High vs low CPAP strategy with aerosolized calfactant in preterm infants with respiratory distress syndrome. Optimal CPAP strategy to prevent CPAP failure defined as need for endotracheal intubation is unknown. To evaluate the risk of CPAP failure in infants treated with high vs low CPAP strategy while receiving aerosolized calfactant in the AERO-02 clinical trial and AERO-03 expanded access received aerosolized calfactant that were treated with high vs low CPAP strategy. Efficacy of high CPAP strategy with aerosolized surfactant treatment needs to be evaluated in future studies.
Response to aerosolized calfactant in infants with respiratory distress syndrome; a post-hoc analysis of AERO-02 trial. The aerosolized calfactant decreased the need for intubation in neonates with respiratory distress syndrome (AERO-02 trial). To determine the oxygenation response to aerosolized calfactant among infants born 28 0/7-36 6/7 weeks with RDS in the AERO-02 trial. Trends in hourly fraction of oxygen (FiO), mean airway pressure (MAP) and respiratory severity score (RSS) were compared between the aerosolized calfactant (AC) and usual care (UC) groups from time of randomization for 72 h. A total of 353 subjects were included in the study. FiO, MAP, and RSS were lower in the UC group. FiO decrease was seen after the first aerosolized calfactant dose. FiO, MAP, and RSS were lower
Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial Exogenous surfactants to treat respiratory distress syndrome (RDS) are approved for tracheal instillation only; this requires intubation, often followed by positive pressure ventilation to promote distribution. Aerosol delivery offers a safer alternative, but clinical studies have had mixed results. We hypothesized that efficient aerosolization of a surfactant with low viscosity, early in the course of RDS, could reduce the need for intubation and instillation of liquid surfactant. A prospective, multicenter, randomized, unblinded comparison trial of aerosolized calfactant (Infasurf) in newborns with signs of RDS that required noninvasive respiratory support. Calfactant was aerosolized by using a Solarys nebulizer
CALIPSO: A Randomized Controlled Trial of Calfactant for Acute Lung Injury in Pediatric Stem Cell and Oncology Patients. To assess if calfactant reduces mortality among children with leukemia/lymphoma or after hematopoietic cell transplantation (HCT) with pediatric acute respiratory distress syndrome (PARDS), we conducted a multicenter, randomized, placebo-controlled, double-blinded trial in 17 pediatric intensive care units (PICUs) of tertiary care children's hospitals. Patients ages 18 months to 25 years with leukemia/lymphoma or having undergone HCT who required invasive mechanical ventilation for bilateral lung disease with an oxygenation index (OI) > 10 and <37 were studied. Interventions used were intratracheal instillation of either calfactant or air placebo (1 or 2 doses). Forty-three
The Adult Calfactant in Acute Respiratory Distress Syndrome Trial. Surfactant has been shown to be dysfunctional in ARDS, and exogenous surfactant has proven effective in many forms of neonatal and pediatric acute lung injury (ALI). In view of the positive results of our studies in children along with evidence that surfactant-associated protein B containing pharmaceutical surfactants might be more effective, we designed a multiinstitutional, randomized, controlled, and masked trial of calfactant, a calf lung surfactant, in adults and children with ALI/ARDS due to direct lung injury. Adult subjects within 48 h of initiation of mechanical ventilation for direct ARDS were randomized to receive up to three interventions with instilled calfactant vs air placebo. The primary outcome was 90-day
Pediatric Calfactant in Acute Respiratory Distress Syndrome Trial. Our previous studies in children with acute lung injury/acute respiratory distress syndrome demonstrated improved outcomes with exogenous surfactant (calfactant) administration. Sample sizes in those studies were small, however, and the subject populations heterogeneous, thus making recommendations tenuous. To investigate randomized to receive up to three doses of 30 mg/cm height of surfactant (calfactant) versus placebo (air) within 48 hours of intubation and initiation of mechanical ventilation. The primary outcome was mortality at 90 days. Ventilator-free days, changes in oxygenation, and adverse events were also assessed. The study was stopped at the sponsor's request after the second interim analysis for presumed
The Relationship of Fluid Administration to Outcome in the Pediatric Calfactant in Acute Respiratory Distress Syndrome Trial. Adult studies have demonstrated the relationship between fluid overload and poor outcomes in acute lung injury/acute respiratory distress syndrome. The approach of pediatric intensivists to fluid management in acute lung injury/acute respiratory distress syndrome and its effect on outcomes is less clear. In a post hoc analysis of our Calfactant in Acute Respiratory Distress Syndrome trial, we examined the relationship of fluid balance to in-hospital outcomes in subjects with acute lung injury/acute respiratory distress syndrome. Calfactant in Acute Respiratory Distress Syndrome was a masked randomized controlled trial of calfactant surfactant versus placebo
The Ministry of Health’s Drug Advisory Committee has recommended: * Calfactant 105 mg/3 ml and 210 mg/6 ml and poractant alfa 120 mg/1.5 ml intratracheal suspension vials for treating respiratory distress syndrome in premature infants ..
was carried out in the animal laboratory of Kahramanmaraş Sütçü İmam University between March 1 and March 31, 2020. An experimental intra-abdominal adhesion model was established in 24 adult female rats by cecal abrasion. Rats were randomly divided into four groups. Groups I, II, and III were taken intraperitoneally as beractant, poractant, and calfactant applied groups, respectively. Group IV
Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study A pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with RDS. Surfactant therapy can be life-saving for newborn infants with respiratory distress due to surfactant
unit (NICU) of Busan Paik Hospital between January 2018 and December 2018 and diagnosed with severe RDS were enrolled. The treatment group was given a mixture of budesonide and surfactant (calfactant) while the control group was given surfactant (calfactant) only. Surfactant re-dosing, duration of mechanical ventilation, BPD, mortality, and retinopathy of prematurity (≥ stage 2) were not different
, Hibberd PL, Fineman LD, et al. Effect of prone positioning on clinical outcomes in children with acute lung injury: a randomized controlled trial. JAMA. 2005 Jul 13. 294(2):229-37. [QxMD MEDLINE Link]. 13. Willson DF, Thomas NJ, Markovitz BP, et al. Effect of exogenous surfactant (calfactant) in pediatric acute lung injury: a randomized controlled trial. JAMA. 2005 Jan 26. 293(4):470-6. [QxMD
fractional inspired oxygen (FiO) need, arterial PaO values, Downes and LUS scores were noted. The patients were randomized into three groups; Group 1 ( = 23), poractant alpha; Group 2 ( = 20), beractant; and Group 3 ( = 19), calfactant. The groups were compared according to clinical, laboratory and radiological variables as well as LUS scores. Gestational age ( = .05), birthweight ( = .07), and SNAPPE-II ). The durations of total oxygen supplementation, mechanical ventilation, and hospital stay were the same in groups ( > .05). In newborns with RDS, poractant alpha and beractant have similarly reduced oxygen need in accordance to the LUS findings. However, they seem to be superior compared to calfactant.
groups of healthy cycling women were randomized to receive vaginally a single dose of the following: (1) low-dose calfactant, a type of surfactant lipids, 0.8 mg/ml; (2) high-dose calfactant 8.0 mg/ml; or (3) placebo, at the time of resolution of menses. Vaginal mucosal fluid was collected before administration and also 1 and 8 days after administration of each treatment. After 1 mo, each group was randomized to each alternative treatment; thus, for a 3-month treatment period, each group received each of the 3 treatments. Vaginal fluid was tested using a Multiplex Immunoassay System. Cytokine concentrations on day 1 and day 8 were compared with day zero and tested for significance with the Student's t test. Six healthy subjects completed each treatment. Subjects given high-dose calfactant had, by day
(beractant, calfactant, and poractant alfa) is sur-SURFACTANTREPLACEMENTTHERAPY: 2013370RESPIRATORYCARE•FEBRUARY2013 VOL58 NO2factant protein B (SP-B). SP-B has been found toreduce surface tension to a greater extent than surfac-tant protein-C (SP-C). Congenital absence of SP-B atbirth is lethal, while SP-C deficiency is not associatedwith respiratory failure.78Older generation syntheticsurfactant
to augment cholesterol efflux from endothelial cells to the plasma lipoprotein HDL. Here, we find that AIBP was expressed in inflammatory cells in the human lung and was secreted into the bronchoalveolar space in mice subjected to inhalation of LPS. AIBP bound surfactant protein B and increased cholesterol efflux from alveolar macrophages to calfactant, a therapeutic surfactant formulation. In vitro, AIBP
Surfactant Administration in Preterm Infants: Drug Development Opportunities. To evaluate how frequently surfactant is used off-label in preterm infants. We conducted a retrospective cohort analysis of prospectively collected administrative data for 2005-2015 from 348 neonatal intensive care units in the US. We quantified off-label administration of poractant alfa, calfactant, or beractant (40 716 [37%]), had an older GA than those who received surfactant on-label (35 191 [32%]), or were treated with intubation and surfactant administration followed by immediate extubation (INSURE) (32 310 [29%]). Poractant alfa was administered via INSURE more frequently than beractant or calfactant (16 688 [38%], 7137 [20%], and 8485 [27%], respectively). An increasing number of infants received
behavior of lung surfactant at the air-liquid interface of mucus-like viscoelastic gels. Poly(acrylic acid) hydrogels were formulated to serve as a model mucus with bulk rheological properties that matched those of tracheobronchial mucus secretions. Infasurf (Calfactant), a commercially available pulmonary surfactant derived from calf lung extract, was spread onto the hydrogel surface. The surface