Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants

NCT02140710 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2014-05-16

No results posted yet for this study

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.

Conditions

  • Meconium Ileus

Interventions

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Nadja Haiden, M.D. · MUV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Minutes
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02140710 on ClinicalTrials.gov