drugset / Trial / NCT01515696

Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants

NCT01515696

Phase 4 Completed 96 enrolled Nadja Haiden,MD
RandomizedParallel-groupTriple-blindTreatment

Summary

Gastrografin is a radiopaque contrast agent for the gastrointestinal tract (GIT) which can be applied orally or rectally. In neonatal intensive care, Gastrografin is used to detect otherwise radiologically invisible perforations or an insufficient GIT anastomosis after surgery. Furthermore it is used for the treatment of meconium ileus. Gastrografin has a strong osmotic effect and leads to water influx into the intestine lumen. Thereby the peristaltic movement is accelerated and the premature infant excretes stool during the hours following application. Therefore Gastrografin might be effective to mobilize meconium from small bowel and deep parts of the colon. The investigators hypothesized that enteral application of Gastrografin accelerates meconium evacuation in premature infants, and thereby enhances feeding tolerance in this population.

Timeline

Start
2007-10
Primary completion
2010-10
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gastrografin Diagnostic / imaging agent 3 unknown Other

Indications