Journal Club PDA
Journal Club PDA
Journal Club PDA
-ANIRUDHA GARDE
Introduction
Aim :
Hypothesis:
METHODS
Study design Prospective randomized non-blinded, parallelcontrolled and non-inferiority clinical trial
Approval - Hospital Ethics Committee of the
First Hospital of Jilin University (No.2012-057).
Consent Written and informed consent from parents
Inclusion criteria:
gestational age 34 weeks; postnatal age 14 days;
echocardiographic diagnosis of hemodynamically significant PDA.
Exclusion criteria:
Study Design
Main outcome: were the rates of ductal closure of both drugs after
treatment. Every infant was monitored by echocardiography daily
during the treatment.
Statistical Analysis
SPSS software (version 20.0) was used for all statistical analyses.
Results
Baseline Characteristics
Between May 21, 2012 and March 30, 2013, 1279 preterm infants
were treated in our hospital, including 913 infants (71.3%) born at
gestational age 34 weeks. A total of 249 infants (81.1%) met the
enrollment criteria, of whom 89 were excluded (Fig.1). No
significant differences in baseline clinical characteristics were
observed between the two groups (Table 1).
P value
30.92.2
31.2 1.8
0.474
1531.0 453.5
1591.9 348.6 g
0.342
Male
42
41
female
38
39
48(60%)
52(65%)
0.447
PIH, n (%)
33(41.2%)
34(42.5%)
0.873
45(56.2%)
47(58.8%)
0.749
10(12.5%)
11(13.8%)
0.815
11(13.8%)
10(12.5%)
0.815
38(47.5%)
39(48.8%)
0.874
NCPAP, n (%)
52(65.0%)
58(72.5%)
0.306
NSIMV, n (%)
31(38.8%)
29(36.2%)
0.744
SIMV, n (%)
10(12.5%)
12(15.0%)
0.646
11(13.8%)
9(11.3%)
0.633
2.360.49
2.410.44
0.805
LA/Ao
1.600.27
1.670.23
0.103
191.930.0
190.8 27.5
0.459
Efficacy of Treatment
The ductus was closed in 65 infants (81.2%) of the paracetamol
group compared with 63 (78.8%) of the ibuprofen group and
there was no significant difference between the two treatments
(P =0.693).
Meanwhile, the 95% CI for the difference between the
two groups was [-0.080, 0.128]. Thus, the efficacy of paracetamol
was non-inferior to the ibuprofen group.
After the 1st course of treatment, ductal closure occurred in 45
infants (56.3%) given paracetamol and in 38 infants (47.5%)
administered ibuprofen (P=0.268).
Reopening of the ductus after closure occurred in five
infants of the paracetamol group and in six of the ibuprofen group.
After continuing to receive the assigned drug treatment, the ductus
closed again in four patients of each group (Table 2).
P value
5(7.7%)
6(9.5%)
0.712
Reclosure rate
4 (80%)
4(66.7%)
0.621
3.220.14
3.710.16
0.020
Safety of Treatment
P value
Oliguria
0.42
Renal failure
0.32
NEC
0.65
IVH 12
0.77
IVH 34
Hyperbilirubinemia
16
28
0.03
Gastrointestinal bleeding
0.03
61.6214.53
62.4015.24
0.74
BPD
0.73
PVL
0.59
NEC
0.65
ROP
0.60
Sepsis
18
23
0.37
Death
10
12
0.65
Early outcomes
Late outcomes
Discussion
This current study has provided several important implications for the clinical
treatment of PDA. First, it demonstrated that
paracetamol may become the choice drug for PDA in preterm
infants.
Furthermore, the mean days to closure were shorter in the paracetamol group than
in the ibuprofen group (3.22 0.14 days
vs. 3.71 0.16 days, P= 0.020), indicating that paracetamol can
treat PDA more rapidly compared with ibuprofen and be better
suited for severe cases in which quick relief of symptoms is
needed.
Finally, the incidence rates of gastrointestinal bleeding and hyperbilirubinemia in
the paracetamol group were significantly lower than those of the ibuprofen group.
So, paracetamol may be indicated for PDA in preterm infants with
hyperbilirubinemia.
Limitations
Conclusions
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