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Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants

Primary Purpose

Meconium Ileus

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Osteopathic treatment
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meconium Ileus focused on measuring premature infant, visceral osteopathy, alternative medicine, meconium passage, enteral feedings, hospital stay

Eligibility Criteria

60 Minutes - 24 Hours (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • premature infants with a birthweight 1500 gram

Exclusion Criteria:

  • major congenital malformations
  • known gastrointestinal abnormalities

Sites / Locations

  • Nadja Haiden

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Osteopathic treatment group

Control group

Arm Description

visceral osteopathic treatment algorithm

no intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to full enteral feedings
Introduction of enteral feedings

Full Information

First Posted
May 10, 2014
Last Updated
May 14, 2014
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02140710
Brief Title
Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants
Official Title
The Impact of Visceral Osteopathic Treatment on the Meconium Evacuation in Very Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meconium Ileus
Keywords
premature infant, visceral osteopathy, alternative medicine, meconium passage, enteral feedings, hospital stay

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic treatment group
Arm Type
Active Comparator
Arm Description
visceral osteopathic treatment algorithm
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Procedure
Intervention Name(s)
Osteopathic treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
complete meconium evacuation
Description
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.
Time Frame
days up to 100 days of life
Secondary Outcome Measure Information:
Title
Time to full enteral feedings
Time Frame
days up to 100 days of life
Title
Introduction of enteral feedings
Time Frame
days up to 100 days of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Minutes
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: premature infants with a birthweight 1500 gram Exclusion Criteria: major congenital malformations known gastrointestinal abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadja Haiden, M.D.
Organizational Affiliation
MUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nadja Haiden
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
25875011
Citation
Haiden N, Pimpel B, Kreissl A, Jilma B, Berger A. Does visceral osteopathic treatment accelerate meconium passage in very low birth weight infants?- A prospective randomized controlled trial. PLoS One. 2015 Apr 15;10(4):e0123530. doi: 10.1371/journal.pone.0123530. eCollection 2015. Erratum In: PLoS One. 2017 Nov 2;12 (11):e0187784.
Results Reference
derived

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Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants

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