Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants

Phase 4

Completed

• Conditions: Meconium Ileus
• Interventions: Procedure: Osteopathic treatment

• Registration Number: NCT02140710
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2014-05
• Study First Submitted: 2014-05-10
• Study First Submitted QC: 2014-05-14
• Last Update Submitted: 2014-05-14
• Study First Posted: 2014-05-16
• Last Update Posted: 2014-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• premature infants with a birthweight 1500 gram

Read More

Exclusion Criteria

• major congenital malformations
• known gastrointestinal abnormalities

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteopathic treatment group	Osteopathic treatment	visceral osteopathic treatment algorithm

Primary Outcome Measures

Name	Time	Method
complete meconium evacuation	days up to 100 days of life	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.

Secondary Outcome Measures

Name	Time	Method
Time to full enteral feedings	days up to 100 days of life
Introduction of enteral feedings	days up to 100 days of life

Trial Locations

Locations (1)

Nadja Haiden; 🇦🇹 Vienna, Austria