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The effect of sildenafil on evolving bronchopulmonary dysplasia in extremely preterm infants: a randomised controlled
Kai König1, Charles P Barfield, Katelyn J Guy
1Mercy Hospital for Women, Department of Paediatrics , Melbourne, Victoria , Australia and.
Insights
Oral sildenafil did not improve respiratory outcomes in extremely preterm infants with bronchopulmonary dysplasia. This pilot study found no benefits and noted potential side effects, indicating further research is needed for this vulnerable population.
Area of Science:
- Neonatal Medicine
- Pediatric Pulmonology
- Pharmacology
Background:
- Bronchopulmonary dysplasia (BPD) is a chronic lung disease affecting preterm infants.
- Sildenafil has shown promise in animal models for preserving lung development.
- Feasibility of sildenafil for BPD in extremely preterm infants is unexplored.
Purpose of the Study:
- To assess the feasibility of oral sildenafil treatment in extremely preterm infants with evolving bronchopulmonary dysplasia.
- To evaluate short-term cardiorespiratory outcomes and side effects of sildenafil in this population.
Main Methods:
- A proof-of-concept randomized controlled pilot study.
- Inclusion criteria: preterm infants <28 weeks gestational age, mechanically ventilated on day 7.
- Intervention: 4-week course of oral sildenafil (3 mg/kg/day) or placebo.
Main Results:
- Twenty infants were randomized; 10 received sildenafil, 10 received placebo.
- Sildenafil did not reduce the duration of invasive or non-invasive ventilation.
- Increased need for postnatal steroids and one case of hypotension were observed in the sildenafil group.
Conclusions:
- Oral sildenafil treatment did not improve short-term respiratory outcomes in extremely preterm infants.
- The study suggests sildenafil is not beneficial for BPD in this population and may have associated risks.
- Further investigation into sildenafil's role in neonatal lung disease is warranted.
Objective:
Sildenafil has been shown to preserve alveolar growth and lung angiogenesis in a rat model of bronchopulmonary dysplasia. We conducted a proof-of-concept randomised controlled pilot study to assess the feasibility of oral sildenafil treatment in extremely preterm infants with evolving bronchopulmonary dysplasia.
Methods:
Preterm infants <28 weeks gestational age were eligible if they were mechanically ventilated on day 7 of life. Infants were randomised to a 4-weeks course of either oral sildenafil (3 mg/kg/day) or placebo solution. Pre-discharge cardiorespiratory outcomes and medication side effects were collected.
Results:
Twenty infants were randomised, 10 received sildenafil (mean gestational age 24 + 5 weeks (SD 4.9 days), mean weight 692 g (SD 98)) and 10 received placebo (mean gestational age 24 + 5 weeks (SD 6.5 days), mean weight 668 g (SD 147)). One infant in the sildenafil group did not receive treatment because of an early pneumoperitoneum. Two infants did not complete the study (transferred out). Of the remaining seven treated infants, three died (two from respiratory-related causes). One infant in the control group died from a non-respiratory cause. Sildenafil did not reduce length of invasive (median 688 versus 227 h) or non-invasive ventilation (median 1609 versus 1416 h). More infants in the sildenafil group required postnatal steroid treatment. One infant developed hypotension following sildenafil administration and was excluded after three doses.
Conclusions:
In this pilot study, oral sildenafil treatment did not improve any short-term respiratory outcomes in extremely preterm infants.
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