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Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by Institute of Child Health.
Recruitment status was:  Not yet recruiting
Information provided by:
Institute of Child Health Identifier:
First received: March 26, 2008
Last updated: March 28, 2008
Last verified: March 2008
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 Intervention Phase
Surgical Infants Requiring Total Parenteral Nutrition
Dietary Supplement: Isonitrogenous Vaminolact
Drug: Dipeptiven (L-glutamine- Lalanine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Official Title: Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine.

Resource links provided by NLM:

Further study details as provided by Institute of Child Health:

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

Estimated Enrollment: 60
Study Start Date: July 2008
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Dipeptiven (L-glutamine- Lalanine)
Drug: Dipeptiven (L-glutamine- Lalanine)
Placebo Comparator: 2
Isonitrogenous Vaminolact
Dietary Supplement: Isonitrogenous Vaminolact
Isonitrogenous Vaminolact


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

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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Please refer to this study by its identifier: NCT00647036

Contact: Agostino Pierro, Prof

United Kingdom
Institute of Child Health, 30 Guilford Street Not yet recruiting
London, United Kingdom, WC1N 1EH
Contact: Agostino Pierro, Prof   
Principal Investigator: Agostino Pierro, Prof         
Sponsors and Collaborators
Institute of Child Health
  More Information

Responsible Party: R&D Office, Institute of Child Health Identifier: NCT00647036     History of Changes
Other Study ID Numbers: 07SG10
Study First Received: March 26, 2008
Last Updated: March 28, 2008

Keywords provided by Institute of Child Health:
Parenteral nutrition, Infants, Dipeotiven, Microbial invasion processed this record on May 25, 2017