Plain English Summary
Not provided at time of registration
Trial website
http://www.ich.ucl.ac.uk/ich/html/academicunits/surgery/sign2/signindex.html
Contact information
Type
Scientific
Primary contact
Dr Agostino Pierro
ORCID ID
Contact details
Paediatric Surgery Unit
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7272 2814
SIGN.Trial@ich.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SP3763
Study information
Scientific title
Acronym
SIGN (Surgical Infants Glutamine Nutrition)
Study hypothesis
We will test the hypothesis that glutamine supplementation in the parenteral nutrition (PN) of surgical infants determines more rapid recovery of intestinal function and reduction in infection rate.
Ethics approval
Ethics approval received from local medical ethics committee (ref: 2/4/002).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgical newborn infants on parenteral nutrition
Intervention
The treatment group will receive glutamine-supplemented parenteral nutrition.
The control group will receive isonitrogenous parenteral nutrition.
All patients will have data collected once a week on clinical state, feeding, liver and renal function tests, ammonia, septic episodes and parenteral nutrition lines
Intervention type
Supplement
Phase
Not Applicable
Drug names
Glutamine supplementation
Primary outcome measure
1. Infection: episodes of sepsis and septicaemia, timing of sepsis and septicaemia
2. Intestinal function: time to full enteral feeding and time on (days)
Secondary outcome measures
1. Growth
2. Nutrient intake
3. Biochemical measures of hepatic function
Overall trial start date
01/04/2002
Overall trial end date
30/09/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Surgical infants below the age of 3 months, either sex
2. Require parenteral nutrition
3. Have received less than 5 days of parenteral nutrition already
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
250
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/04/2002
Recruitment end date
30/09/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Paediatric Surgery Unit
London
WC1N 1EH
United Kingdom
Sponsor information
Organisation
Action Medical Research (UK)
Sponsor details
Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Action Medical Research (UK)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
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
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22513659
Publication citations
-
Results
Ong EG, Eaton S, Wade AM, Horn V, Losty PD, Curry JI, Sugarman ID, Klein NJ, Pierro A, , Randomized clinical trial of glutamine-supplemented versus standard parenteral nutrition in infants with surgical gastrointestinal disease., Br J Surg, 2012, 99, 7, 929-938, doi: 10.1002/bjs.8750.