Meconium IleusPhase 4NCT01515696
Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants
A Phase 4 study testing Gastrografin and Sterile water in people with Meconium Ileus and Very Low Birth Weight Infant, run by Nadja Haiden,MD.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Meconium Ileus, Very Low Birth Weight Infant
- What is being tested?
- Gastrografin and Sterile water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Feb 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- premature infants with a birthweight < 1500g and a gestational age < 32 weeks
Who cannot join
- major congenital disorders
- chromosomal aberrations
- systemic metabolic disease and
- pre-existing gastrointestinal abnormalities (i.e. Morbus Hirschsprung)
- pre-existing conditions of severe hypotension
About this study
Official title: Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants- a Phase 4 Study
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.
Read the 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.
- Conditions
- Meconium Ileus, Very Low Birth Weight Infant
- Being tested
- Gastrografin, Sterile water
- Keywords
- VLBW infant, Meconium, Enteral nutrition, Meconium passage
- Medical subject headings
- Meconium Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrografinDrug
Also called Diatrizoate Meglumine, Diatrizoate Sodium, NDA-011245
Patients will receive 3ml Gastrografin + 6ml sterile water/kg as a single dose via a nasogastric tube during the first 24 hours of life.
Sterile waterDrug
Also called Sterile water (ANDA) #077393
Patients will receive 9ml/kg sterile water as a single dose via a nasogastric tube during the first 24 hours of life.
| Study group | Role | What they receive |
|---|---|---|
| Gastrografin | Active comparator | infants receive 3ml/kg Gastrografin + 6ml/kg sterile water Receives: Drug: Gastrografin |
| Sterile water | Placebo comparator | infants receive 9ml/kg sterile water Receives: Drug: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: days of life until until the complete meconium evacuation from birth up to 40 days of life
Secondary outcomes (1)
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
Measured: days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startOct 2007
- Primary completionOct 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meconium IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nadja Haiden,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nadja Haiden,MD, Medical University of Vienna
- Investigators
- Nadja Haiden, MD, Principal investigator, Medical university of Vienna, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515696
- Sponsor's protocol ID
- 27112001
- Other IDs
- 2007-000851-33
- Status last verified
- Jun 2014
- First submitted
- 10 Jan 2012
- Last updated
- 18 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants- a Phase 4 Study
- ClinicalTrials.gov ID
- NCT01515696
- Acronym / sponsor ID
- 27112001
- Conditions
- Meconium Ileus, Very Low Birth Weight Infant
- Keywords
- VLBW infant, Meconium, Enteral nutrition, Meconium passage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Nadja Haiden,MDUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Posted 18 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastrografin | Active comparator | Drug: Gastrografininfants receive 3ml/kg Gastrografin + 6ml/kg sterile water |
| Sterile water | Placebo comparator | Drug: Sterile waterinfants receive 9ml/kg sterile water |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- premature infants with a birthweight < 1500g and a gestational age < 32 weeks
Key exclusion criteria (5 listed)
- major congenital disorders
- chromosomal aberrations
- systemic metabolic disease and
- pre-existing gastrointestinal abnormalities (i.e. Morbus Hirschsprung)
- pre-existing conditions of severe hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastrografinAlso: Diatrizoate Meglumine, Diatrizoate Sodium, NDA-011245Patients will receive 3ml Gastrografin + 6ml sterile water/kg as a single dose via a nasogastric tube during the first 24 hours of life. | Drug | Gastrografin |
| Sterile waterAlso: Sterile water (ANDA) #077393Patients will receive 9ml/kg sterile water as a single dose via a nasogastric tube during the first 24 hours of life. | Drug | Sterile water |
Primary outcome
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
Time to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life
1 secondary outcome
Feeding Tolerance- Full Enteral Feedings
Time frame: days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Meconium Ileus
Recruiting
Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.
Meconium Obstruction of Prematurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadja Haiden, MD principal investigator
Medical university of Vienna, Department of Pediatrics
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gastrografin and Sterile water in people with Meconium Ileus and Very Low Birth Weight Infant, run by Nadja Haiden,MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.