A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023698%3A_____%2F22%3AN0000004" target="_blank" >RIV/00023698:_____/22:N0000004 - isvavai.cz</a>
Alternative codes found
RIV/00064165:_____/22:10445200
Result on the web
<a href="https://www.sciencedirect.com/science/article/pii/S0022347622001755" target="_blank" >https://www.sciencedirect.com/science/article/pii/S0022347622001755</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.jpeds.2022.02.054" target="_blank" >10.1016/j.jpeds.2022.02.054</a>
Alternative languages
Result language
angličtina
Original language name
A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome
Original language description
Objective To investigate the efficacy and safety of nebulized poractant alfa (at 200 and 400 mg/kg doses) delivered in combination with nasal continuous positive airway pressure compared with nasal continuous positive airway pressure alone in premature infants with diagnosed respiratory distress syndrome. Study design This randomized, controlled, multinational study was conducted in infants at 28(0/7) to 32(6/7) weeks of gestation. The primary outcome was the incidence of respiratory failure in the first 72 hours of life, defined as needing endotracheal surfactant and/or mechanical ventilation owing to prespecified criteria. Secondary outcomes included the time to respiratory failure in the first 72 hours, duration of ventilation, mortality, incidence of broncho-pulmonary dysplasia, and major associated neonatal comorbidities. In addition, the safety and tolerability of the treatments were assessed reporting the number and percentage of infants with treatment-emergent adverse events and adverse drug reactions during nebulization.Results In total, 129 infants were randomized. No significant differences were observed for the primary outcome: 24 (57%), 20 (49%), and 25 (58%) infants received endotracheal surfactant and/or mechanical ventilation within 72 hours in the poractant alfa 200 mg/kg, poractant alfa 400 mg/kg, and nasal continuous positive airway pressure groups, respectively. Similarly, secondary respiratory outcomes did not differ among groups. Enrollment was halted early owing to a change in the benefit-risk balance of the intervention. Nebulized poractant alfa was well-tolerated and safe, and no serious adverse events were related to the study treatment. Conclusions The intervention did not decrease the likelihood of respiratory failure within the first 72 hours of life.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30209 - Paediatrics
Result continuities
Project
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2022
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
JOURNAL OF PEDIATRICS
ISSN
0022-3476
e-ISSN
1097-6833
Volume of the periodical
240
Issue of the periodical within the volume
Jul 2022
Country of publishing house
US - UNITED STATES
Number of pages
8
Pages from-to
40-47.e5
UT code for WoS article
000814869400008
EID of the result in the Scopus database
2-s2.0-85127329629