Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine
January 19, 2022 updated by: Institute of Child Health
Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom, WC1N 1EH
- Institute of Child Health, 30 Guilford Street
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 3 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Infants who have undergone surgical procedures for congenital anomalies or
- Intestinal inflammation who require total parenteral nutrition.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Dipeptiven (L-glutamine- Lalanine)
|
0.6g/kg/day
|
|
Placebo Comparator: 2
Isonitrogenous Vaminolact
|
Isonitrogenous Vaminolact
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evidence of microbial invasion
Time Frame: 5 days
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2009
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
March 26, 2008
First Submitted That Met QC Criteria
March 28, 2008
First Posted (Estimate)
March 31, 2008
Study Record Updates
Last Update Posted (Actual)
January 25, 2022
Last Update Submitted That Met QC Criteria
January 19, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 07SG10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.