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Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine

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ClinicalTrials.gov Identifier: NCT00647036
Recruitment Status : Unknown
Verified March 2008 by Institute of Child Health.
Recruitment status was:  Not yet recruiting
First Posted : March 31, 2008
Last Update Posted : March 31, 2008
Sponsor:
Information provided by:
Institute of Child Health

Tracking Information
First Submitted Date  ICMJE March 26, 2008
First Posted Date  ICMJE March 31, 2008
Last Update Posted Date March 31, 2008
Study Start Date  ICMJE July 2008
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2008)
Evidence of microbial invasion [ Time Frame: 5 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine
Official Title  ICMJE Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine.
Brief Summary We hypothesise that the addition of glutamine supplementation to both parenteral nutrition and enteral feeds in surgical newborn infants leads to a reduction in bacterial invasion.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Surgical Infants Requiring Total Parenteral Nutrition
Intervention  ICMJE
  • Dietary Supplement: Isonitrogenous Vaminolact
    Isonitrogenous Vaminolact
  • Drug: Dipeptiven (L-glutamine- Lalanine)
    0.6g/kg/day
Study Arms  ICMJE
  • Active Comparator: 1
    Dipeptiven (L-glutamine- Lalanine)
    Intervention: Drug: Dipeptiven (L-glutamine- Lalanine)
  • Placebo Comparator: 2
    Isonitrogenous Vaminolact
    Intervention: Dietary Supplement: Isonitrogenous Vaminolact
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 28, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infants who have undergone surgical procedures for congenital anomalies or
  • Intestinal inflammation who require total parenteral nutrition.

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00647036
Other Study ID Numbers  ICMJE 07SG10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R&D Office, Institute of Child Health
Study Sponsor  ICMJE Institute of Child Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institute of Child Health
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP