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

• ClinicalTrials.gov Identifier: NCT01515696
• Recruitment Status: Completed
• First Posted: January 24, 2012
• Results First Posted: July 18, 2014
• Last Update Posted: July 18, 2014
• Sponsor: Nadja Haiden,MD
• Information provided by (Responsible Party): Nadja Haiden,MD, Medical University of Vienna

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Meconium Ileus; Very Low Birth Weight Infant	Drug: Gastrografin; Drug: Sterile water	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants- a Phase 4 Study
• Study Start Date: October 2007
• Actual Primary Completion Date: October 2010
• Actual Study Completion Date: February 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Gastrografin; infants receive 3ml/kg Gastrografin + 6ml/kg sterile water	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.; Other Names: Diatrizoate Meglumine, Diatrizoate Sodium; NDA-011245
Placebo Comparator: Sterile water; infants receive 9ml/kg sterile water	Drug: Sterile water; Patients will receive 9ml/kg sterile water as a single dose via a nasogastric tube during the first 24 hours of life.; Other Name: Sterile water (ANDA) #077393

Outcome Measures

Primary Outcome Measures :

1. Time to Complete Meconium Evacuation in Days [ Time Frame: 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 :

1. Feeding Tolerance- Full Enteral Feedings [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: up to 24 Hours (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Nadja Haiden,MD

Investigators

• Principal Investigator: Nadja Haiden, MD; Medical university of Vienna, Department of Pediatrics

More Information

• Responsible Party: Nadja Haiden,MD, Assoc.Prof.MD., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT01515696
• Other Study ID Numbers: 27112001; 2007-000851-33 ( EudraCT Number )
• First Posted: January 24, 2012
• Results First Posted: July 18, 2014
• Last Update Posted: July 18, 2014
• Last Verified: June 2014

Keywords provided by Nadja Haiden,MD, Medical University of Vienna:

VLBW infant; Meconium; Enteral nutrition; Meconium passage

Additional relevant MeSH terms:

Meconium Ileus; Body Weight; Birth Weight; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases