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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
"prenatal diagnosis"
symptom
22q11.2 deletion syndrome
achondroplasia
adrenomyeloneuropathy
alexander disease
alpha-thalassemia
aromatase deficiency
benign recurrent intrahepatic cholestasis
cadasil
canavan disease
classical phenylketonuria
cohen syndrome
congenital adrenal hyperplasia
congenital diaphragmatic hernia
congenital toxoplasmosis
cystinuria
dentinogenesis imperfecta
epidermolysis bullosa simplex
harlequin ichthyosis
holt-oram syndrome
homocystinuria without methylmalonic aciduria
hydrocephalus with stenosis of the aqueduct of sylvius
junctional epidermolysis bullosa
kindler syndrome
krabbe disease
lamellar ichthyosis
megacystis-microcolon-intestinal hypoperistalsis syndrome
monosomy 21
neonatal adrenoleukodystrophy
oculocutaneous albinism
omenn syndrome
phenylketonuria
primary hyperoxaluria type 1
pyruvate dehydrogenase deficiency
severe combined immunodeficiency
wolf-hirschhorn syndrome
x-linked adrenoleukodystrophy
zellweger syndrome
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