Impact of Visceral Osteopathic Treatment on Meconium Evacuation in Preterm Infants

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Meconium Ileus

Treatments: Procedure: Osteopathic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02140710

OST2010

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 60 minutes to 24 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• premature infants with a birthweight 1500 gram

Exclusion criteria

• major congenital malformations
• known gastrointestinal abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

41 participants in 2 patient groups

Osteopathic treatment group

Active Comparator group

Description:

visceral osteopathic treatment algorithm

Treatment:

Procedure: Osteopathic treatment

Control group

No Intervention group

Description:

no intervention