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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Disease

Intervention / Treatment
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* Drug: Furosemide
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 44 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Furosemide | Drug: Furosemide<br>* The dose of furosemide will be 1 mg/kg by intravenous bolus injection<br>|
| Placebo Comparator: 2<br> | Drug: Saline<br>* 1 mg/kg by intravenous bolus injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac chamber volume loading. |  | 4 hours after drug administration and 24 hours post recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cardio-respiratory stability (heart rate, blood pressure, respiratory rate, oxygen saturation, and oxygen requirement). |  | 4 hours after drug administration and 24 hours post recruitment | 
| Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam). |  | 4 hours after drug administration and 24 hours post recruitment | 
| Changes in electrolyte balance, body weight and urine output. |  | 4 hours after drug administration and 24 hours post recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Erythrocyte Transfusion, Furosemide, Fluid Overload