A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome
Abstract
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 (nCPAP) compared with nCPAP alone in premature babies with diagnosed RDS.
STUDY DESIGN
This randomized, controlled, multinational study was conducted in 28+0 to 32+6 weeks gestation infants. 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 due to prespecified criteria. Secondary outcomes included the time to respiratory failure in the first 72 hours, duration of ventilation, mortality, incidence of bronchopulmonary dysplasia, and major associated neonatal comorbidities. In addition, the safety and tolerability of the treatments were assessed reporting the number and percentage of babies with treatment-emergent adverse events and adverse drug reactions during nebulization.
RESULTS
129 babies 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 nCPAP groups, respectively. Similarly, secondary respiratory outcomes did not differ among groups. Enrollment was halted early due to a change in the benefit-risk balance of the intervention. Nebulized Poractant alfa was well tolerated and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 6 participants or records.
Read the paper
Related studies
- Safety and efficacy of COVID‐19 vaccines: A systematic review and meta‐analysis of controlled and randomized clinical trials
- Accuracy Comparison between Robot-Assisted Dental Implant Placement and Static/Dynamic Computer-Assisted Implant Surgery: A Systematic Review and Meta-Analysis of In Vitro Studies
- Determinants of passive antibody efficacy in SARS-CoV-2 infection: a systematic review and meta-analysis
- Cleaning efficacy of EDDY versus ultrasonically-activated irrigation in root canals: a systematic review and meta-analysis
- Bonding Efficacy of Universal Resin Adhesives to Zirconia Substrates: Systematic Review and Meta-Analysis
- In vitro antimicrobial activity of extracts and essential oils of Cinnamomum, Salvia, and Mentha spp. against foodborne pathogens: A meta-analysis study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.