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Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants

This study has been completed.
Information provided by (Responsible Party):
Nadja Haiden,MD, Medical University of Vienna Identifier:
First received: January 10, 2012
Last updated: June 17, 2014
Last verified: June 2014
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Meconium Ileus
Very Low Birth Weight Infant
Interventions: Drug: Gastrografin
Drug: Sterile water

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
3 year study period 789 infants were eligible for enrollment in the study

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
Gastrografin infants received 3ml/kg Gastrografin + 6ml/kg sterile water once during the first 24 hours of life via gastric tube
Sterile Water infants received 9ml/kg sterile water once during the first 24 hours of life via gastric tube

Participant Flow:   Overall Study
    Gastrografin     Sterile Water  
STARTED     47     49  
COMPLETED     39     39  
NOT COMPLETED     8     10  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Gastrografin infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
Sterile Water infants receive 9ml/kg sterile water
Total Total of all reporting groups

Baseline Measures
    Gastrografin     Sterile Water     Total  
Number of Participants  
[units: participants]
  47     49     96  
[units: participants]
<=18 years     47     49     96  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
[units: participants]
Female     27     20     47  
Male     20     29     49  
Region of Enrollment  
[units: participants]
Austria     47     49     96  
[units: grams]
Median (Full Range)
  (490 to 1440)  
  (480 to 1414)  
  (480 to 1440)  

  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Feeding Tolerance- Full Enteral Feedings   [ Time Frame: days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg ]

3.  Post-Hoc:   Necrotizing Enterocolitis   [ Time Frame: End of study ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Nadja Haiden M.D.
Organization: Medical University of Vienna
phone: +431404003232

Responsible Party: Nadja Haiden,MD, Medical University of Vienna Identifier: NCT01515696     History of Changes
Other Study ID Numbers: 27112001
2007-000851-33 ( EudraCT Number )
Study First Received: January 10, 2012
Results First Received: October 29, 2013
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety