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Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Institute of Child Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00647036
First received: March 26, 2008
Last updated: March 28, 2008
Last verified: March 2008
  Purpose

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 (Subject, 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 ] [ Designated as safety issue: No ]

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)
0.6g/kg/day
Placebo Comparator: 2
Isonitrogenous Vaminolact
Dietary Supplement: Isonitrogenous Vaminolact
Isonitrogenous Vaminolact

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647036

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

Locations
United Kingdom
Institute of Child Health, 30 Guilford Street Not yet recruiting
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

No publications provided

Responsible Party: R&D Office, Institute of Child Health
ClinicalTrials.gov Identifier: NCT00647036     History of Changes
Other Study ID Numbers: 07SG10
Study First Received: March 26, 2008
Last Updated: March 28, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Institute of Child Health:
Parenteral nutrition, Infants, Dipeotiven, Microbial invasion

ClinicalTrials.gov processed this record on November 27, 2014