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
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