Phase 4
N=96
Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants
Meconium Ileus · Very Low Birth Weight Infant
Bottom Line
View on ClinicalTrials.gov: NCT01515696 ↗Enrolled (actual)
96
Serious AEs
88.5%
Results posted
Jul 2014
Primary outcome: Primary: Time to Complete Meconium Evacuation in Days — 7; 8 days of life — p=0.61
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gastrografin (Drug); Sterile water (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Nadja Haiden,MD
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Complete Meconium Evacuation in Days |
7; 8 | 0.61 |
| SECONDARY Feeding Tolerance- Full Enteral Feedings |
19; 26.5 | 0.05 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01515696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.