At a glance
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Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants- a Phase 4 Study
In Brief
A Phase 4 clinical trial evaluating Gastrografin and Sterile water for Meconium Ileus and Very Low Birth Weight Infant. Completed, enrolled 96 participants.
Detailed 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.
Study Details
Timeline
Interventions
Patients will receive 3ml Gastrografin + 6ml sterile water/kg as a single dose via a nasogastric tube during the first 24 hours of life.
Patients will receive 9ml/kg sterile water as a single dose via a nasogastric tube during the first 24 hours of life.