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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nadja Haiden,MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01515696
First received: January 10, 2012
Last updated: March 1, 2013
Last verified: March 2013

January 10, 2012
March 1, 2013
October 2007
October 2010   (final data collection date for primary outcome measure)
Time to complete meconium evacuation in days [ Time Frame: 8 Days ] [ Designated as safety issue: No ]

Time to complete meconium evacuation in days, which is expected by an average of 8 days after birth.

Participants will be followed for the duration of hospital stay. Usually they are discharged in their 36 week of gestation- 4 weeks before expected date of term.

Same as current
Complete list of historical versions of study NCT01515696 on ClinicalTrials.gov Archive Site
Feeding tolerance [ Time Frame: Up to 30 days to full enteral feeding ] [ Designated as safety issue: No ]
Up to 30 days of life to full enteral feeding- full enteral feeding is defined if an infant tolerates an enteral feeding volume of 140ml/kg
Same as current
Not Provided
Not Provided
 
Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants
Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants- a Phase 4 Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Meconium Ileus
  • Very Low Birth Weight Infant
  • 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
  • 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
  • Active Comparator: Gastrografin
    infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
    Intervention: Drug: Gastrografin
  • Placebo Comparator: Sterile water
    infants receive 9ml/kg sterile water
    Intervention: Drug: Sterile water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
February 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01515696
27112001, 2007-000851-33
Yes
Nadja Haiden,MD, Medical University of Vienna
Nadja Haiden,MD
Not Provided
Principal Investigator: Nadja Haiden, MD Medical university of Vienna, Department of Pediatrics
Medical University of Vienna
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP