Clinical Studies

For those of you interested in learning more about Survanta and surfactant, here is a list of clinical studies that provide additional information.
 

Survanta Studies

Hoekstra RE, Jackson JC, Myers TF, et al: Improved neonatal survival following multiple doses of bovine surfactant in very premature neonates at risk for respiratory distress syndrome. Pediatrics 1991;88:10-18.

Horbar JD, Soll RF, Schachinger H, et al: A European multicenter randomized controlled trial of single dose surfactant therapy for idiopathic respiratory distress syndrome. Eur J Pediatr 1990;149:416-423.

Liechty EA, Donovan E, Purohit D, et al: Reduction of neonatal mortality after multiple doses of bovine surfactant in low birth weight neonates with respiratory distress syndrome. Pediatrics 1991;88:19-28.

Soll RF, Hoekstra RE, Fangman JJ, et al: Multicenter trial of single-dose modified bovine surfactant extract (Survanta) for prevention of respiratory distress syndrome. Pediatrics 1990;85:1092-1102.

Survanta Multidose Study Group: Two-year follow-up of infants treated for neonatal respiratory distress syndrome with bovine surfactant. J Pediatr 1994;124:962-967.

Whitsett JA, Hull WM, Luse S: Failure to detect surfactant protein-specific antibodies in sera of premature infants treated with Survanta, a modified bovine surfactant. Pediatrics 1991;87:505-510.

Zola EM, Gunkel JH, Chan RK, et al: Comparison of three dosing procedures for administration of bovine surfactant to neonates with respiratory distress syndrome. J Pediatr 1993;122:453-459.

Zola EM, Overbach AM, Gunkel JH, et al: Treatment investigational new drug experience with Survanta (beractant). Pediatrics 1993;91:546-551.

Important Safety Information about Survanta? (beractant)

SURVANTA is intended for intratracheal use only.

SURVANTA CAN RAPIDLY AFFECT OXYGENATION AND LUNG COMPLIANCE. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide.

DURING THE DOSING PROCEDURE, TRANSIENT EPISODES OF BRADYCARDIA AND DECREASED OXYGEN SATURATION HAVE BEEN REPORTED. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure.