NEODOSE

INDICATIONS

• Respiratory distress syndrome (RDS): Routine continuous positive airway pressure (CPAP) is considered superior to prophylactic surfactant therapy. It is strongly recommended that CPAP immediately after birth with subsequent selective surfactant administration be considered as an alternative to routine intubation with prophylactic or early surfactant administration in preterm infants. Severe RDS in preterm infants born younger than 30 weeks gestation who need mechanical ventilation should be administered surfactant after initial stabilization. Consider the use of rescue surfactant for infants with hypoxic respiratory failure attributable to secondary surfactant deficiency, such as meconium aspiration syndrome or sepsis/pneumonia. Animal-derived surfactants (beractant, calfactant, and poractant alfa) had comparable outcomes for air leak syndromes, death, and bronchopulmonary dysplasia in a retrospective study (n=51,282; median birth weight of 1435 g; median gestation age of 30 weeks (27 to 33 weeks)).
• Late Administration: Calfactant administered at 7 to 14 days of age in infants (28 weeks of gestational age or younger) who required mechanical ventilation and were receiving inhaled nitric oxide did not improve survival without bronchopulmonary dysplasia (BPD) at 36 weeks’ or 40 weeks’ postmenstrual age or improve the severity of BPD, in a randomized, masked, multicenter trial (n=511). Infants were randomized to either calfactant every 24 to 72 hours up to 5 doses, if the infants still required intubation, or sham. Due to unlikely benefit the trial was terminated early . At 1-year corrected age follow-up (n=450), home respiratory support was reduced with late surfactant compared with inhaled nitric oxide alone. However, no improvement was noted on composite outcome of pulmonary morbidity (PM) (measured by use of medications, hospitalization, and home respiratory support) or persistent PM.

FDA APPROVED INDICATION

Infasurf® is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants less than 29 weeks of gestational age at significant risk for RDS. Treatment should be given as soon as possible, preferably within 30 minutes after birth. Infasurf® is indicated for infants less than 72 hours of age with RDS (confirmed by clinical and radiological findings) and requiring endotracheal intubation.

PRECAUTIONS

Transient episodes of reflux of surfactant into the endotracheal tube, cyanosis, bradycardia, and airway obstruction have been reported during administration. A higher rate of intraventricular hemorrhage and periventricular leukomalacia was observed in Infasurf®- treated infants compared with Exosurf®-treated infants in clinical trials.

ADVERSE EFFECTS

Most common adverse reactions observed in clinical trials were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%). Reactions were usually transient and not associated with severe complications or mortality.

ADMINISTRATION

For intratracheal administration only

Warming of suspension is not necessary Calfactant intratracheal suspension may be administered by either of the following 2 methods

• 1) Administration by instilling the suspension through a side-port adapter into the endotracheal tube. Two attendants are needed to facilitate dosing; one to instill the calfactant, the other to monitor the patient and assist in positioning. The dose (3 mL/kg) should be administered in 2 aliquots of 1.5 mL/kg each. After each aliquot is instilled, the neonate should be positioned with either the right or the left side dependent. Administration is made while ventilation is continued over 20 to 30 breaths for each aliquot, with small bursts timed only during the inspiratory cycles. A pause followed by evaluation of the respiratory status and repositioning should separate the two aliquots.
• 2) Administration by instilling the suspension through a 5 French feeding tube inserted into the endotracheal tube. The total dose is instilled in 4 equal aliquots with the catheter removed between each instillation and mechanical ventilation resumed for 0.5 to 2 minutes. For even distribution of calfactant, each of the aliquots should be administered with the neonate in 1 of 4 positions; prone, supine, right, and left lateral.

MONITORING

Monitor closely for appropriate oxygen therapy and ventilatory support.