Microbial invasion during parenteral nutrition in surgical infants receiving glutamine

ISRCTN	ISRCTN54742344
DOI	https://doi.org/10.1186/ISRCTN54742344
ClinicalTrials.gov (NCT)	NCT00647036
Protocol serial number	6739
Sponsor	Great Ormond Street Hospital for Children (UK)
Funder	Sparks (UK)

Submission date: 19/05/2010
Registration date: 19/05/2010
Last edited: 29/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Mark Bishay
Scientific

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

Study information

Primary study design	Interventional
Study design	Single-centre randomised interventional prevention trial
Secondary study design	Randomised controlled trial
Scientific title	Microbial invasion during parenteral nutrition in surgical infants receiving glutamine
Study acronym	MIGS
Study objectives	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(s)	MREC approved, ref: 08/H0713/31
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Glutamine
Primary outcome measure(s)	Positive blood cultures, measured at beginning of trial, 5 days after starting PN, introduction of first enteral feeding, when full enteral feeding
Key secondary outcome measure(s)	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
Completion date	20/07/2011

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	60
Total final enrolment	60
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	21/07/2009
Date of final enrolment	20/07/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Child Health

London
WC1N 1EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2020	29/12/2020	Yes	No

Editorial Notes

29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
09/09/2019: ClinicalTrials.gov number added.
20/04/2017: No publications found in PubMed, verifying study status with principal investigator.