Prospective, randomised, double-blind trial of heparin or 0.45% saline infusion through the long line to reduce the incidence of long line sepsis in very low birth-weight infants

ISRCTN	ISRCTN70684741
DOI	https://doi.org/10.1186/ISRCTN70684741
Protocol serial number	06/Q0403/14
Sponsor	St Mary's Hospital (UK)
Funder	St Mary's Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Sunit Godambe
Scientific

St Mary's Hospital
Bays Building
Praed Street
Paddington
London
W2 1NY
United Kingdom

Phone	+44 (0)207 8863791
Email	sunit.godambe@st-marys.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Prospective, randomised, double-blind trial of heparin or 0.45% saline infusion through the long line to reduce the incidence of long line sepsis in very low birth-weight infants
Study acronym	HILL study
Study objectives	Intravenous heparin infusion reduces bacterial adherence in long lines by reducing fibronectin deposition and thereby reducing the incidence of long line sepsis.
Ethics approval(s)	St Mary's Local Research Committee, 11/05/2006, ref: 06/Q0403/14
Health condition(s) or problem(s) studied	Long line infections in very low birth-weight (VLBW) infants
Intervention	The trial has started enrolling patients from 1st September 2007. Heparin infusion in long line versus placebo (0.45% saline infusion).
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Heparin
Primary outcome measure(s)	1. Reduction in the rate of long line infections 2. Increase in the longevity of long lines 3. Reduction in the number of long lines used 4. To record any adverse effects e.g. bleeding tendencies associated with the use of heparin
Key secondary outcome measure(s)	1. Reduction in catheter-related thromboses
Completion date	31/07/2009

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	128
Key inclusion criteria	Infants admitted to Winnicott Baby Unit (Neonatal Intensive Care Unit [NICU]), St Mary's Hospital and born with birth weight <1500 g and who need a long line inserted for any medical indication and for whom written parental consent has been obtained are eligible to enter the study. Each baby can be enrolled only once in the study - the same infant will not be enrolled for the study again if he/she needs another long line inserted and if he/she has already been in the study before.
Key exclusion criteria	1. Infants who have a persisting haemorrhagic diathesis at time of proposed insertion of long line (LL). (International normalised ratio [INR] >1.8, activited partial thromboplastin time [APTT] >79.4 sec: Andrew M, et al 1988. Blood 72:1651-7) 2. Infants for whom parents have refused consent 3. Infants with birth weight ≥1500 g 4. Infants who have a ≥grade 3 intraventricular haemorrhage, unilaterally or bilaterally (by Papille's classification) 5. Infants with culture proven infection within 48 hours prior to long line insertion 6. Infants with platelet counts <100 x 10^9/l 7. Infants who are deemed clinically unstable by the attending clinician but not from getting a LL
Date of first enrolment	01/08/2006
Date of final enrolment	31/07/2009

St Mary's Hospital, Bays Building

London
W2 1NY
United Kingdom

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

27/04/2016: No publications found, verifying study status with principal investigator