Recruiting
Phase 3

Furosemide

Sponsor:

The Hospital for Sick Children

Code:

NCT00618852

Conditions

Lung Disease

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Furosemide

Saline

Study Details

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.

Conditions

Lung Disease

Study ID

NCT00618852

Start date

Jan, 2007

Status verified date

Feb, 2008

Completion date

Jun, 2009

Anticipated

Primary completion date

Dec, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

Furosemide

placebo comparator: 2

Interventions

Furosemide

The dose of furosemide will be 1 mg/kg by intravenous bolus injection

Saline

1 mg/kg by intravenous bolus injection

Primary outcome measure

  • Cardiac chamber volume loading. [ Time Frame: 4 hours after drug administration and 24 hours post recruitment ]

Central Contacts and Locations

Central contacts

Patrick McNamara, MD

416-813-5773patrick.mcnamara@sickkids.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Edmond Kelley, MD

416-586-5310ekelly@mtsinai.on.ca

Principal Investigator:

Edmond Kelley, MD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Feb 20, 2008

Last verified

Feb, 2008

Keywords

  • Pediatrics
  • Erythrocyte Transfusion
  • Furosemide
  • Fluid Overload

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2008-02-20.