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

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:

Drug Information available for: Glutamine Parenteral Nutrition, Total

U.S. FDA Resources

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

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 June 18, 2013

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