Pediatr Int. 2026 Jan-Dec;68(1):e70385. doi: 10.1111/ped.70385.
ABSTRACT
BACKGROUND: Although sildenafil is commonly used for bronchopulmonary dysplasia-associated pulmonary hypertension (BPD-PH), high-quality evidence to justify its use remains sparse. Thus, we evaluated the efficacy and safety of sildenafil in preterm infants with BPD or BPD-PH.
METHODS: A systematic review of randomized and non-randomized comparative studies identified by searching MEDLINE, Embase, Cochrane Central Register of Controlled trials, Cumulative Index to Nursing and Allied Health Literature, and Ichushi-Web until November 28, 2024. The primary outcome measure was mortality at the time of neonatal intensive care unit (NICU) discharge.
RESULTS: Among the 1944 studies identified, 54 were eligible for full-text screening; however, none met the systematic review criteria. A post hoc narrative synthesis summarized the outcomes of preterm BPD-PH infants receiving sildenafil in nine studies, which were ineligible for the systematic review due to the lack of control groups. These studies included 15-666 infants born in high-income countries from 2001 to 2022. Sildenafil treatment improved the PH symptoms in 47%-77% of patients according to the echocardiographic findings. In patients receiving sildenafil, mortality before NICU discharge was 13%-35% and the rate of severe retinopathy of prematurity was 16%-57%.
CONCLUSIONS: Evidence to support the use of sildenafil treatment for preterm infants with BPD-PH to improve mortality and morbidity is lacking. More research, particularly randomized controlled trials, on the efficacy and safety of sildenafil treatment for preterm BPD-PH infants is needed.
PMID:41943894 | DOI:10.1111/ped.70385
