Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine
Sponsor
Institute of Child Health (Other)
Overall Status
Completed
CT.gov ID
NCT00647036
Collaborator
(none)
60
1
2
34
1.8
Study Details
Study Description
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 |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine.
Actual Study Start Date
:
Jul 1, 2009
Actual Primary Completion Date
:
Dec 1, 2011
Actual Study Completion Date
:
May 1, 2012
Arms and Interventions
| 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
Primary Outcome Measures
- Evidence of microbial invasion [5 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 3 Months
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Child Health, 30 Guilford Street | London | United Kingdom | WC1N 1EH |
Sponsors and Collaborators
- Institute of Child Health
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00647036
Other Study ID Numbers:
- 07SG10
First Posted:
Mar 31, 2008
Last Update Posted:
Jan 25, 2022
Last Verified:
Jan 1, 2022
Keywords provided by Institute of Child Health