Status:
UNKNOWN
Using Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Lung Disease
Eligibility:
All Genders
1-44 years
Phase:
PHASE3
Brief 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 ...
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 ad...
Eligibility Criteria
Inclusion
- Less than 44 weeks corrected gestational age
- Receiving a red cell transfusion
- Satisfy one of the following criteria:
- Echocardiographic evidence of a hemodynamically significant ductus arteriosus (HSDA) defined by a transductal diameter \>1.5 mm and unrestrictive systemic-pulmonary trans-ductal flow
- Clinical evidence of significant lung disease defined by a need for respiratory support (assisted ventilation or nasal CPAP) and oxygen supplementation after 28 days of age
Exclusion
- Infants with multiple congenital anomalies or renal insufficiency
- Infants with hypotension, hypertension, or on any cardiac medication
- Infants with sepsis causing compromised clinical condition such as disseminated intravascular coagulopathy
- Infants with contra-indications to diuretic therapy, such as significant electrolyte imbalance, or endocrine disease
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00618852
Start Date
January 1 2007
End Date
June 1 2009
Last Update
February 20 2008
Active Locations (2)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
2
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8