MedPath

Calfactant

Generic Name
Calfactant
Brand Names
Infasurf
Drug Type
Small Molecule
Chemical Formula
-
CAS Number
183325-78-2
Unique Ingredient Identifier
Q4K217VGA9
Background

Calfactant is a sterile, non-pyrogenic lung surfactant intended for intratracheal instillation. It is an off-white suspension of an extract of natural surfactant from calf lungs suspended in 0.9% saline. Each milliliter of calfactant contains 35mg of phospholipids (including 26 mg phosphatidylcholine of which 16 mg is disaturated phosphatidylcholine) and 0.65mg of proteins including surfactant-associated proteins B and C.

Calfactant is approved for use in the United States of America. It is used to prevent or treat respiratory distress syndrome in premature infants with lung surfactant deficiency. Calfactant has been shown to decrease the incidence of respiratory distress syndrome, mortality due to respiratory distress syndrome, and air leaks associated with respiratory distress syndrome in clinical trials. It adsorbs to the air:fluid interface in the lungs and works to reduce surface tension, in a manner similar to endogenous pulmonary surfactant.

Indication

用于预防和治疗早产儿呼吸窘迫综合征(RDS)。

Associated Conditions
Respiratory Distress Syndrome
Associated Therapies
-

Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS

Phase 1
Recruiting
Conditions
Neutrophil Extracellular Trap Formation
Inflammatory Response
Preterm Birth
Neonatal Respiratory Distress Syndrome
Premature Lungs
Interventions
First Posted Date
2024-04-16
Last Posted Date
2024-04-16
Lead Sponsor
Ain Shams University
Target Recruit Count
60
Registration Number
NCT06367881
Locations
🇪🇬

Egypt Neonatal Intensive Care Units (NICUs), Ain Shams University Cairo, Abbasia, Egypt, 11517, Cairo, Egypt

A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact

Phase 2
Completed
Conditions
Respiratory Distress Syndrome in Premature Infant
Interventions
Other: nCPAP
Drug: AeroFact
First Posted Date
2019-05-31
Last Posted Date
2024-08-06
Lead Sponsor
Aerogen Pharma Limited
Target Recruit Count
261
Registration Number
NCT03969992
Locations
🇺🇸

University of Illinois, Chicago, Illinois, United States

🇺🇸

University of Washington, Seattle, Washington, United States

🇺🇸

Children's Hospital of San Antonio (CHofSA), San Antonio, Texas, United States

and more 32 locations

Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome

Not Applicable
Completed
Conditions
Respiratory Distress Syndrome
Interventions
First Posted Date
2016-07-15
Last Posted Date
2017-06-06
Lead Sponsor
University of Missouri-Columbia
Target Recruit Count
30
Registration Number
NCT02834624
Locations
🇺🇸

University of Missouri, Women's and Children's Hospital, Columbia, Missouri, United States

Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.

Phase 2
Conditions
Bronchopulmonary Dysplasia
Interventions
First Posted Date
2010-12-29
Last Posted Date
2010-12-29
Lead Sponsor
East Carolina University
Target Recruit Count
45
Registration Number
NCT01268215
Locations
🇺🇸

NICU-Pitt County Memorial Hospital, Greenville, North Carolina, United States

CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients

Phase 2
Completed
Conditions
Acute Lung Injury
Interventions
Other: Air placebo
Drug: Calfactant
First Posted Date
2009-10-22
Last Posted Date
2018-03-16
Lead Sponsor
Milton S. Hershey Medical Center
Target Recruit Count
43
Registration Number
NCT00999713
Locations
🇺🇸

Hackensack University Medical Center, Hackensack, New Jersey, United States

🇺🇸

Maria Fareri Children's Hospital, Valhalla, New York, United States

🇺🇸

Weill Cornell Medical Center, New York, New York, United States

and more 13 locations

Calfactant for Direct Acute Respiratory Distress Syndrome

Phase 3
Terminated
Conditions
Respiratory Distress Syndrome, Adult
Interventions
Drug: Room Air (placebo)
Drug: Calfactant
First Posted Date
2008-05-22
Last Posted Date
2012-07-24
Lead Sponsor
Pneuma Pharmaceuticals Incorporated
Target Recruit Count
332
Registration Number
NCT00682500
Locations
🇨🇦

Royal Columbian Hospital, New Westminster, British Columbia, Canada

🇨🇦

Surrey Memorial Hospital, Vancouver, British Columbia, Canada

🇺🇸

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

and more 29 locations

Self-dispersing Liquids as Aerosol Drug Carriers

Not Applicable
Completed
Conditions
Cystic Fibrosis
Interventions
Drug: calfactant
Drug: isotonic saline
First Posted Date
2008-03-04
Last Posted Date
2017-08-24
Lead Sponsor
University of Pittsburgh
Target Recruit Count
8
Registration Number
NCT00628134
Locations
🇺🇸

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates

Not Applicable
Completed
Conditions
Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
First Posted Date
2005-09-21
Last Posted Date
2007-11-22
Lead Sponsor
Children's Hospital of Philadelphia
Target Recruit Count
89
Registration Number
NCT00208039
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