Condition category
Neonatal Diseases
Date applied
08/05/2006
Date assigned
26/05/2006
Last edited
27/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sunit Godambe

ORCID ID

Contact details

St Mary's Hospital
Bays Building
Praed Street
Paddington
London
W2 1NY
United Kingdom
+44 (0)207 8863791
sunit.godambe@st-marys.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06/Q0403/14

Study information

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

Acronym

HILL study

Study hypothesis

Intravenous heparin infusion reduces bacterial adherence in long lines by reducing fibronectin deposition and thereby reducing the incidence of long line sepsis.

Ethics approval

St Mary's Local Research Committee, 11/05/2006, ref: 06/Q0403/14

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

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 names

Heparin

Primary outcome measures

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

Secondary outcome measures

1. Reduction in catheter-related thromboses

Overall trial start date

01/08/2006

Overall trial end date

31/07/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

128 very low birth-weight (VLBW) infants

Participant 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

Recruitment start date

01/08/2006

Recruitment end date

31/07/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Mary's Hospital, Bays Building
London
W2 1NY
United Kingdom

Sponsor information

Organisation

St Mary's Hospital (UK)

Sponsor details

Praed Street
Paddington
London
W2 1NY
United Kingdom
+44 (0)207 8866666
ros.cooke@st-marys.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

St Mary's Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes

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