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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Furosemide
  • The dose of furosemide will be 1 mg/kg by intravenous bolus injection
• Drug: Saline
  • 1 mg/kg by intravenous bolus injection

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Furosemide
• Placebo Comparator: 2

Primary Measures

• Cardiac chamber volume loading.
  • Time Frame: 4 hours after drug administration and 24 hours post recruitment
    Safety Issue?: No

Secondary Measures

• Clinical cardio-respiratory stability (heart rate, blood pressure, respiratory rate, oxygen saturation, and oxygen requirement).
  • Time Frame: 4 hours after drug administration and 24 hours post recruitment
    Safety Issue?: No
• Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam).
  • Time Frame: 4 hours after drug administration and 24 hours post recruitment
    Safety Issue?: No
• Changes in electrolyte balance, body weight and urine output.
  • Time Frame: 4 hours after drug administration and 24 hours post recruitment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 44 Weeks

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: The Hospital for Sick Children

Overall Clinical Trial Officials and Contacts

Patrick McNamara, MD Principal Investigator The Hospital for Sick Children, Toronto Canada  

Overall Contact: Patrick McNamara, MD 416-813-5773 patrick.mcnamara@sickkids.ca

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00618852

Study ID Number: 1000009083

ClinicalTrials.gov Identifier: NCT00618852

Health Authority: Canada: Health Canada