Randomised Clinical Trial of Two Treatment Regimens of Natural Surfactant Preparations in Neonatal Respiratory Distress Syndrome

Overview

Journal Arch Dis Child Fetal Neonatal Ed

Specialties Gynecology & Obstetrics
Pediatrics

Date 1995 Jan 1

PMID 7743295

Citations 38

Authors

C P Speer

O Gefeller

P Groneck

E Laufkotter

C Roll

L Hanssler

K Harms

E Herting

H Boenisch

J Windeler

Affiliations

Soon will be listed here.

Abstract

Aims: To compare treatment regimens of two widely used natural surfactant preparations Curosurf and Survanta in respiratory distress syndrome (RDS).

Methods: The effects of the two treatment regimens on gas exchange, ventilatory requirements, and 28 day outcome in infants with RDS were compared. Seventy five preterm infants (birth weight 700-1500 g) with RDS requiring artificial ventilation with an FIO2 of > or = 0.4, were randomly selected at 1-24 hours of age. One group received an initial dose of Curosurf (200 mg/kg); the other group Survanta (100 mg/kg). Patients who remained dependent on artificial ventilation with an FIO2 of > or = 0.3 received up to two additional doses of Curosurf (each of 100 mg/kg) after 12 and 24 hours or up to three additional doses of Survanta (each of 100 mg/kg) between six and 48 hours after the initial dose.

Results: There was a rapid improvement in oxygenation and ventilatory requirements were reduced in both groups. However, infants treated with Curosurf had a higher arterial:alveolar oxygen tension ratio and required a lower peak inspiratory pressure and mean airway pressure at several time points within 24 hours of randomisation (p < 0.05-0.001). The incidences of pneumothorax in the Curosurf and Survanta groups were 6% and 12.5%, respectively; the corresponding figures for grades 3-4 intracerebral haemorrhage were 3% and 12.5%, respectively. Mortality was 3% in the Curosurf group and 12.5% in the Survanta group. However, these differences did not reach significance.

Conclusion: The Curosurf treatment regimen resulted in a more rapid improvement in oxygenation than Survanta and reduced ventilatory requirements up to 24 hours after start of treatment. This was associated with a trend towards reduced incidence of serious pulmonary and non-pulmonary complications.

Citing Articles

Comparative efficacy of pulmonary surfactant in respiratory distress syndrome in preterm infants: a Bayesian network meta-analysis.

Qiu C, Ma C, Fan N, Zhang X, Zheng G Arch Med Sci. 2023; 19(5):1446-1453.

PMID: 37732036 PMC: 10507746. DOI: 10.5114/aoms.2020.97065.

Comparing the clinical and economic efficiency of four natural surfactants in treating infants with respiratory distress syndrome.

Izadi R, Shojaei P, Haqbin A, Habibolahi A, Sadeghi-Moghaddam P PLoS One. 2023; 18(6):e0286997.

PMID: 37390082 PMC: 10313081. DOI: 10.1371/journal.pone.0286997.

Surfactant Stock Optimization for Cost Minimization in Neonatal Intensive Care Units.

Narli M, Kokangul A J Healthc Eng. 2021; 2021:8346584.

PMID: 34900205 PMC: 8654546. DOI: 10.1155/2021/8346584.

Nanomedicine for acute respiratory distress syndrome: The latest application, targeting strategy, and rational design.

Qiao Q, Liu X, Yang T, Cui K, Kong L, Yang C Acta Pharm Sin B. 2021; 11(10):3060-3091.

PMID: 33977080 PMC: 8102084. DOI: 10.1016/j.apsb.2021.04.023.

Bilayer aggregate microstructure determines viscoelasticity of lung surfactant suspensions.

Ciutara C, Zasadzinski J Soft Matter. 2021; 17(20):5170-5182.

PMID: 33929473 PMC: 8194287. DOI: 10.1039/d1sm00337b.

References

Jobe A . Pulmonary surfactant therapy. N Engl J Med. 1993; 328(12):861-8. DOI: 10.1056/NEJM199303253281208. View

NEWELL D . Intention-to-treat analysis: implications for quantitative and qualitative research. Int J Epidemiol. 1992; 21(5):837-41. DOI: 10.1093/ije/21.5.837. View

Halliday H, Tarnow-Mordi W, Corcoran J, Patterson C . Multicentre randomised trial comparing high and low dose surfactant regimens for the treatment of respiratory distress syndrome (the Curosurf 4 trial). Arch Dis Child. 1993; 69(3 Spec No):276-80. PMC: 1029491. DOI: 10.1136/adc.69.3_spec_no.276. View

Horbar J, Wright L, Soll R, Wright E, Fanaroff A, KORONES S . A multicenter randomized trial comparing two surfactants for the treatment of neonatal respiratory distress syndrome. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1993; 123(5):757-66. DOI: 10.1016/s0022-3476(05)80856-x. View

Egberts J, de Winter J, Sedin G, De Kleine M, Broberger U, van Bel F . Comparison of prophylaxis and rescue treatment with Curosurf in neonates less than 30 weeks' gestation: a randomized trial. Pediatrics. 1993; 92(6):768-74. View

Speer C, Ruess D, Harms K, Herting E, Gefeller O . Neutrophil elastase and acute pulmonary damage in neonates with severe respiratory distress syndrome. Pediatrics. 1993; 91(4):794-9. View

Papile L, BURSTEIN J, Burstein R, KOFFLER H . Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978; 92(4):529-34. DOI: 10.1016/s0022-3476(78)80282-0. View

Nohara K, Berggren P, Curstedt T, Grossmann G, Nilsson R, Robertson B . Correlations between physical and physiological properties of various preparations of lung surfactant. Eur J Respir Dis. 1986; 69(5):321-35. View

Fawer C, Diebold P, Calame A . Periventricular leucomalacia and neurodevelopmental outcome in preterm infants. Arch Dis Child. 1987; 62(1):30-6. PMC: 1778161. DOI: 10.1136/adc.62.1.30. View

10.

Speer C, Rethwilm M, Gahr M . Elastase-alpha 1-proteinase inhibitor: an early indicator of septicemia and bacterial meningitis in children. J Pediatr. 1987; 111(5):667-71. DOI: 10.1016/s0022-3476(87)80240-8. View

11.

Horbar J, Soll R, Sutherland J, Kotagal U, Philip A, KESSLER D . A multicenter randomized, placebo-controlled trial of surfactant therapy for respiratory distress syndrome. N Engl J Med. 1989; 320(15):959-65. DOI: 10.1056/NEJM198904133201502. View

12.

Soll R, Hoekstra R, Fangman J, Corbet A, Adams J, James L . Multicenter trial of single-dose modified bovine surfactant extract (Survanta) for prevention of respiratory distress syndrome. Ross Collaborative Surfactant Prevention Study Group. Pediatrics. 1990; 85(6):1092-102. View

13.

Hoekstra R, Jackson J, Myers T, Frantz 3rd I, Stern M, Powers W . Improved neonatal survival following multiple doses of bovine surfactant in very premature neonates at risk for respiratory distress syndrome. Pediatrics. 1991; 88(1):10-8. View

14.

Liechty E, Donovan E, Purohit D, Gilhooly J, Feldman B, Noguchi A . Reduction of neonatal mortality after multiple doses of bovine surfactant in low birth weight neonates with respiratory distress syndrome. Pediatrics. 1991; 88(1):19-28. View

15.

Speer C, Robertson B, Curstedt T, Halliday H, Compagnone D, Gefeller O . Randomized European multicenter trial of surfactant replacement therapy for severe neonatal respiratory distress syndrome: single versus multiple doses of Curosurf. Pediatrics. 1992; 89(1):13-20. View

16.

Hellstrom-Westas L, Bell A, Skov L, Greisen G, SVENNINGSEN N . Cerebroelectrical depression following surfactant treatment in preterm neonates. Pediatrics. 1992; 89(4 Pt 1):643-7. View

17.

Skov L, Hellstrom-Westas L, Jacobsen T, Greisen G, SVENNINGSEN N . Acute changes in cerebral oxygenation and cerebral blood volume in preterm infants during surfactant treatment. Neuropediatrics. 1992; 23(3):126-30. DOI: 10.1055/s-2008-1071327. View