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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN70684741
Enrollment
128
Registered
2006-05-26
Start date
2006-08-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long line infections in very low birth-weight (VLBW) infants Neonatal Diseases Sepsis

Interventions

The trial has started enrolling patients from 1st September 2007. Heparin infusion in long line versus placebo (0.45% saline infusion).

Sponsors

St Mary's Hospital (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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 LL

Design outcomes

Primary

MeasureTime frame
1. Reduction in the rate of long line infections 2. Increase in the longevity of long lines 3. Reduction in the number of long lines used 4. To record any adverse effects e.g. bleeding tendencies associated with the use of heparin

Secondary

MeasureTime frame
1. Reduction in catheter-related thromboses

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026