The effect on clinical outcome of glutamine supplementation of parenteral nutrition in the surgical newborn infant

ISRCTN	ISRCTN83168963
DOI	https://doi.org/10.1186/ISRCTN83168963
Secondary identifying numbers	SP3763

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Agostino Pierro
Scientific

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

Phone	+44 (0)20 7272 2814
Email	SIGN.Trial@ich.ucl.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	SIGN (Surgical Infants Glutamine Nutrition)
Study objectives	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(s)	Ethics approval received from local medical ethics committee (ref: 2/4/002).
Health condition(s) or problem(s) studied	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
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 study start date	01/04/2002
Completion date	30/09/2004

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	250
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2002
Date of final enrolment	30/09/2004

Paediatric Surgery Unit

London
WC1N 1EH
United Kingdom

Action Medical Research (UK)
Charity

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Website	http://www.action.org.uk/
"ROR"	https://ror.org/01wcqa315

Charity

Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): actionmedres, action medical research for children, AMR
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2012		Yes	No