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Safety of epoprostenol and treprostinil in children less than 12 months of age.
[congenital diaphragmatic hernia]
There
is
a
paucity
of
data
on
infant
intravenous
prostacyclin
use
,
the
gold
standard
for
therapy
for
severe
pulmonary
hypertension
(
PH
)
.
This
review
aimed
to
evaluate
the
safety
,
tolerability
,
and
outcomes
of
infant
prostacyclin
use
.
A
retrospective
observational
study
was
performed
in
a
large
pediatric
hospital
with
a
dedicated
pediatric
PH
program
.
Subject
medical
records
,
bedside
flow
sheets
,
and
progress
notes
were
reviewed
to
identify
use
of
intravenous
epoprostenol
or
treprostinil
within
the
first
year
of
life
.
The
indication
for
prostacyclin
use
was
recalcitrant
hemodynamic
compromise
associated
with
PH
,
identified
as
either
idiopathic
PH
,
persistent
PH
of
the
newborn
,
PH
associated
with
congenital
diaphragmatic
hernia
,
congenital
heart
disease
,
bronchiolitis
,
or
chronic
lung
disease
.
Prostacyclin-related
adverse
events
included
7
episodes
of
hypotension
,
6
episodes
of
perceived
pain
,
2
episodes
of
cyanosis
,
and
1
episode
of
feeding
intolerance
.
Prostacyclin
was
stopped
only
for
cyanotic
episodes
associated
with
use
in
severe
chronic
lung
disease
.
Two
hemorrhagic
events
occurred
during
extracorporeal
membrane
oxygenation
,
which
were
unlikely
to
be
prostacyclin
related
.
Outcomes
included
21
deaths
unrelated
to
prostacyclin
,
1
lung
transplant
,
6
PH
resolutions
,
8
transitions
to
oral
PH
medications
,
and
1
continuation
of
treprostinil
.
In
conclusion
,
efficacy
could
not
be
evaluated
in
this
study
because
of
the
loss
of
equipoise
for
neonatal
prostacyclin
use
.
Prostacyclin
use
was
well
tolerated
in
neonatal
diseases
associated
with
PH
,
but
dose
titration
was
limited
by
hypotension
and
hypoxemia
.
Diseases
Validation
Diseases presenting
"use in severe chronic lung disease"
symptom
congenital diaphragmatic hernia
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