The effect of heparin on parenteral lipid metabolism and tolerance in newborns

ISRCTN ISRCTN32517537
DOI https://doi.org/10.1186/ISRCTN32517537
Secondary identifying numbers N0544093489
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
07/11/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
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

Contact information

Dr Robert J McClure
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThe effects of heparin on intravenous nutrition.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNeonatal Diseases: Lipid metabolism
Intervention1. 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2000
Completion date31/08/2004

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants140 subjects
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/2000
Date of final enrolment31/08/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Box No 226
Cambridge
CB2 2SW
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Cambridge Consortium - Addenbrooke's (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan