|- candidate number||6679|
|- NTR Number||NTR2107|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-okt-2009|
|- Secondary IDs|| |
|- Public Title||Continuous infusion compared with intermittent flushing to minimize loss of function of iv in neonates.|
|- Scientific Title||Continuous infusion compared with intermittent flushing to minimize loss of function of iv for neonates.|
|- hypothesis||An iv that will be flushed intermittendly will not loose his function easier than a continuous iv.|
|- Healt Condition(s) or Problem(s) studied||Neonates, Iv loss of function|
|- Inclusion criteria||1. Neonates younger that 28 days; |
2. Iv for drug administration.
|- Exclusion criteria||Clinical indication for fluid administration apart from drug administration.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2009|
|- planned closingdate||1-nov-2011|
|- Target number of participants||90|
|- Interventions||1. Continuous iv glucose 5% 2ml/h;|
2. Continuous iv glucose 5% 1ml/h;
3. Iv flushed 4 times a day with 2 ml NaCl 0,9%.
|- Primary outcome||1. Hours between start iv and loss of function;|
2. Amount of iv lines in first 72 hours.
|- Secondary outcome||Side effects of continuous iv and flushing such as occlusion, infection and subcutaneous infiltration.|
|- Timepoints||1. No more need for iv drug administration;|
2. 72 hours.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Frank Derriks|
|- CONTACT for SCIENTIFIC QUERIES|| Frank Derriks|
|- Sponsor/Initiator ||VieCuri Medisch Centrum voor Noord-Limburg|
(Source(s) of Monetary or Material Support)
|VieCuri Medisch Centrum voor Noord-Limburg|
|- Brief summary||Comparison of loss of function between continuous iv and intermittend flushing in neonates who need an iv for drug administration.|
We expect no difference in loss of function time between continuous iv and intermittend flushing.
Other studies only compared intermittend flushing with NaCl/Heparine versus continuous glucose 10%. Seen the risk for flebitis using concentrated glucose solution we hypothesise a better outcome using glucose 5%. Because recent study shows flushing with heparin is as effective as flushing with NaCl 0,9% we use NaCl 0,9%.
|- Main changes (audit trail)|
|- RECORD||30-okt-2009 - 29-nov-2009|