Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine

• ClinicalTrials.gov Identifier: NCT00647036
• Recruitment Status: Unknown
• First Posted: March 31, 2008
• Last Update Posted: March 31, 2008
• Sponsor: Institute of Child Health
• Information provided by: Institute of Child Health

Tracking Information

• First Submitted Date: March 26, 2008
• First Posted Date: March 31, 2008
• Last Update Posted Date: March 31, 2008
• Study Start Date: July 2008
• Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 28, 2008): Evidence of microbial invasion [ Time Frame: 5 days ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator)
• Condition: Surgical Infants Requiring Total Parenteral Nutrition

Intervention

• Dietary Supplement: Isonitrogenous Vaminolact
  Isonitrogenous Vaminolact
• Drug: Dipeptiven (L-glutamine- Lalanine)
  0.6g/kg/day

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 28, 2008): 60
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 3 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00647036
• Other Study ID Numbers: 07SG10
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: R&D Office, Institute of Child Health
• Study Sponsor: Institute of Child Health
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Institute of Child Health
• Verification Date: March 2008