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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Furosemide |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | The dose of furosemide will be 1 mg/kg by intravenous bolus injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac chamber volume loading. | 4 hours after drug administration and 24 hours post recruitment |
| 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). |
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Inclusion Criteria:
Less than 44 weeks corrected gestational age
Receiving a red cell transfusion
Satisfy one of the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick McNamara, MD | Contact | 416-813-5773 | patrick.mcnamara@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| Patrick McNamara, MD | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Recruiting | Toronto | Ontario | M5G 1X5 | Canada |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D004487 | Edema |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Saline |
| Drug |
1 mg/kg by intravenous bolus injection |
|
| 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 |
| The Hospital for Sick Children | Not yet recruiting | Toronto | Ontario | M5G 1X8 | Canada |
|
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |