abnormalities

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meconium Ileus

Intervention

Procedure:
• Osteopathic treatment
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

Locations

Country	Name	City	State
Austria	Nadja Haiden	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to full enteral feedings		days up to 100 days of life	Yes
Secondary	Introduction of enteral feedings		days up to 100 days of life	Yes