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| Tracking Information | |||||
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| First Received Date ICMJE | February 7, 2008 | ||||
| Last Updated Date | February 19, 2008 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Cardiac chamber volume loading. [ Time Frame: 4 hours after drug administration and 24 hours post recruitment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00618852 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Using Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates | ||||
| Official Title ICMJE | A Randomized Controlled Trial of Furosemide to Prevent Fluid Overload During Red Blood Cell Transfusion in Neonates | ||||
| Brief Summary | 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. |
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| Detailed 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. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Lung Disease | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | Experimental: Furosemide | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 64 | ||||
| Estimated Completion Date | June 2009 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 44 Weeks | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00618852 | ||||
| Responsible Party | Patrick McNamara/Principal Investigator, The Hospital for Sick Children | ||||
| Study ID Numbers ICMJE | 1000009083 | ||||
| Study Sponsor ICMJE | The Hospital for Sick Children | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | The Hospital for Sick Children | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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