A Phase 3 interventional study of Furosemide and Saline in Lung Disease, sponsored by The Hospital for Sick Children. Status unknown at 2 sites in Canada. Open to participants aged 1 Week to 44 Weeks. Per ClinicalTrials.gov, last updated 2008-02-20.
Sponsored by The Hospital for Sick Children · Phase 3, Interventional, and Treatment
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's planned enrollment of 64 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Satisfy one of the following criteria:
Exclusion Criteria:
Furosemide
Drug: Furosemide
Drug: Saline
The dose of furosemide will be 1 mg/kg by intravenous bolus injection
1 mg/kg by intravenous bolus injection
Cardiac chamber volume loading.
Time frame: 4 hours after drug administration and 24 hours post recruitment
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
Myocardial performance, cardiac input and output and pulmonary hemodynamics (echocardiograph exam).
Time frame: 4 hours after drug administration and 24 hours post recruitment
Changes in electrolyte balance, body weight and urine output.
Time frame: 4 hours after drug administration and 24 hours post recruitment
This study is status unknown, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children