Condition category
Surgery
Date applied
30/04/2003
Date assigned
30/04/2003
Last edited
09/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.action.org.uk/

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

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

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22513659

Publication citations

  1. 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.

Additional files

Editorial Notes