NCT01515696

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2007

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

July 18, 2014

Completed
Last Updated

July 18, 2014

Status Verified

June 1, 2014

Enrollment Period

3 years

First QC Date

January 10, 2012

Results QC Date

October 29, 2013

Last Update Submit

June 17, 2014

Conditions

Meconium IleusVery Low Birth Weight Infant

Keywords

VLBW infantMeconiumEnteral nutritionMeconium passage

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg

Study Arms (2)

Gastrografin

ACTIVE COMPARATOR

infants receive 3ml/kg Gastrografin + 6ml/kg sterile water

Drug: Gastrografin

Sterile water

PLACEBO COMPARATOR

infants receive 9ml/kg sterile water

Drug: Sterile water

Interventions

GastrografinDRUG

Patients will receive 3ml Gastrografin + 6ml sterile water/kg as a single dose via a nasogastric tube during the first 24 hours of life.

Also known as: Diatrizoate Meglumine, Diatrizoate Sodium, NDA-011245
Gastrografin
Sterile waterDRUG

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

Also known as: Sterile water (ANDA) #077393
Sterile water

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • premature infants with a birthweight \< 1500g and a gestational age \< 32 weeks

You may not qualify if:

  • major congenital disorders
  • chromosomal aberrations
  • systemic metabolic disease and
  • pre-existing gastrointestinal abnormalities (i.e. Morbus Hirschsprung)
  • pre-existing conditions of severe hypotension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meconium Ileus

Interventions

Diatrizoate MeglumineDiatrizoate

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

MeglumineSorbitolSugar AlcoholsAlcoholsOrganic ChemicalsTriiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsHexosaminesAmino SugarsCarbohydrates

Results Point of Contact

Title
Nadja Haiden M.D.
Organization
Medical University of Vienna
nadja.haiden@meduniwien.ac.at
+431404003232

Study Officials

  • Nadja Haiden, MD

    Medical university of Vienna, Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc.Prof.MD.

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 24, 2012

Study Start

October 1, 2007

Primary Completion

October 1, 2010

Study Completion

February 1, 2011

Last Updated

July 18, 2014

Results First Posted

July 18, 2014

Record last verified: 2014-06