Clinical Trials Directory

Trials / Unknown

UnknownNCT00618852

Using Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates

A Randomized Controlled Trial of Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
64 (estimated)
Sponsor
The Hospital for Sick Children · Academic / Other
Sex
All
Age
1 Week – 44 Weeks
Healthy volunteers
Not accepted

Summary

The purpose of this study is to investigate the effects of intravenous furosemide on cardio-respiratory performance in neonates receiving a packed red blood cell (PRBC) transfusion who are considered at high risk of volume overload.

Detailed description

Red cell transfusion is a very common practice in neonates, particularly in preterm infants. It has been estimated that approximately 300,000 neonates undergo transfusions annually. The decision to administer a blood transfusion to a sick anemic neonate is made after consideration of multiple clinical factors, including: poor weight gain, oxygenation failure, and recurrent apnea and bradycardia. These decisions are also influenced by physician preferences. For many years, furosemide has been used routinely by physicians during and after blood transfusions in neonates and other age groups. The rationale behind this common practice is to reduce the vascular overload that may be imposed by the additional blood volume delivered during transfusion. This belief, however, lacks the support of scientific clinical evaluation.

Conditions

Interventions

TypeNameDescription
DRUGFurosemideThe dose of furosemide will be 1 mg/kg by intravenous bolus injection
DRUGSaline1 mg/kg by intravenous bolus injection

Timeline

Start date
2007-01-01
Primary completion
2008-12-01
Completion
2009-06-01
First posted
2008-02-20
Last updated
2008-02-20

Locations

2 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT00618852. Inclusion in this directory is not an endorsement.