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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01515696
Enrollment
96
Registered
2012-01-24
Start date
2007-10-31
Completion date
2011-02-28
Last updated
2014-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meconium Ileus, Very Low Birth Weight Infant

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.

DRUGSterile water

Patients will receive 9ml/kg sterile water as a single dose via a nasogastric tube during the first 24 hours of life.

Sponsors

Nadja Haiden,MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 24 Hours
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

Design outcomes

Primary

MeasureTime frameDescription
Time to Complete Meconium Evacuation in Daysdays of life until until the complete meconium evacuation from birth up to 40 days of lifeTime to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life

Secondary

MeasureTime frameDescription
Feeding Tolerance- Full Enteral Feedingsdays of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kgfull 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

ArmCount
Gastrografin
infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
47
Sterile Water
infants receive 9ml/kg sterile water
49
Total96

Baseline characteristics

CharacteristicGastrografinSterile WaterTotal
Age, Categorical
<=18 years
47 Participants49 Participants96 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
birthweight870 grams
FULL_RANGE 0
900 grams
FULL_RANGE 0
879 grams
FULL_RANGE 0
Region of Enrollment
Austria
47 participants49 participants96 participants
Sex: Female, Male
Female
27 Participants20 Participants47 Participants
Sex: Female, Male
Male
20 Participants29 Participants49 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
5 / 476 / 49
serious
Total, serious adverse events
43 / 4742 / 49

Outcome results

Primary

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

ArmMeasureValue (MEDIAN)
GastrografinTime to Complete Meconium Evacuation in Days7 days of life
Sterile WaterTime to Complete Meconium Evacuation in Days8 days of life
p-value: 0.61Wilcoxon (Mann-Whitney)
Secondary

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

ArmMeasureValue (MEDIAN)
GastrografinFeeding Tolerance- Full Enteral Feedings19 days
Sterile WaterFeeding Tolerance- Full Enteral Feedings26.5 days
p-value: 0.05Wilcoxon (Mann-Whitney)
Post Hoc

Necrotizing Enterocolitis

necrotizing enterocolitis stage 2a after Bell

Time frame: End of study

ArmMeasureValue (NUMBER)
GastrografinNecrotizing Enterocolitis8 participants
Sterile WaterNecrotizing Enterocolitis3 participants
p-value: >0.05Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026