Format

Send to

Choose Destination
J Pediatr. 2009 Dec;155(6):841-847.e1. doi: 10.1016/j.jpeds.2009.06.012.

Intravenous sildenafil in the treatment of neonates with persistent pulmonary hypertension.

Author information

1
Department of Pediatrics, Northwestern University Feinberg School of Medicine and Children's Memorial Hospital, Chicago, IL 60614, USA. r-steinhorn@northwestern.edu

Abstract

OBJECTIVE:

To evaluate the safety of intravenous (IV) sildenafil, an inhibitor of cyclic guanosine monophosphate-specific phosphodiesterase, in treating near-term and term newborns with persistent pulmonary hypertension of the newborn (PPHN).

STUDY DESIGN:

This was an open-label, dose-escalation trial in newborns with PPHN and an oxygenation index (OI) > 15. Sildenafil was delivered by continuous IV infusion for at least 48 hours and up to 7 days.

RESULTS:

Five centers enrolled a total of 36 neonates with PPHN at a mean of 34 +/- 17 hours of age; 29 of these neonates were already receiving inhaled nitric oxide (iNO). A significant improvement in OI (28.7 to 19.3; P = .0002) was observed after 4 hours of sildenafil infusion in the higher dose cohorts. Thirty-five neonates survived; 1 neonate required extracorporeal membrane oxygenation (ECMO) support. In 4 neonates, sildenafil was stopped due to adverse events. Seven neonates were enrolled before developing the need for iNO. In these neonates, OI improved significantly by 4 hours after initiation of sildenafil infusion (24.6 to 14.7; P = .009); 6 neonates completed treatment without the need for iNO or ECMO.

CONCLUSIONS:

IV sildenafil was well tolerated, and acute and sustained improvements in oxygenation were noted in those neonates who received the higher infusion doses.

PMID:
19836028
DOI:
10.1016/j.jpeds.2009.06.012
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center