Condition category
Neonatal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
07/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert J McClure

ORCID ID

Contact details

Box No 226
Neonatal Unit
The Rosie Hospital
Cambridge
CB2 2SW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544093489

Study information

Scientific title

Acronym

Study hypothesis

The effects of heparin on intravenous nutrition.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Neonatal Diseases: Lipid metabolism

Intervention

1. Parenteral nutrition with heparin
2. Parenteral nutrition without heparin

Heparin is commonly added to the infusions of neonatal patients, to prevent line blockage. This study is to determine whether the addition of heparin to parenteral nutrition (PN) infusions both allows lipid intake to be safely increased and central line complications to be reduced in ill newborn infants requiring PN. The hypothesis is that heparin added to a PN regimen using 20% Intralipid will allow increased lipid, calorie intake and reduced central line complications without increasing serum free fatty acids (FFA), thyroglobulin (TG) or cholesterol to unacceptable levels. Infants that require PN will be randomised in pharmacy (on receipt of first PN order) to receive PN either with or without heparin added at a dosage of 1 unit/ml Vamin-J amino acid solution. PN will be prescribed as usual according to unit policy. Attending medical and nursing staff on the neonatal unit will be blind to whether PN contains heparin.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2000

Overall trial end date

31/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

140 subjects

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2000

Recruitment end date

31/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box No 226
Cambridge
CB2 2SW
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrooke's (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