Clinical trial NCT02140710: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meconium Ileus
Keywords: premature infant
visceral osteopathy
alternative medicine
meconium passage
enteral feedings
hospital stay
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 41
Sex: ALL
Minimum age (years): 60
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* premature infants with a birthweight 1500 gram

Exclusion Criteria:

* major congenital malformations
* known gastrointestinal abnormalities

Primary outcomes:
measure: complete meconium evacuation
timeFrame: days up to 100 days of life
Secondary outcomes:
measure: Time to full enteral feedings
timeFrame: days up to 100 days of life
measure: Introduction of enteral feedings
timeFrame: days up to 100 days of life
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Nadja Haiden
Study officials:
affiliation: MUV
name: Nadja Haiden, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.