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: June 17, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Meconium Ileus
Very Low Birth Weight Infant
Drug: Gastrografin
Drug: Sterile water
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Feeding Tolerance- Full Enteral Feedings [ Time Frame: days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg ] [ Designated as safety issue: No ]
    full enteral feeding is defined in days of life from birth until an an infant tolerates an enteral feeding volume of 140ml/kg


Enrollment: 96
Study Start Date: October 2007
Study Completion Date: February 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01515696

Sponsors and Collaborators
Nadja Haiden,MD
Investigators
Principal Investigator: Nadja Haiden, MD Medical university of Vienna, Department of Pediatrics
  More Information

No publications provided

Responsible Party: Nadja Haiden,MD, Assoc.Prof.MD., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01515696     History of Changes
Other Study ID Numbers: 27112001, 2007-000851-33
Study First Received: January 10, 2012
Results First Received: October 29, 2013
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
VLBW infant
Meconium
Enteral nutrition
Meconium passage

Additional relevant MeSH terms:
Birth Weight
Intestinal Obstruction
Fetal Diseases
Cystic Fibrosis
Ileus
Body Weight
Signs and Symptoms
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pregnancy Complications
Pancreatic Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on July 26, 2014