Outcome of oral sildenafil in neonatal persistent pulmonary hypertension of non-cardiac causes.
BACKGROUND
Despite recent treatment modalities, mortality from persistent pulmonary hypertension (PPHN) remains significant. In instances where infants do not respond to inhaled nitric oxide (iNO), oral sildenafil could hold promise as a selective pulmonary vasodilator. Further studies are still needed to explore its efficacy and safety in newborns with PPHN.


OBJECTIVE
To validate the efficacy of oral sildenafil on oxygenation and its short-term safety in newborns with persistent pulmonary hypertension.


METHODS
A total of 27 newborns ≥36 weeks gestational age were admitted to NICU with oxygenation index (OI) ≥15 and confirmed diagnosis of PPHN with echocardiography. Oral sildenafil given at a dose of 1-2 mg/kg every 6 hours. We monitored improvement in oxygenation, safety and short-term outcomes.


RESULTS
Among 27 newborns, oral sildenafil was efficacious in 21 patients (78%) with reduction of OI from 34.9 ± 9.6 to 13 ± 3.2 (p <  0.001), increase of PaO2 from 42.4 ± 13.5 to 78 ± 11.5 mmHg (<0.001), and reduction of FiO2 from 1.0 ± 0 to 0.3 ± 0.06 (<0.001). OI decreased by 6.3 % from baseline after the first dose of sildenafil and continued to decrease with subsequent doses. In 6 patients (22%) sildenafil did not work; 5/6 patients (18%) transferred to another tertiary NICU and one patient (4%) died of sepsis. None of the patients had significant systemic hypotension.


CONCLUSIONS
Oral sildenafil is a promising pulmonary vasodilator in patients with PPHN, particularly in medical facilities with no available iNO and ECMO. It is well tolerated with no significant short term complications.
Department of Pediatrics, Children and Women's University Hospital, Minia University, El-Minia, Egypt.
A
A
Sayed
Department of Clinical and Chemical Pathology, Cairo University, Cairo, Egypt.
N
N
Bisheer
D000284:Administration, Oral; D001794:Blood Pressure / Q000187:drug effects; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D010547:Persistent Fetal Circulation Syndrome / Q000188:drug therapy*; D000068677:Sildenafil Citrate / Q000008:administration & dosage*; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage*
D001993:Bronchodilator Agents; D014665:Vasodilator Agents; D000068677:Sildenafil Citrate
NICU; Newborn; PPHN; inhaled nitric oxide; pulmonary vasodilator