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Epoprostenol Does Not Affect Mortality in Neonates with Congenital Diaphragmatic Hernia.
[congenital diaphragmatic hernia]
Purpose
Epoprostenol
(
also
called
prostaglandin
,
PGI
)
is
used
for
pulmonary
hypertension
in
newborns
with
congenital
diaphragmatic
hernia
(
CDH
)
in
some
centers
.
The
effects
of
PGI
on
survival
in
newborns
with
CDH
were
examined
.
Methods
A
retrospective
analysis
of
the
Congenital
Diaphragmatic
Hernia
Study
Group
registry
between
2007
and
2011
was
performed
.
Patient-level
logistic
regression
was
applied
in
a
subset
of
29
hospitals
with
a
history
of
PGI
use
to
relate
the
probability
of
death
to
the
use
of
PGI
within
7
days
of
surgery
after
controlling
for
ethnicity
,
prenatal
diagnosis
,
prenatal
steroids
,
CDH
defect
,
chromosomal
abnormalities
,
liver
location
,
complex
cardiac
anomalies
,
5
-
minute
Apgar
score
,
and
operative
day
of
life
.
This
analysis
was
repeated
after
excluding
50
%
of
the
patients
with
the
lowest
probabilities
(
<
0
.
042
mean
propensity
score
)
of
receiving
treatment
.
To
reduce
confounding
by
indication
,
a
separate
mixed
effects
logistic
regression
analysis
was
performed
in
58
hospitals
to
relate
the
hospital-level
mortality
to
the
proportion
of
patients
administered
PGI
after
controlling
for
hospital-level
covariates
.
Results
Epoprostenol
was
administered
within
7
days
of
surgery
for
80
(
7
.
3
%
)
of
these
subjects
.
Epoprostenol
use
was
associated
with
higher
mortality
(
odds
ratio
[
OR
]
4
.
39
,
95
%
confidence
interval
[
CI
]
2
.
04
-
9
.
48
)
in
the
patient-level
analyses
without
covariate
adjustment
.
The
direct
association
of
epoprostenol
use
with
mortality
was
partially
reduced
after
covariate
adjustment
(
adjusted
OR
2
.
24
,
95
%
CI
0
.
95
-
5
.
29
,
p
=
0
.
07
)
,
and
further
attenuated
after
both
covariate
adjustment
and
restriction
of
the
analysis
to
patients
with
propensity
scores
>
0
.
042
(
adjusted
OR
1
.
71
,
95
%
CI
0
.
68
-
4
.
29
,
p
=
0
.
26
)
.
A
total
of
182
of
the
1
,
639
patients
included
in
the
center-level
dataset
died
after
7
days
of
operation
.
There
was
no
statistically
significant
association
of
mortality
with
the
proportion
of
patients
administered
epoprostenol
in
hospital-level
analysis
(
adjusted
OR
0
.
63
,
95
%
CI
0
.
34
-
1
.
17
per
25
%
increase
,
p
=
0
.
15
)
.
Conclusion
The
discrepancy
of
results
between
the
hospital
and
patient-level
analyses
suggests
that
the
association
of
mortality
and
PGI
in
the
patient-level
analyses
resulted
from
bias
by
indication
.
Hospital
-level
results
provided
no
evidence
of
a
benefit
of
PGI
use
on
survival
,
but
may
have
failed
to
detect
a
true
benefit
due
to
limited
statistical
power
.
Further
use
of
PGI
in
this
population
should
only
be
recommended
after
rigorous
evaluation
,
such
as
a
randomized
controlled
trial
.
Diseases
Validation
Diseases presenting
"pulmonary hypertension in newborns"
symptom
congenital diaphragmatic hernia
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