A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00064165:_____/22:10445200

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30209 - Paediatrics

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

JOURNAL OF PEDIATRICS

ISSN

0022-3476

e-ISSN

1097-6833

Svazek periodika

240

Číslo periodika v rámci svazku

Jul 2022

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

8

Strana od-do

40-47.e5

Kód UT WoS článku

000814869400008

EID výsledku v databázi Scopus

2-s2.0-85127329629