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

The Hospital for Sick Children

Status and phase: Unknown; Phase 3

Conditions: Lung Disease

Treatments: Drug: Saline; Drug: Furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT00618852

1000009083

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 1 to 44 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Furosemide

Treatment:

Drug: Furosemide

2

Placebo Comparator group

Treatment:

Drug: Saline