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Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Surgical Infants Requiring Total Parenteral Nutrition Dietary Supplement: Isonitrogenous Vaminolact Drug: Dipeptiven (L-glutamine- Lalanine) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine.
Study Start Date : July 2008
Estimated Primary Completion Date : July 2010

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Dipeptiven (L-glutamine- Lalanine)
 Drug: Dipeptiven (L-glutamine- Lalanine)
0.6g/kg/day
Placebo Comparator: 2
Isonitrogenous Vaminolact
 Dietary Supplement: Isonitrogenous Vaminolact
Isonitrogenous Vaminolact


Outcome Measures
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Primary Outcome Measures :
  1. Evidence of microbial invasion [ Time Frame: 5 days ]

Eligibility Criteria
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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647036


Contacts
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Contact: Agostino Pierro, Prof a.pierro@ich.ucl.ac.uk

Locations
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United Kingdom
Institute of Child Health, 30 Guilford Street
London, United Kingdom, WC1N 1EH
Contact: Agostino Pierro, Prof       a.pierro@ich.ucl.ac.uk   
Principal Investigator: Agostino Pierro, Prof         
Sponsors and Collaborators
Institute of Child Health
More Information
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Responsible Party: R&D Office, Institute of Child Health
ClinicalTrials.gov Identifier: NCT00647036    
Other Study ID Numbers: 07SG10
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: March 31, 2008
Last Verified: March 2008
Keywords provided by Institute of Child Health:
Parenteral nutrition, Infants, Dipeotiven, Microbial invasion