Prophylactic sildenafil in preterm infants at risk of bronchopulmonary
dysplasia: A systematic review and meta-analysis
Abstract
Objective: This study aimed to investigate the efficacy and
safety of prophylactically administered sildenafil during the early life
stages of preterm infants to prevent mortality and bronchopulmonary
dysplasia (BPD). Data Sources: MEDLINE, Embase, Cochrane
Central Register of Controlled Trials, Cumulative Index to Nursing and
Allied Health Literature, and Ichushi. Study Selection:
Published randomized controlled trials (RCTs), non‐RCTs, interrupted
time series, cohort studies, case–control studies, and controlled
before‐and-after studies were included. Data Extraction: Two
reviewers independently screened the title, abstract, and full text,
extracted data, assessed the risk of bias, and evaluated the certainty
of evidence (CoE) following the Grading of Recommendations Assessment
and Development and Evaluation approach. The random‐effects model was
used for a meta‐analysis of RCTs. Results: This review included
three RCTs (162 infants). The prophylactic sildenafil and placebo groups
demonstrated no significant differences in mortality (risk ratio
[RR]: 1.32; 95% confidence interval [CI]: 0.16–10.76; very low
CoE) and BPD (RR: 1.20; 95% CI: 0.79–1.83; very low CoE), as well as
in any other outcome assessed (very low CoE). Limitations: The
sample sizes were less than the optimal sizes for all outcomes assessed,
indicating the need for further trials. Conclusions: The
prophylactic use of sildenafil in individuals at risk of BPD did not
indicate any advantageous effects in terms of mortality, BPD, and other
outcomes, or increased side effects.