Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants

NCT ID: NCT02140710

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-02-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Osteopathic treatment group

visceral osteopathic treatment algorithm

Group Type: ACTIVE_COMPARATOR

Osteopathic treatment

Intervention Type: 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

Control group

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• premature infants with a birthweight 1500 gram

Exclusion Criteria

• major congenital malformations
• known gastrointestinal abnormalities

• Minimum Eligible Age: 60 Minutes
• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Nadja Haiden,MD

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadja Haiden, M.D.

Role: PRINCIPAL_INVESTIGATOR

MUV

Locations

Nadja Haiden

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 25875011 (View on PubMed)

Other Identifiers

OST2010

Identifier Type: -

Identifier Source: org_study_id