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
| Type | Name | Description |
|---|---|---|
| DRUG | Furosemide | The dose of furosemide will be 1 mg/kg by intravenous bolus injection |
| DRUG | Saline | 1 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.