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

Very Low Birth Weight Infant Clinical Trial

Official title:

Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants- a Phase 4 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515696
• Other study ID #: 27112001
• Secondary ID: 2007-000851-33
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2012
• Last updated: June 17, 2014
• Start date: October 2007
• Est. completion date: February 2011

Study information

• Verified date: June 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Meconium Ileus
• Very Low Birth Weight Infant

Intervention

Drug:
• Gastrografin
Patients will receive 3ml Gastrografin + 6ml sterile water/kg as a single dose via a nasogastric tube during the first 24 hours of life.
• Sterile water
Patients will receive 9ml/kg sterile water as a single dose via a nasogastric tube during the first 24 hours of life.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nadja Haiden,MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Complete Meconium Evacuation in Days	Time to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life	days of life until until the complete meconium evacuation from birth up to 40 days of life	No
Secondary	Feeding Tolerance- Full Enteral Feedings	full enteral feeding is defined in days of life from birth until an an infant tolerates an enteral feeding volume of 140ml/kg	days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg	No