INFASURF SUMMARY
Infasurf® (calfactant) Intratracheal Suspension is a sterile, non-pyrogenic lung surfactant intended for intratracheal instillation only. It is an extract of natural surfactant from calf lungs which includes phospholipids, neutral lipids, and hydrophobic surfactant-associated proteins B and C (SP-B and SP-C). It contains no preservatives.
Infasurf is indicated for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment ("rescue") of premature infants who develop RDS. Infasurf decreases the incidence of RDS, mortality due to RDS, and air leaks associated with RDS.
Prophylaxis therapy at birth with Infasurf is indicated for premature infants <29 weeks of gestational age at significant risk for RDS. Infasurf prophylaxis should be administered as soon as possible, preferably within 30 minutes after birth.
Infasurf therapy is indicated for infants </=72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.
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NEWS HIGHLIGHTSMedia Articles Related to Infasurf (Calfactant)
ARDS (Acute Respiratory Distress Syndrome)
Source: MedicineNet Endotracheal Intubation Specialty [2007.03.12]
Title: ARDS (Acute Respiratory Distress Syndrome)
Category: Diseases and Conditions
Created: 3/12/2007
Last Editorial Review: 3/12/2007
Published Studies Related to Infasurf (Calfactant)
Post hoc analysis of calfactant use in immunocompromised children with acute lung injury: Impact and feasibility of further clinical trials. [2008.08.01]
OBJECTIVE:: To assess the impact of calfactant (a modified natural bovine lung surfactant) in immunocompromised children with acute lung injury and to determine the number of patients required for a definitive clinical trial of calfactant in this population... CONCLUSIONS:: These preliminary data suggest a potential benefit of calfactant in this high-risk population. A clinical trial powered to appropriately assess these findings seems warranted and feasible.
A critical appraisal of a randomized controlled trial: Willson et al: Effect of exogenous surfactant (calfactant) in pediatric acute lung injury (JAMA 2005, 293: 470-476). [2007.01]
OBJECTIVE:: To evaluate the use of exogenous surfactant in pediatric acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in decreasing the duration of respiratory failure... CONCLUSIONS:: This is a well-designed study with an appropriate intention-to-treat analysis, but it is underpowered, making it difficult to identify which patients with pediatric ALI/ARDS might benefit from calfactant. Given the uncertainty of the benefits, calfactant cannot be routinely recommended in pediatric ALI/ARDS.
A critical appraisal of a randomized controlled trial: Willson et al: Effect of exogenous surfactant (calfactant) in pediatric acute lung injury (JAMA 2005, 293: 470-476). [2006.12.04]
OBJECTIVE:: To evaluate the use of exogenous surfactant in pediatric acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in decreasing the duration of respiratory failure... CONCLUSIONS:: This is a well-designed study with an appropriate intention-to-treat analysis, but it is underpowered, making it difficult to identify which patients with pediatric ALI/ARDS might benefit from calfactant. Given the uncertainty of the benefits, calfactant cannot be routinely recommended in pediatric ALI/ARDS.
Comparison of Infasurf (calfactant) and Survanta (beractant) in the prevention and treatment of respiratory distress syndrome. [2005.08]
BACKGROUND: In biophysical and animal testing, Infasurf develops lower surface tension and restores total surfactant activity better than Survanta... CONCLUSION: Early trial closure prevents us from either accepting or rejecting our null hypothesis.
Effect of exogenous surfactant (calfactant) in pediatric acute lung injury: a randomized controlled trial. [2005.01.26]
CONTEXT: Despite evidence that patients with acute lung injury (ALI) have pulmonary surfactant dysfunction, trials of several surfactant preparations to treat adults with ALI have not been successful. Preliminary studies in children with ALI have shown that instillation of a natural lung surfactant (calfactant) containing high levels of surfactant-specific protein B may be beneficial. OBJECTIVE: To determine if endotracheal instillation of calfactant in infants, children, and adolescents with ALI would shorten the course of respiratory failure... CONCLUSIONS: Calfactant acutely improved oxygenation and significantly decreased mortality in infants, children, and adolescents with ALI although no significant decrease in the course of respiratory failure measured by duration of ventilator therapy, intensive care unit, or hospital stay was observed.
Clinical Trials Related to Infasurf (Calfactant)
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide [Recruiting]
The purpose of this study is to determine if the combination of late doses of Infasurf with
inhaled nitric oxide will interact to improve the surfactant function and thus the
respiratory status and outcome of treated infants.
Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With Respiratory Decompensation [Completed]
The purpose of the study is to determine whether additional surfactant(Infasurf) doses at 7
to 10 days of life time will improve lung function in premature infants, allowing a decrease
in required oxygen concentration and ventilator settings.
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates [Completed]
A research study that will evaluate if giving surfactant medication to premature babies
weighing < 1250 gm at birth during the second and third weeks of life will help their lungs.
We are enrolling those premature babies who continue to require the breathing tube and the
mechanical ventilator at days 7-10 of life.
Calfactant for Direct Acute Respiratory Distress Syndrome [Recruiting]
This study will determine if administration of an suspension of calfactant, a lung
surfactant, intratracheally in patients with Direct Acute Respiratory Distress Syndrome
within 48 hours of requiring mechanical ventilation can decrease the mortality in patients
with lethal disease and shorten the course of respiratory failure in patients with
sub-lethal disease.
The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study [Recruiting]
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