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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 26, 2008

Last Updated Date

March 28, 2008

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evidence of microbial invasion [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00647036 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Microbial Invasion During Parenteral Nutrition in Surgical Infants Receiving Glutamine

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)

Condition ^ICMJE

Surgical Infants Requiring Total Parenteral Nutrition

Intervention ^ICMJE

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

Study Arm (s)

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

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Gender

Both

Ages

up to 3 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Agostino Pierro, Prof

a.pierro@ich.ucl.ac.uk

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00647036

Other Study ID Numbers ^ICMJE

07SG10

Has Data Monitoring Committee

Responsible Party

R&D Office, Institute of Child Health

Study Sponsor ^ICMJE

Institute of Child Health

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Institute of Child Health

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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