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Continuous infusion compared with intermittent flushing to minimize loss of function of iv in neonates.


- candidate number6679
- NTR NumberNTR2107
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-okt-2009
- Secondary IDs 
- Public TitleContinuous infusion compared with intermittent flushing to minimize loss of function of iv in neonates.
- Scientific TitleContinuous infusion compared with intermittent flushing to minimize loss of function of iv for neonates.
- ACRONYM
- hypothesisAn iv that will be flushed intermittendly will not loose his function easier than a continuous iv.
- Healt Condition(s) or Problem(s) studiedNeonates, Iv loss of function
- Inclusion criteria1. Neonates younger that 28 days;
2. Iv for drug administration.
- Exclusion criteriaClinical indication for fluid administration apart from drug administration.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2009
- planned closingdate1-nov-2011
- Target number of participants90
- Interventions1. 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 outcome1. Hours between start iv and loss of function;
2. Amount of iv lines in first 72 hours.
- Secondary outcomeSide effects of continuous iv and flushing such as occlusion, infection and subcutaneous infiltration.
- Timepoints1. No more need for iv drug administration;
2. 72 hours.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Frank Derriks
- CONTACT for SCIENTIFIC QUERIES Frank Derriks
- Sponsor/Initiator VieCuri Medisch Centrum voor Noord-Limburg
- Funding
(Source(s) of Monetary or Material Support)
VieCuri Medisch Centrum voor Noord-Limburg
- Publicationsnone
- Brief summaryComparison 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)
- RECORD30-okt-2009 - 29-nov-2009


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