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

Phase 4

Completed

• Conditions: Meconium Ileus; Very Low Birth Weight Infant
• Interventions: Drug: Sterile water; Drug: Gastrografin

• Registration Number: NCT01515696
• Lead Sponsor: Nadja Haiden,MD

Brief 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.

Detailed Description

In premature infants the establishment of proper gastrointestinal function is challenging and often associated with delayed meconium passage. Meconium evacuation depends on gestational age and birthweight: the more immature an infant is, the later meconium passage starts and the longer meconium passage lasts. The mean duration of meconium evacuation in premature infants with a gestational age below 30 weeks is 8 days, while mature infants excrete their meconium in 2 days. The obstruction of deep intestinal segments by tenacious, sticky meconium frequently leads to gastric residuals, a distended abdomen and delayed food passage. The time lag to full enteral feedings is extended, the probability to acquire infections due to intravenous access for parenteral nutrition increases and the hospital stay of the infant is prolonged. However, the relation between meconium passage and feeding tolerance remains controversial. While one study showed that there is little concordance between first meconium passage and feeding tolerance, an other one showed that rapid and complete excretion of meconium is crucial for oral feeding tolerance and has a positive effect on it. Recently, the investigators performed a prospective randomized trial to determine, whether repeated prophylactic applications of small volume glycerin enemas accelerate passage of meconium in very low birth weight (VLBW) infants. Disappointingly, application of enemas did not accelerate meconium evacuation. A possible reason for the ineffectiveness of glycerin enemas is that the volume used was too small to mobilize tenacious meconium sufficiently from the colon and small bowel.

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 more 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. The objective of the present study is to determine whether the enteral application of the osmotic contrast agent Gastrografin® accelerates complete meconium excretion and improves feeding tolerance in very low birth weight infants.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2010-10
• Study Completion: 2011-02
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-24
• Results First Submitted: 2013-10-29
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-17
• Last Update Submitted: 2014-06-17
• Results First Posted: 2014-07-18
• Last Update Posted: 2014-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• premature infants with a birthweight < 1500g and a gestational age < 32 weeks

Exclusion Criteria

• major congenital disorders
• chromosomal aberrations
• systemic metabolic disease and
• pre-existing gastrointestinal abnormalities (i.e. Morbus Hirschsprung)
• pre-existing conditions of severe hypotension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sterile water	Sterile water	infants receive 9ml/kg sterile water
Gastrografin	Gastrografin	infants receive 3ml/kg Gastrografin + 6ml/kg sterile water

Primary Outcome Measures

Name	Time	Method
Time to Complete Meconium Evacuation in Days	days of life until until the complete meconium evacuation from birth up to 40 days of life	Time to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life

Secondary Outcome Measures

Name	Time	Method
Feeding Tolerance- Full Enteral Feedings	days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg	full enteral feeding is defined in days of life from birth until an an infant tolerates an enteral feeding volume of 140ml/kg