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Open Access 01-12-2016 | Research

Effectiveness of intratracheal salbutamol in addition to surfactant on the clinical course of newborns with respiratory distress syndrome: a clinical trial

Authors: Masoud Dehdashtian, Arash Malakian, Mohammad Reza Aramesh, Ali Mazori, Mohammad Hasan Aletayeb, Afsaneh Shirani, Shiva Bashirnejad

Published in: Italian Journal of Pediatrics | Issue 1/2016

Abstract

Background

In addition to surfactant deficiency, increase of lung fluid content and secretion of fluid derived from the blood participate in the pathogenesis of RDS in newborns.

We hypothesized that the administration of salbutamol (β-agonist) to increase lung fluid absorption would decrease the INSURE failure rate in newborns with respiratory distress syndrome (RDS) treated with intratracheal surfactant.

Methods

Design

Blinded, randomized clinical trial study.

Setting/population

Level III NICU, premature infants with RDS requiring intratracheal Surfactant.

Forty Eight newborns with RDS treated with intratracheal Surfactant were randomized into two groups as Group A, Normal saline (as control group) and Group B (intervention group), Salbutamol were administered intratracheally in addition to Surfactant. Intubation-Surfactant administration- Rapid Extubation (INSURE) failure rate as primary outcome and secondary outcome as follow: duration of the need to NCPAP, mechanical ventilation and oxygen therapy; complications (patent ductus arteriosus, pneumothorax); mortality (respiratory or prematurity related complication) and the duration of hospitalization were assessed.

Results

Twenty Four patients in each group were studied. INSURE failure was seen in16 (66.7 %) and 10 (41.7 %) of normal saline and salbutamol groups respectively (p = 0.082). The duration of NCPAP in control group was 69.5 ± 54.9 h while in Salbutamol group was 51.6 ± 48.7 h (p = 0.316). All of deaths were related to respiratory failure. No differences in mortality or complications of RDS were observed. The duration of hospitalization was longer in control group than interventional group, 28.3 ± 18.1 and 18.6 ± 8.6 days, respectively. (p = 0.047).

Conclusion

Salbutamol may improve the clinical course of newborns with RDS requiring Surfactant.

Trial registration number

IRCT2014072714215N1

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Title: Effectiveness of intratracheal salbutamol in addition to surfactant on the clinical course of newborns with respiratory distress syndrome: a clinical trial
Authors: Masoud Dehdashtian
Arash Malakian
Mohammad Reza Aramesh
Ali Mazori
Mohammad Hasan Aletayeb
Afsaneh Shirani
Shiva Bashirnejad
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Italian Journal of Pediatrics / Issue 1/2016
Electronic ISSN: 1824-7288
DOI: https://doi.org/10.1186/s13052-016-0215-1

At a glance: The STEP trials

Springer Medicine

Effectiveness of intratracheal salbutamol in addition to surfactant on the clinical course of newborns with respiratory distress syndrome: a clinical trial

Abstract

Background

Methods

Results

Conclusion

Trial registration number

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

Trial registration number

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