Authors
1 Department of Pediatrics, School of Medicine and Child Growth and Development Research Center, Isfahan, Iran
2 Department of Pediatrics, Al Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran
Abstract
Background: Surfactant administration together with nasal Continuous Positive Airway Pressure (nCPAP) administration is considered to be the basis for Newborn's Respiratory Distress Syndrome (RDS) management. This study evaluated the method of directing the surfactant to the lungs in newborns affiliated with RDS through i-gel (i-gel surfactant administration/i-gelSA) compared to the standard care INSURE method, in a clinical trial.
Materials and Methods: This randomized control trial (RCT) was done on newborns weighing ≥2000 g, with RDS, while being supported with Bubble-CPAP. Newborns, which required FiO 2 ≥0.3 under Continuous Distending Pressure (CDP) ≥5 cm H 2 O for more than 30 minutes to maintain SpO 2 in the range of 89 - 95%, were given 100 mg/kg of Survanta. In the interventional group or the i-gelSA (i-gel Surfactant Administration) group, 35 newborns experienced surfactant administration with i-gel and 35 newborns in the control or INSURE group. The average a/APO 2 before and after surfactant administration, repeated need for surfactant administration, average nCPAP duration, need for invasive mechanical ventilation, pneumothorax, and the average duration of hospitalization in the Neonatal Intensive Care Unit (NICU) were compared.
Results: Although the average a/APO 2 showed no significant difference before the procedure; in the i-gelSA group, this average was meaningfully higher after the administration of the surfactant (P = 0.001). The other factors showed no significant difference.
Conclusion: According to the results of this study, the surfactant administration using i-gel was more successful in oxygenation improvement than the INSURE method, and the i-gel method could even be promoted to the standard care position. However, more research is needed in this area.
Keywords
1. | Hamvas A. Pathophysiology and management of respiratory distress syndrome. In: Martin RJ, Fanaroff AA, Walsh MC, editors. Fanaroff and Martin's Neonatal- Perinatal Medicine. 9 th ed. St. Louis: Elsevier Mosby; 2011. p. 1106-11. |
2. | Soll RF, Morley CJ. Prophylactic versus selective use of surfsctant in preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev 2001;(2):CD000510. |
3. | Dani C, Bertini G, Pezzati M, Cecchi A, Caviglioli C, Rubaltelli FF. Early extubation and nasal continuous positive airway pressure after surfactant treatment for respiratory distress syndrome among preterm infants <30 weeks gestation. Pediaterics 2004;113:e560-3. |
4. | Booth C, Premkumar H, Yannoulis A, Thomson M, Harrison M, Edwards AD. Sustainable use of continuous positive airway pressure in extremely preterm infants during the first week after delivery. Arch Dis Child Fetal Neonatal Ed 2006;91:F398-402. |
5. | Duncan HP, Zurich NJ, Wolf AR. Should we reconsider awake neonatal intubation? Pediatr Anesth 2001;11:135-45. |
6. | Vanlooy JW, Schumacher RE, Bhatt-Mehta V. Efficacy of premedication algorithm for nonemergent intubation in a neonatal intensive care unit. Ann Pharmacother 2008;42:947-55. |
7. | Kummar P, Denson SE, Mancuso TJ. Committee on Fetus and Newborn, Section on Anesthesiology and Pain Medicine. Clinical report-premedication for nonemergency endotracheal intubation in the neonate. Pediatrics 2010;125:608-15. |
8. | Carbajal RI, Gall O, Annequin D. Pain management in neonates. Expert Rev Neurother 2004;4:491-505. |
9. | Bartman T, Becker D. Intensive care nursery house staff manual. California, United States: UCSF (University of California, San Francisco); 2004. p. 147-15. |
10. | Mhairi G, Jayashree R. Atlas of procedure in neonatology. 4 th ed. Netherlands: Wolters Kluwer; 2007. p. 251-2. |
11. | Crawford MW, Hayes J, Tan JM. Dose-response of remifentanil for tracheal intubation in infants. Anesth Analg 2005;100:1599-604. |
12. | Anand KJ. Pharamacological approaches to the management of pain in the neonatal intensive care unit. J Perinatol 2007;27:S4-11. |
13. | Perlaman JM, Mcmenamin JB. Fluctuating cerebral blood flow velocity in respiratory distress synd. Relation to the developmental of IVH. N Engl J Med 1983;309:204-9. |
14. | Stow PJ, Mcleod ME, Burrows FA, Creighton RE. Anterior fontanel pressure responses in the awake and anaesthetized infant. Br J Anaesth 1988;60:167-70. |
15. | Gizzi C, Papoff P, Barbara CS, Cangiano G, Midulla F, Moretti C. Old and new uses of surfactant. J Matern Fetal Neonatal Med 2010;23:41-4. |
16. | Archibald IJ. Brain, Laryngeal mask airway device with drug delivery means, 2010, Available from: http://www.patentstorm.us [Application 20100089393 Filed on 2007 Dec 14, published on 2010 Apr 15]. Available from: http: www.patentstorm.us/applications/20100089393/description.html [Last accessed on 2013 Jun. 15]. |
17. | Available from: http://www.i-gel.com. [Last accessed on 2013 Jun. 15]. Intersurgical Ltd., i-gel supraglottic airway, 2007, [© 2013 Intersurgical Ltd. All Rights Reserved]. Available from: http://www.intersurgical.com/products/i-gel-supraglottic-airway, http://www.i-gel.com. [Last accessed on 2013 Jun 15]. |
18. | Kribs A, Pillekamp F, Hunseler C, Vierzig A, Roth B. Early administration of surfactant in spontaneous breathing with nCPAP: Feasibility and outcome in extremely premature infants (postmenstrual age ≤27 weeks). Pediatr Anesth 2007;17:364-9. |
19. | Available from: http://www.clinicaltrials.gov. [Last accessed on 2013 Jun. 15]. Albany Medical College: Randomized controlled trial of surfactant delivery via Laryngeal Mask Airway (LMA) Versus endotracheal intubation, 2010. Available from: http://www.clinicaltrials.gov/archive/NCT01042600.[Last accessed on 2010 Jan 04, and updated on 2013 Apr 8]. |
20. | Stevens TP, Harrington EW, Blennow M, Soll RF. Early surfactant administration with brief ventilation vs selective surfactant and continued mechanical ventilation for preterm infants with or at risk for respiratory distress syndrome. Cochrane Database Syst Rev 2007;(4):CD003063. |
21. | Suresh GK, Soll RF. Pharmacologic adjunct II: Exogenous surfactants. In: Goldsmith JP, Karotkin EH, editors. Assisted ventilation of the neonate. 5 th ed. St. Louis. Missouri: Elsevire; 2011. p. 377-9. |
22. | Trevisanuto D, Grazzina N, Ferrarese P, Micaglio M, Vergehese C, Zanardo V. Laryngeal mask airway used as a delivery conduit for the administration of surfactant to preterm infants with respiratory distress syndrome. Biol Neonate 2005;87:217-20. |
23. | Rojas MA, Lozano JM, Rojas MX, Laughon M, Bose CL, Rondon MA, et al. Very early surfactant without mandatory ventilation in premature infants treated with early continuous positive airway pressure: A Randomized Controlled Trial. Pediatrics 2009;123:137-42. |
24. | Mazella M, Bellini C, Calevo MG, Campone F, Massocco D, Mezzano P, et al. A randomized control study comparing the Infant Flow Driver with nasal continuous positive airway pressure in preterm infants. Arch Dis Child Fetal Neonatal Ed 2001;85:F86-90. |
25. | Lista G, Castoldi F, Fontana P, Daniele I, Cavigioli F, Rossi S, et al. Nasal CPAP Vs Bi-level Nasal CPAP in preterms with RDS: A randomized control study. Arch Dis Child Fetal Neonatal Ed 2010;95:F85-9. |
26. | Kattwinkel J, Robinson M, Bloom BT, Delmore P, Ferguson JE. Technique for intrapartum administration of surfactant without requirement for an endotracheal tube. J Perinatol 2004;24:360-5. |
27. | Berggren E, Liljedahl M, Winbladh B, Andreasson B, Curstedt T, Robertson B, et al. Pilot study of nebulized surfactant therapy for neonatal respiratory distress syndrome. Acta Paediatr 2000;89:460-4. |
28. | Finer NN, Merritt TA, Bernstein G, Job L, Mazela J, Liu G. A multicenter pilot study of Aerosurf delivered via nasal continuous positive airway pressure to prevent respiratory distress syndrome in preterm neonates. Pediatr Res 2006;59:40-8. |
29. | Zhang JP, Wang YL, Wang YH, Zhang R, Chen H, Su HB. Prophylaxis of neonatal respiratory distress syndrome by intra-amniotic administration of pulmonary surfactant. Chin Med J (Engl) 2004;117:120-4. |
30. | Brimacombe J, Gandini D, Keller C. The laryngeal mask airway for administration of surfactant in two neonates with respiratory distress syndrome. Pediatr Anesth 2004;14:188-90. |