Abstract
BackgroundFurosemide is approved in full term neonates to treat edema associated with congestive heart failure, cirrhosis and renal diseases. It is often administered off-label in premature neonates, to treat respiratory conditions and at doses greater-than-recommended. We conducted a national survey on behalf of the Neonatal Pharmacotherapy Study Group of the Italian Society of Neonatology (SIN), to investigate its use in Italian neonatal intensive care units (NICUs), in conformity with current guidelines.MethodsBetween December 2016 and June 2017, a 14-item multiple-choice online questionnaire was sent to all NICU directors from the SIN directory.Gestational age, route of administration, posology, indications, referenced guidelines, adverse effects monitoring and the presence of Paediatric Cardiology or Cardiosurgery service on site were assessed. A chi-square test was performed 1) to evaluate differences in the distribution of responses between NICUs administering furosemide at doses higher-than-recommended; 2) to compare the proportion of NICUs administering furosemide at high doses in institutions with versus without a Paediatric Cardiology or Cardiosurgery service.ResultsThe response rate was 50% (57/114). The intravenous and oral routes were chosen primarily; the intravenous administration in single doses predominated over continuous infusion. Its main therapeutic indications were congestive heart failure/overload (94.7%) and oligo-anuria (87.7%) however furosemide was also frequently used for broncopulmonary dysplasia (50.9%) and respiratory distress syndrome and/or transient tachypnea of the newborn (24.6%).In 28/57 NICUs furosemide was administered at doses higher-than-recommended. In most NICUs the same posology was used in term and preterm neonates. Compared to the total sample, a larger proportion of NICUs administering doses greater-than-recommended referenced current literature for reasons to do so (19.3 and 32.1% respectively). The presence of a Paediatric Cardiology or Cardiosurgery service on site did not correlate with the chosen posology.The majority of NICUs performed acoustic test and renal ultrasound for furosemide exposure greater than 2 weeks.ConclusionsIn Italian NICUs, furosemide is commonly prescribed to term and preterm newborns for label and unlabeled indications. Doses greater-than-recommended are frequently administered. Such use is not necessarily inappropriate. More research is required to assess the efficacy and safety of unlabeled use.
Highlights
Furosemide is approved in full term neonates to treat edema associated with congestive heart failure, cirrhosis and renal diseases
Furosemide is approved by the Food and Drug Administration (FDA) and by the Italian Medicines Agency (AIFA) for the treatment of edema associated with congestive heart failure, hepatic cirrhosis and nephrotic syndrome
In Neonatal Intensive Care Units (NICUs) the administration of furosemide is extended to the off-label treatment of respiratory conditions of preterm and term neonates including bronchopulmonary dysplasia (BPD), respiratory distress syndrome (RDS), and the transitory tachypnea of the newborn (TTN) [6,7,8,9]
Summary
Furosemide is approved in full term neonates to treat edema associated with congestive heart failure, cirrhosis and renal diseases It is often administered off-label in premature neonates, to treat respiratory conditions and at doses greater-than-recommended. Furosemide is approved by the Food and Drug Administration (FDA) and by the Italian Medicines Agency (AIFA) for the treatment of edema associated with congestive heart failure, hepatic cirrhosis and nephrotic syndrome. In Neonatal Intensive Care Units (NICUs) the administration of furosemide is extended to the off-label treatment of respiratory conditions of preterm and term neonates including bronchopulmonary dysplasia (BPD), respiratory distress syndrome (RDS), and the transitory tachypnea of the newborn (TTN) [6,7,8,9]. Maximum oral daily doses greater than 40 mg (AIFA) or 6 mg/kg (FDA) are not recommended
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