Meconium Ileus, Very Low Birth Weight Infant
Conditions
Keywords
VLBW infant, Meconium, Enteral nutrition, Meconium passage
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.
Interventions
Patients will receive 3ml Gastrografin + 6ml sterile water/kg as a single dose via a nasogastric tube during the first 24 hours of life.
Patients will receive 9ml/kg sterile water as a single dose via a nasogastric tube during the first 24 hours of life.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Meconium Evacuation in Days | days of life until until the complete meconium evacuation from birth up to 40 days of life | Time to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feeding Tolerance- Full Enteral Feedings | days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg | full enteral feeding is defined in days of life from birth until an an infant tolerates an enteral feeding volume of 140ml/kg |
Participant flow
Recruitment details
3 year study period 789 infants were eligible for enrollment in the study
Pre-assignment details
Six hundred ninety-three infants were excluded for the following reasons: informed consent was not obtained in time(n = 660), parental refusal (n = 21), and 12 infants died before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Gastrografin infants receive 3ml/kg Gastrografin + 6ml/kg sterile water | 47 |
| Sterile Water infants receive 9ml/kg sterile water | 49 |
| Total | 96 |
Baseline characteristics
| Characteristic | Gastrografin | Sterile Water | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 47 Participants | 49 Participants | 96 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| birthweight | 870 grams FULL_RANGE 0 | 900 grams FULL_RANGE 0 | 879 grams FULL_RANGE 0 |
| Region of Enrollment Austria | 47 participants | 49 participants | 96 participants |
| Sex: Female, Male Female | 27 Participants | 20 Participants | 47 Participants |
| Sex: Female, Male Male | 20 Participants | 29 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 47 | 6 / 49 |
| serious Total, serious adverse events | 43 / 47 | 42 / 49 |
Outcome results
Time to Complete Meconium Evacuation in Days
Time to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life
Time frame: days of life until until the complete meconium evacuation from birth up to 40 days of life
Population: per protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gastrografin | Time to Complete Meconium Evacuation in Days | 7 days of life |
| Sterile Water | Time to Complete Meconium Evacuation in Days | 8 days of life |
Feeding Tolerance- Full Enteral Feedings
full enteral feeding is defined in days of life from birth until an an infant tolerates an enteral feeding volume of 140ml/kg
Time frame: days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg
Population: per protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gastrografin | Feeding Tolerance- Full Enteral Feedings | 19 days |
| Sterile Water | Feeding Tolerance- Full Enteral Feedings | 26.5 days |
Necrotizing Enterocolitis
necrotizing enterocolitis stage 2a after Bell
Time frame: End of study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gastrografin | Necrotizing Enterocolitis | 8 participants |
| Sterile Water | Necrotizing Enterocolitis | 3 participants |