The effect of heparin on parenteral lipid metabolism and tolerance in newborns
| ISRCTN | ISRCTN32517537 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32517537 |
| Protocol serial number | N0544093489 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrooke's (UK) |
- 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
Scientific
Box No 226
Neonatal Unit
The Rosie Hospital
Cambridge
CB2 2SW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The effects of heparin on intravenous nutrition. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 140 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2000 |
| Date of final enrolment | 31/08/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Box No 226
Cambridge
CB2 2SW
United Kingdom
CB2 2SW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
