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

Not Applicable

Completed

Conditions: ong line infections in very low birth-weight (VLBW) infants
Neonatal Diseases
Sepsis

Registration Number: ISRCTN70684741

Lead Sponsor: St Mary's Hospital (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 128

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.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Reduction in the rate of long line infections<br>2. Increase in the longevity of long lines<br>3. Reduction in the number of long lines used<br>4. To record any adverse effects e.g. bleeding tendencies associated with the use of heparin

Secondary Outcome Measures