Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants
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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 |
- 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.
- 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
| Enrollment: | 78 |
| 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:
|
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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 |
| Last Updated: | March 1, 2013 |
| 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 May 21, 2013