Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants

NCT02140710 | Completed Phase 4

• 1 other identifier: OST2010
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Meconium Ileus

Keywords

premature infant; visceral osteopathy; alternative medicine; meconium passage; enteral feedings; hospital stay

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to full enteral feedings

  days up to 100 days of life

• Introduction of enteral feedings

  days up to 100 days of life

Study Arms (2)

Osteopathic treatment group

ACTIVE COMPARATOR

visceral osteopathic treatment algorithm

Procedure: Osteopathic treatment

Control group

NO INTERVENTION

no intervention

Interventions

Osteopathic treatment PROCEDURE

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

Osteopathic treatment group

Eligibility Criteria

• Age: 60 Minutes - 24 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• premature infants with a birthweight 1500 gram

You may not qualify if:

• major congenital malformations
• known gastrointestinal abnormalities

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Nadja Haiden

Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 25875011 DERIVED

MeSH Terms

Conditions

Meconium Ileus; Premature Birth

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Nadja Haiden, M.D.

  MUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 10, 2014
• First Posted: May 16, 2014
• Study Start: December 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 16, 2014

Record last verified: 2014-05

Locations

AU (1)