This study compared the efficacy of two animal-derived surfactants, poractant alfa and beractant, in treating respiratory distress syndrome (RDS) in preterm infants. The study found that infants treated with poractant alfa required significantly less oxygen in the first 5 days after treatment compared to those treated with beractant. Infants in the poractant alfa group also had higher rates of extubation within 3 days. Additionally, poractant alfa treatment resulted in fewer infants requiring multiple doses of surfactant compared to beractant treatment. While mortality and other outcomes were similar between groups, survival without bronchopulmonary dysplasia at the end of the study period was significantly higher

1. Original Article
A Randomized, Controlled Trial of Poractant Alfa
versus Beractant in the Treatment of Preterm
Infants with Respiratory Distress Syndrome
Evrim Alyamac Dizdar, M.D. 1 Fatma Nur Sari, M.D. 1 Cumhur Aydemir, M.D. 1
Omer Erdeve, M.D. 1 Nurdan Uras, M.D. 1 Ugur Dilmen, M.D. 1
Teaching Hospital, Ankara, Turkey.
Am J Perinatol
Abstract
Keywords
►
►
►
►
beractant
poractant alfa
preterm
respiratory distress
syndrome
► surfactant
Address for correspondence and reprint requests Evrim Alyamac
Dizdar, M.D., Neonatal Intensive Care Unit, Zekai Tahir Burak Maternity
and Teaching Hospital, 06111 Hamamonu, Ankara, Turkey
(e-mail: drevrim@yahoo.com).
We prospectively evaluated the differences in clinical responses and short-term outcomes in preterm infants with respiratory distress syndrome (RDS) treated with
poractant alfa or beractant. Premature infants with RDS were randomized to poractant
alfa or beractant treatment between July 2008 and June 2009. Patients were followed
until 40 weeks of corrected gestational age or death. The fraction of inspired oxygen
(Fio2) after surfactant treatment, need for repeat doses, and duration of respiratory
support and hospitalization were evaluated between groups. Sixty-one infants received
poractant alfa and 65 received beractant. Significantly more patients in the beractant
group required !2 doses of surfactant compared with the poractant alfa group (31%
versus 12%, p ¼ 0.023). Extubation rate within the first 3 days after surfactant
administration was higher in the poractant alfa group than in the beractant group
(81% versus 55.9%, p ¼ 0,004). Posttreatment Fio2 requirement in the poractant alfa
group was significantly lower than in the beractant group on days 1, 3, and 5. Overall
mortality and morbidities were similar between groups. Survival free of bronchopulmonary dysplasia (BPD) at the end of study period was 78.7% and 58.5% in poractant alfa
and beractant groups, respectively (p ¼ 0.015). Our study confirms the rapid onset of
action, less need for redosing, rapid extubation, and higher survival free of BPD in
preterm infants treated with poractant alfa.
Respiratory distress syndrome (RDS) is an important cause of
mortality and morbidity in preterm infants, despite the major
advances in perinatal care and increasing use of antenatal
steroids to accelerate lung maturity. RDS occurs in almost 50%
of preterm infants born at <30 weeks’ gestation.1 The biochemical abnormality in RDS is insufficient production of
surfactant, which leads to poor compliance of lungs, inadequate gas exchange, and need for high ventilatory pressures.
Surfactant therapy has been available since the 1980s and is
well known to improve lung function and to reduce morbidity
and mortality in newborns with or at risk for RDS.2
Surfactant is mainly composed of dipalmitoylphosphatidylcholine (DPPC) and surfactant proteins (SPs), SP-A, SP-B,
SP-C and SP-D. Among the SPs, the lipid soluble SPs, namely,
SP-B and SP-C, play a major role in rapid adsorption and
spreading of DPPC at the air–liquid interphase, resulting in
lower surface tension. Beside SPs, plasmalogen is an antioxidant phospholipid component of surfactant that has
been shown to act synergistically with SP-B in the adsorption and spreading of DPPC.3 There are two types of
surfactants—animal derived and synthetic—that are free of
proteins. Randomized controlled trials have shown that
received
April 21, 2011
accepted after revision
July 5, 2011
Copyright © 2012 by Thieme Medical
Publishers, Inc., 333 Seventh Avenue,
New York, NY 10001, USA.
Tel: +1(212) 584-4662.
DOI http://dx.doi.org/
10.1055/s-0031-1295648.
ISSN 0735-1631.
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1 Neonatal Intensive Care Unit, Zekai Tahir Burak Maternity and
Serife Suna Oguz, M.D. 1

2. Poractant Alfa versus Beractant in the Treatment of RDS
Dizdar et al.
animal-derived surfactants are better than synthetic surfactants during the acute phase of RDS, with lower mortality in favor of animal-derived surfactants. At present, there is
no synthetic surfactant available for the treatment of RDS in
preterm infants. Animal-derived surfactants are produced
from bovine or porcine lungs and contain different amounts
of DPPC, SP-B, SP-C, and plasmalogens. Three animal-derived surfactant preparations commonly used worldwide
include beractant (BE), calfactant (CA), and poractant alfa
(PA). BE is a minced bovine lung extract and contains 84%
phospholipids and 1.5 mol% plasmalogens. CA is a lavage
preparation from bovine lung and contains more SP-B and
phospholipids than BE. PA is a concentrated, minced porcine
surfactant that contains pure polar lipids and the highest
amount of plasmalogens (3.8 mol%).3,4
Four randomized controlled clinical trials comparing BE
and CA have shown no significant differences in the need for
redosing, short- or long-term outcomes, or mortality.5,6 In
one study, treatment with CA was associated with faster
weaning from respiratory support when compared with BE,
and a statistically significant reduction in mortality was
shown in another study in the BE-treated group in infants
with birth weight <600 g.5
Given the significant differences in composition and biochemical properties between BE and PA, we aimed to evaluate
whether there were any differences in the efficacy and shortterm outcomes between these two animal-derived surfactants in a large population of preterm patients with RDS.
followed until 40 weeks of corrected gestational age or death.
Posttreatment Fio2 values, duration of intubation, nasal continuous positive airway pressure (CPAP) ventilation, supplemental O2 support, total respiratory support (the sum of
mechanical ventilation days þ nasal CPAP days þ O2 support
days), and total duration of hospitalization were recorded and
compared between the two groups.
The groups were also compared regarding the following
NICU-related complications diagnosed within 40 weeks of
corrected gestational age: pneumothorax, patent ductus arteriosus (PDA), intraventricular hemorrhage (IVH), pulmonary hemorrhage, sepsis, bronchopulmonary dysplasia (BPD),
retinopathy of prematurity (ROP), necrotizing enterocolitis
(NEC), and death.
This prospective randomized study was performed in Zekai
Tahir Burak Maternity Teaching Hospital Neonatal Intensive
Care Unit (NICU). Infants were eligible for the study when the
following inclusion criteria were met: gestational age <37
weeks, clinical and radiological diagnosis of RDS within 6
hour of birth, fraction of inspired oxygen (Fio2) !0.30 to
maintain oxygen saturation by pulse oximeter of 88 to 96%.
Infants with congenital heart and lung diseases or abdominal
wall pathology were excluded. Patients were randomized to
receive either 100 mg/kg BE or 200 mg/kg PA via the endotracheal tube for the initial dose. Additional doses of surfactant were given if the infant required ventilator support and if
Fio2 !0.30 was required to maintain the oxygen saturation
!88% by pulse oximetry. Retreatment with 100 mg/kg of BE
or PA per dose was performed in accordance with the
manufacturer’s drug package insert. Informed parental consent was obtained for all study infants. The study was
approved by the institutional review board of the hospital
and financially supported by Hospital Research Foundation.
The cost of the drugs were 380$ for 120 mg/1.5 mL vial of PA
and 392$ for 800 mg/8 mL vial of BE.
Patient characteristics including gestational age, gender,
birth weight, presence of perinatal asphyxia, Apgar scores,
and maternal risk factors including prenatal steroid administration, preterm prolonged rupture of membranes, chorioamnionitis, preeclampsia, route of delivery, and multiple
pregnancy were collected for all infants. Patients were
American Journal of Perinatology
RDS was defined clinically as the presence of tachypnea
with retractions, nasal flaring, expiratory grunting, and
cyanosis in room air and with chest radiograph that showed
diffuse reticulogranular opacities and air bronchogram. BPD
was diagnosed by using the U.S. National Institutes of
Health diagnostic criteria for BPD.7 Sepsis was defined as
presence of clinical signs of systemic infection with positive
blood culture. IVH was graded according to the classification
of Papile and coworkers.8 PDA was considered significant if
the patency of the ductus was confirmed by the echocardiogram with ductal size >2 mm and left atrial diameter/
aortic root ratio of >1.5 together with left ventricular
enlargement. NEC was classified according to the classification of Bell and colleagues.9 An experienced ophthalmologist confirmed the diagnosis of ROP by using international
classification of ROP.10
Statistical Analyses
The primary outcome of our study was Fio2 at 24 hours
postgestation. It was determined that 51 patients per group
were necessary to detect a 10% difference in Fio2 at 24 hours
postgestation between surfactant groups, with an α of 0.05
and a power of 0.80. Descriptive analysis was performed for
demographic and clinical characteristics of the patients.
Student t test or Mann-Whitney U test was used for comparison of numeric variables between two groups, and chi-square
test was used for comparison of ratios between the groups.
Spearman test was used for correlation analysis. Statistical
analysis was performed with SPSS software version 13.0
(SPSS Inc., Chicago, IL), and statistical significance was set at
p < 0.05.
Results
A total of 126 preterm infants with RDS were included in the
study. Sixty-five infants received BE, and 61 infants received
PA. Patient characteristics are shown in ►Table 1. There were
no significant differences between the patient groups with
regards to gestational age, birth weight, gender, Apgar scores,
mode of delivery, maternal age, or antenatal steroid administration rates. More patients in the PA group were born from
multiple-birth pregnancies. More patients in the BE group
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Patients and Methods
Study Definitions

3. Poractant Alfa versus Beractant in the Treatment of RDS
Dizdar et al.
Table 1 Patient Characteristics (n ¼ 126)
Poractant Alfa (n ¼ 61)
Beractant (n ¼ 65)
p
Gestational age (wk), median (range)
28 (25–36)
28 (23–36)
NS
Birth weight (g), median (range)
1165 (620–2290)
1080 (510–2750)
NS
Male gender, n (%)
31 (51%)
42 (65%)
NS
Apgar score at 1 min, median (range)
5 (1–7)
4 (1–7)
NS
Apgar score at 5 min, median (range)
7 (3–9)
7 (2–9)
NS
Surfactant treatment, n (%)
One dose
Two doses
Three doses
54 (88%)
7 (12%)
—
45 (69%)
18 (28%)
2 (3%)
Maternal age (y), median (range)
27 (19–40)
29 (18–40)
0.023
NS
52 (85%)
51 (78%)
NS
Multiple pregnancy, n (%)
33 (54%)
21 (32%)
0.011
Antenatal steroid use, n (%)
37 (63%)
33 (51%)
NS
Preeclampsia, n (%)
3 (5%)
9 (14%)
NS
required !2 doses of surfactant compared with PA group (31%
versus 12%, respectively, p ¼ 0.023).
Mean Fio2 requirement in the PA-treated group was
significantly lower than in the BE-treated group on days 1,
3, and 5 but was similar on days 7, 14, and 28 (►Fig. 1).
Extubation rate within the first 3 days after surfactant
administration was higher in the PA group than in the BE
group (81% versus 55.9%, p ¼ 0.004).
Overall mortality was similar between the groups. Other
follow-up outcomes including BPD rates, duration of intubation, days on nasal CPAP, O2 supplementation and total
respiratory support, hospitalization period, and development
of complications such as pneumothorax, pulmonary hemorrhage, ROP, sepsis, NEC, and IVH were also similar between
the two groups (►Tables 2 and 3). Survival free of BPD at the
end of the study period was 78.7% versus 58.5% in PA- and BEtreated groups, respectively (p ¼ 0.015).
Figure 1 Post surfactant mean fraction of inspired oxygen (Fio2 )
requirement in patients treated with beractant and poractant alfa (PA).
Mean Fio 2 requirement was less in the PA-treated group on days 1, 3,
and 5 (p < 0.05). Error bars denote range.
Discussion
In this study, we found that treatment with PA was associated
with lower Fio2 requirements within the first 5 days in infants
with RDS as well as higher rates of extubation within the first
3 days compared with BE. The need for additional doses was
significantly less among the infants treated with PA compared
with those treated with BE. Survival free of BPD was significantly higher in the PA group than in the BE group, although
the study was not powered to detect differences in this
outcome. No differences in mortality or other outcomes
were seen between the two groups.
Although exposure to oxygen is essential for the survival of
infants with RDS, it may result in oxidative stress and
development of chronic lung disease, which may lead to
substantial mortality and morbidity in preterm infants.11
Therefore, faster weaning of oxygen is crucial to reduce
lung injury in preterm infants. Surfactant treatment is the
standard of care in the treatment of RDS and effectively
reduces associated morbidity and mortality. In a meta-analysis conducted by the Committee of the Fetus and Newborn of
the American Academy of Pediatrics, attributed reductions in
the mortalities of RDS patients to surfactant were as follows:
odds ratios of 0.6 for agents of animal origin and 0.7 for those
of synthetic origin when administered with prophylactic
intent, and 0.67 for agents of animal origin and 0.73 for those
of synthetic origin when administered as rescue therapies.12
Animal-derived surfactants have been demonstrated to
result in a greater improvement in the severity of RDS
compared with synthetic surfactants in clinical trials. Therefore, natural surfactants are used during the acute phase of
RDS almost exclusively.13 There are significant differences in
the composition, phospholipid and plasmalogen content, SP
content, viscosity, volume of administration, and onset of
action among the different animal-derived surfactants. These
American Journal of Perinatology
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Cesarean section, n (%)

4. Poractant Alfa versus Beractant in the Treatment of RDS
Dizdar et al.
Table 2 Pulmonary and Other Outcomes
Poractant Alfa (n ¼ 61)
Beractant (n ¼ 65)
p
Extubation within first 3 d (%)
81
55.9
0.004
Reintubation for respiratory distress within first 14 d (%)
24.5
38.8
NS
4.8 (10.5)
4.2 (4.3)
NS
NCPAP (d)
5.9 (13.6)
4.7 (4.7)
NS
O2 by hood (d)
2.0 (4.5)
3.1 (3.9)
NS
Free O2 supplementation (d)
7.8 (11.7)
9.3 (15.0)
NS
Total respiratory support (d)
20.1 (27.3)
20.7 (21.5)
NS
Dopamine infusion (d)
6.6 (6.1)
8.0 (7.17)
NS
Day 1 Fio2
60.5 (14.2)
67.4 (15.0)
0.031
Day 3 Fio2
43.9 (18.5)
58.6 (19.7)
0.001
Day 5 Fio2
36.5 (16.7)
44.2 (15.9)
0.044
Day 7 Fio2
30.5 (12.2)
34.2 (12.5)
NS
Day 14 Fio2
25.3 (8.7)
28.7 (11.1)
NS
Day 28 Fio2
24,2 (7.7)
24,3 (10.0)
NS
Initiation of oral feeding (d)
2.24 (0.9)
2.38 (1.6)
NS
Initiation of full feeding (d)
17.5 (9.2)
22.3 (16.2)
NS
Days of hospitalization
37.7 (24.4)
40.1 (30.9)
NS
9.8
20
NS
Mortality rate (%)
Ã
Data are mean (standard deviation) unless noted otherwise. Fio2, fraction of inspired oxygen; NCPAP, nasal continuous positive airway pressure.
properties are likely the reason for the differences in outcomes seen in comparative clinical trials. PA contains the
highest amount of phospholipids distributed in the lowest
volume (80 mg/mL) and highest amount of plasmalogens
(3.8%). Plasmalogens are antioxidant phospholipids that help
to protect against oxidative stress, which is very important in
preterm infants with low antioxidant activity.13 BE contains
84% phospholipids and 1.5% plasmalogens. PA contains more
SP-B and less SP-C compared with BE.3
Five randomized controlled trials comparing BE and
PA have been published since 1995.2,14–17 In a pilot
study comparing PA (200 mg/kg for the first dose) and BE
(100 mg/kg for the first dose), Speer et al showed treatment
with PA resulted in faster weaning of oxygen and lower
requirement of peak inspiratory pressure and mean airway
pressure 24 hours after administration.14 Baroutis et al
showed that infants treated with PA 100 mg/kg/dose had a
shorter ventilator course, required oxygen for fewer days, and
had a shorter length of stay in hospital than infants treated
with BE 100 mg/kg/dose.15 Ramanathan et al showed faster
weaning of oxygen and fewer doses with PA treatment when
compared with BE.2 In addition, they found that mortality
decreased from 11% in infants <32 weeks treated with BE
(100 mg/kg) to 3% in infants treated with the higher initial
dose of PA (200 mg/kg). This improvement in mortality is
likely related to the larger initial dose of PA, rather than to an
intrinsic difference in the properties of the surfactant itself. In
the study by Malloy et al, preterm infants with RDS (n ¼ 58)
Table 3 Adverse Outcomes
Poractant Alfa (n ¼ 61)
Beractant (n ¼ 65)
p
Pneumothorax
7.1%
4.9%
NS
Pneumonia
7.1%
13.3%
NS
Pulmonary hemorrhage
7.1%
6.5%
NS
Intraventricular hemorrhage
22%
13,8%
NS
Patent ductus arteriosus
54.9%
70.6%
NS
Sepsis
43.6%
57.1%
NS
Necrotizing enterocolitis
13.5%
5.6%
NS
BPD-free survival
78.7%
58.5%
0.015
All data are (%). BPD, bronchopulmonary dysplasia.
American Journal of Perinatology
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Ventilation (d)

5. PA, poractant alfa; BE, beractant; BPD, bronchopulmonary dysplasia.
Dizdar et al
Dizdar et al.
who were treated with PA had a lower Fio2 requirement than
those treated with BE within the first 48 hours following
surfactant administration.16 This study extended the findings
of improved oxygenation following treatment with PA up to
48 hours, whereas the earlier studies reported improvements
in oxygenation up to 6 or 24 hours after surfactant administration.2,14 A meta-analysis of these two trials showed an
odds ratio for mortality of 0.31 (95% confidence interval 0.010
to 0.98).18 Recently, Fujii et al compared BE and PA in 52
preterm infants with RDS and showed that treatment with PA
was associated with faster weaning of oxygen and lower
mean airway pressure requirement to maintain adequate
oxygenation. Significantly higher proportion of infants
were extubated in the PA-treated group 48 and 72 hours
after surfactant administration.17 Interestingly, they also
found a lower incidence of PDA and air leaks among the
PA-treated infants.19
Our findings also showed lower oxygen need in infants
treated with PA within the first 5 days. Mean Fio2 requirements were similar on days 7, 14, and 28. Extubation rate
within the first 3 days after surfactant administration, which
is a marker of early recovery, was also higher in the PA-treated
group than in the BE-treated group. Mortality rate was similar
in our study in the two groups. However, we found survival
free of BPD to be higher in the PA group than in the BE group.
As BPD is defined as the need for oxygen at 36 weeks’
postmenstrual age and >28 days of age, infants who die
within this period are excluded when determining BPD rates.
This may result in exclusion of a subgroup with high frequency of respiratory problems and high risk of developing BPD if
they lived longer. Therefore, we believe that “survival free of
BPD” is a more rational outcome, and we showed that PA is
more efficacious in this regard. A meta-analysis of randomized trials comparing these surfactants also showed a mortality difference (odds ratio 0.35; 95% confidence interval 0.13
to 0.92).18 However, the numbers of patients were relatively
small, and the recent American Academy of Pediatrics recommendations state: ‘‘It is unclear whether significant differences in clinical outcomes exist among the available [animalderived surfactant] products.”12
Infants needed lower additional doses in the PA-treated
group when compared with the infants in the BE-treated
group in the two trials reported before.2,16 In our study, 88% of
infants treated with PA required only one dose of surfactant.
The PA-treated group required less additional doses of surfactant compared with the BE-treated group. Ramanathan
et al2 explained this finding due to the larger initial dose of PA
compared with BE in their study. We also used 200 mg/kg PA
initially in our study.
Caution should be exercised when interpreting our results
in comparison with other randomized studies of BE and PA.
Although not statistically significant, differences in the baseline characteristics of the treatment groups in our study
might have influenced the results given the small sample
size and should be noticed as a limitation. Second, although
our study and all the previous studies comparing BE and PA
included preterm infants with RDS, baseline demographics
differed significantly among the studies; for instance, median
American Journal of Perinatology
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9.8 versus 20
15 versus 28
63 versus 51
51 versus 65
28 versus 28
1165 versus 1080
PA 200 versus BE
13 versus 18
35 versus 50
100 versus 96
48 versus 74
27.1 versus 26.7
930 versus 900
19 versus 23
0 versus 10
34 versus 37
69 versus 79
48 versus 45
29.6 versus 29.3
1394 versus 1408
PA 200 versus BE
PA 200 versus BE
Fujii et al
17
Malloy et al
16
3 versus 12.5
12.5 versus 11.4
14.8 versus 15.4
26 versus 31
42 versus 37
33 versus 55
59 versus 38
28.7 versus 29.2
28.8 versus 28.9
PA 200 versus BE
Baroutis et al15
1233 versus 1180
PA 200 versus BE
Speer et al14
1095 versus 1082
3 versus 6 versus 8
50 versus 49 versus 50
82 versus 76
versus 85
58 versus 61
versus 56
28.8 versus 28.7
versus 28.7
1148 versus 1151
versus 1187
PA 100 versus PA 200
versus BE
Ramanathan
et al2
Gestational age, wk (Mean)
Birth Weight,
g (Mean)
Table 4 Patient Characteristics and BPD/Death Rates in Randomized Studies of PA versus BE
Gender
(% Male)
Antenatal
Steroid (%)
BPD (%)
Death (%)
Poractant Alfa versus Beractant in the Treatment of RDS

6. birth weight was $900 g in the study of Fujii et al 17 versus
$1200 g in the study of Baroutis et al 15 versus $1100 g in our
study. Malloy et al’s study 16 and ours had broader ranges of
birth weight and gestational age compared with the remaining studies, and this might lead to heterogeneity as a source of
bias. Other demographics and related clinical outcomes including gender distribution, antenatal steroid use, and rates
of death and BPD also differed significantly between study
groups (►Table 4). This heterogeneity might be secondary to
the differences in patient characteristics as well as intercenter
differences, as demonstrated by Ambalavanan et al, who
found that center differences were significantly associated
with BPD/death rates even after correction for clustered
infant-level variables.20
In summary, our data indicate that preterm infants with
RDS treated with PA have a more favorable outcome regarding
lower oxygen need and faster weaning from mechanical
ventilation as shown by higher extubation rate within
3 days of surfactant treatment compared with BE. Survival
rates were similar. This study and the previous studies
consistently delineate some clinical benefit with the use of
PA over BE. However, larger studies are necessary to confirm
the impact on BPD and/or mortality as a primary outcome
between the different animal-derived surfactants.
Dizdar et al.
5
6
7
8
9
10
11
12
13
Acknowledgments
We would like to thank to Zekai Tahir Burak Maternity
Teaching Hospital Research Foundation for financial support and Professor Rangasamy Ramanathan for his
thoughtful contributions to our study.
14
15
16
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