Condition category
Infections and Infestations
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
14/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Mark Bishay

ORCID ID

Contact details

Institute of Child Health
Paediatric Surgery Unit
30 Guilford Street
London
WC1N 1EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6739

Study information

Scientific title

Acronym

MIGS

Study hypothesis

A prospective single-centre double-blind randomised controlled trial to test the hypothesis that the addition of glutamine to parenteral and enteral feeds leads to a reduction in bacterial invasion in surgical infants requiring parenteral nutrition.

Ethics approval

MREC approved, ref: 08/H0713/31

Study design

Single-centre randomised interventional prevention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Topic: Infection, Generic Health Relevance and Cross Cutting Themes; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology

Intervention

Intervention group:
During the period of partial enteral feeding, in which the parenteral intake of glutamine/placebo is reducing, we will supplement the enteral diet with the balance which is no longer being given parenterally. This glutamine will be given as Adamin-G® (SHS International Ltd, Liverpool, UK).

Control group:
The control group will receive Complete Amino Acid Mix (SHS International Ltd, Liverpool, UK; contains 0.7% glutamine). The control group will receive isonitrogenous Vaminolact® (Fresenius-Kabi, Runcorn, Cheshire, UK; this contains no glutamine).

Parenteral glutamine will be given as a chemically stable dipeptide solution (Dipeptiven®, Fresenius-Kabi, Runcorn, Cheshire, UK; L-alanyl-L-glutamine 200 mg/ml) in a dose of 0.4 g/kg/day glutamine equivalent to 0.6 g/kg/day Dipeptiven®, which ensures that the nitrogen intake of the intervention and control infants is equal and that no more than 35% of the total nitrogen intake will be provided by Dipeptiven®.

Study entry: single randomisation only

Intervention type

Drug

Phase

Not Applicable

Drug names

Glutamine

Primary outcome measures

Positive blood cultures, measured at beginning of trial, 5 days after starting PN, introduction of first enteral feeding, when full enteral feeding

Secondary outcome measures

1. Clinical signs of infection, measured at beginning of trial, 5 days after starting PN, introduction of first enteral feeding, when full enteral feeding
2. Elevated levels of endotoxin, measured at beginning of trial, 5 days after starting PN, introduction of first enteral feeding, when full enteral feeding
3. Intestinal function, measured at beginning of trial, 5 days after starting PN, introduction of first enteral feeding, when full enteral feeding
4. Intestinal permeability, measured at beginning of trial, 5 days after starting PN, introduction of first enteral feeding, when full enteral feeding
5. Level of EndoCAb (endotoxin-core antibodies), measured at beginning of trial, 5 days after starting PN, introduction of first enteral feeding, when full enteral feeding
6. Monocyte HLA-DR expression, measured at beginning of trial, 5 days after starting PN, introduction of first enteral feeding, when full enteral feeding
7. Plasma lipopolysaccharide, measured at beginning of trial, 5 days after starting PN, introduction of first enteral feeding, when enteral feeding
8. Presence of bacterial DNA, measured at beginning of trial, 5 days after starting PN, introduction of first enteral feeding, when full enteral feeding
9. Serum amino acid profile, measured at beginning of trial, 5 days after starting PN, introduction of first enteral feeding, when full enteral feeding

Overall trial start date

21/07/2009

Overall trial end date

20/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Planned sample size: 60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

21/07/2009

Recruitment end date

20/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Child Health
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Great Ormond Street Hospital for Children (UK)

Sponsor details

30 Guilford Street
London
WC1N 1EH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.ich.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

Sparks (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes