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

NCT ID: NCT01515696

Last Updated: 2014-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-02-28

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.

Conditions

Meconium Ileus; Very Low Birth Weight Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Gastrografin

infants receive 3ml/kg Gastrografin + 6ml/kg sterile water

Group Type: ACTIVE_COMPARATOR

Gastrografin

Intervention Type: DRUG

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

infants receive 9ml/kg sterile water

Group Type: PLACEBO_COMPARATOR

Sterile water

Intervention Type: DRUG

Patients will receive 9ml/kg sterile water as a single dose via a nasogastric tube during the first 24 hours of life.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Diatrizoate Meglumine, Diatrizoate Sodium; NDA-011245; Sterile water (ANDA) #077393

Eligibility 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

• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nadja Haiden,MD

OTHER

Sponsor Role: lead

Responsible Party

Nadja Haiden,MD

Assoc.Prof.MD.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nadja Haiden, MD

Role: PRINCIPAL_INVESTIGATOR

Medical university of Vienna, Department of Pediatrics

Other Identifiers

2007-000851-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

27112001

Identifier Type: -

Identifier Source: org_study_id