1. Original Article
Complications among Premature Neonates Treated with
Beractant and Poractant Alfa
Manizheh Mostafa Gharehbaghi, Seddigheh Hossein Pour Sakha, Mortaza Ghojazadeh1 and Farahnaz
Firoozi
Department of Neonatology and Pediatrics, and 1Department of Physiology, Tabriz University, Medical Sciences,
Tabriz, Iran
ABSTRACT
Objective. To compare the complications among preterm infants treated with two different natural surfactants.
Methods. In a randomized clinical trial, 150 preterm infants with Respiratory distress syndrome (RDS) treated with exogenous
surfactant, were enrolled in the study. Group A consisted of 79 neonates that received poractant (curosurf). Seventy one
newborn infants in group B were treated with beractant (Survanta).
Results. The mean gestational age for group A and B were 29.40±2.90 wk and 29.50±2.73 wk (P=0.82), respectively. The
demographic and clinical variables were similar in both groups. The mean duration of intubation (as a primary outcome) was
significantly shorter in infants treated with poractant (3.13±1.80 vs 4.06±2.7 days p=0.05). The mean duration of need for
oxygen and hospitalization of patients in group A and B were 17.73±22.25 vs 19.14±17.85days (p=0.67) and 24.89±26.41 vs
29.14±23.54 days (p= 0.32), respectively. There was no significant difference between groups with respect to mortality and
morbidity, including pulmonary hemorrhage, intraventricular hemorrhage (IVH), patent ductus arteriosus, sepsis, and
bronchopulmonary dysplasia (secondary outcome).
Conclusions. In this study, infants who received poractant had shorter duration of intubation than infants treated with
beractant, without any difference in the duration of oxygen therapy or hospitalization. There was no significant superiority of
poractant over beractant. [Indian J Pediatr 2010; 77 (7) : 751-754] E-mail: gharehbaghimm@yahoo.com
Key words: Poractant; Respiratory distress syndrome; Beractant; Morbidity
Acute respiratory distress syndrome (RDS) secondary to
surfactant deficiency, is a major cause of morbidity in
premature infants. Surfactant lines the alveolar surfaces in
the lungs, thereby reducing surface tension and
preventing atelectasis. Surfactant replacement therapy
reduces the severity of RDS and its mortality.1-3 A wide
variety of surfactant preparations have been developed.
Animal derived surfactants in clinical use are modified or
purified from bovine or porcine lungs and contain
proteins. 1, 2 Beractant (survanta) are lipid extracts of
bovine lung mince, with added dipalmitoyl phosphatidyl
choline (DPPC), tripalmitoyl glycerol, and palmitic acid.
Poractant (curosurf) is a porcine lung mince that has been
subjected to chloroform-methanol extraction and further
purified by liquid gel chromatography. It consists of
Correspondence and Reprint requests : Dr. Manizheh Mostafa
Gharehbaghi, NICU - Al Zahra Hospital, South Arthesh Street
513866449, Tabriz, Iran.
[DOI-10.1007/s12098-010-0097-y]
[Received May 3, 2009; Accepted March 29, 2010]
Indian Journal of Pediatrics, Volume 77—July, 2010
approximately 99% polar lipids (mainly phospholipids )
and 1% hydrophobic low-molecular-weight proteins (SPB,SP-C).4
All commercially available natural surfactants are
effective in prevention and treatment of respiratory
distress syndrome. There are several studies comparing
administration of synthetic surfactants with natural
surfactant extracts in the treatment of RDS in preterm
infants; that showed greater early improvement in the
requirements for ventilator support, fewer air leaks and
fewer deaths associated with natural surfactant
preparations.1,2,4,5 It must be noted that in these studies
synthetic preparations did not contain surfactant protein
analogues. Many natural surfactant products are available
for clinical use. However, it is unclear whether significant
differences exist among the available products. There is
no current evidence establishing the superiority of one or
more natural surfactant products over others. This study
was conducted to compare the effectiveness of two animal
derived surfactants with different extraction and
formulation in the treatment of RDS in preterm infants.
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2. Manizheh Mostafa Gharehbaghi et al
MATERIAL AND METHODS
From March 2008 through Mach 2009, a prospective
masked randomized control trial was conducted in the
neonatal intensive care unit of Al-Zahra Hospital, a
university level III neonatal centre in North West of Iran.
The study was approved by ethics committee of the
university. New born preterm infants diagnosed with
RDS, that required exogenous surfactant replacement
therapy, were eligible for this study. Infants with major
congenital malformations, chromosomal abnormalities,
and severe asphyxia (5-min Apgar score less than 3), were
excluded. They were randomized into two groups by odd
or even number of admission code, after obtaining
informed parental consents. The group A was treated
with poractant alfa (Curosurf, Chiesi farmaceutici, Italy)
200mg/kg (2.5cc/kg) in two divided doses, administrated
by rapid bolus infusion directly in to the distal
endotracheal tube after disconnecting the infant from
ventilator.
The patients in group B was treated with survanta
(beractant, Ross, USA) 100 mg/kg (4cc/kg) in four
divided doses, intratracheally. Exogenous surfactant
replacement therapy was administrated as soon as
possible after intubation and stabilization of newborn
infant after birth. Primary outcome was that the newborn
remained without ventilator support through 7 days of
age. Secondary outcomes included death before discharge
and complications related to either prematurity or RDS,
which included following:
(1) Pulmonary hemorrhage, which was diagnosed by a
rapid deterioration in clinical condition along with
presence of frank blood in the endotracheal tube
(2) Bronchopulmonary dyspasia that was defined as
oxygen dependency beyond 36 wk post conception
age
(3) Patent ductus arteriosus (PDA) was defined as
confirmation of clinical signs of PDA with
echocardiography
(4) Air leak syndromes including pneumothorax, and
pulmonary interstitial emphysema
(5) Retinopathy of prematurity confirmed by
ophthalmologic examination performed by same
ophthalmologist who was blind to surfactant type
received
(6) Severe intra ventricular hemorrhage (grade III or IV)
that was detected by transfontanel ultrasound
evaluation
(7) Sepsis documented by positive blood culture
The diagnosis of morbidities was recorded by two
independent senior attending neonatologists who did not
know the group assignment of the neonates. Infants were
eligible to receive additional doses of surfactant, if they
met following criteria: requirement for assisted
ventilation with Fio2 ≥ 0.50 and radiographic evidence of
752
RDS in presence of continued respiratory distress.
Statistical analysis was performed using the SPSS
package 16. The chi-square (χ2) test was used to analyze
the categorical data along with fisher’s exact test when
applicable; the student’s t test was used for continuous
data.
RESULTS
There were 309 newborn premature infants admitted to
NICU during the one year study period. Of these infants,
120 didn’t develop signs and symptoms of RDS and did
not receive surfactant; 27 infants had Apgar score less
than 3 at 5 min, 12 neonates had major congenital
anomalies. A total of 150 infants had met inclusion criteria
in the study: 79 in group A and 71 in group B. The mean
gestational age and weight of studied infants were
29.45±2.81 wk and 1444.4±585.58 g, respectively. The
mean age of infants at the time of surfactant therapy was
7.78±0.75 h. Demographic characteristics did not differ
between two groups (Table 1). FiO2 requirement before
and one hour after surfactant replacement therapy was
not different between two groups (Table 2). Although the
mean duration of intubation and need for assisted
ventilation was significantly shorter in infants who
received curosurf, but the mean duration of
hospitalization and O2 therapy were not significantly
different between two groups. There were no significant
difference in the morality and morbidity among two
groups (Table 3). Seventy four (93.7%) patients in group A
were treated with one dose and 5 cases (6.3%) needed two
doses of curosurf. Sixty seven (94.4%) patients in group B
received one dose and 4 cases (5.6%) two doses of
survanta.
TABLE 1. Demographic Characteristics of Studied Infants
Group A
Group B
Male, n (%)
45 (57.7)
43 (64.2)
Birth weight, gr
1438.7 ± 642.82 1450.7 ± 519.01
Gestational age, wk
29.40 ± 2.90
29.50 ± 2.73
Age of treatment, h
6.89 ± 0.85
8.77 ± 1.28
Cesarean section, n (%)
48 (63.2)
50 (70.4)
P.Value
0.49
0.9
0.82
0.21
0.38
* mean ± SD
Group A= Poractant
Group B= Beractant
Maternal treatment with antenatal corticosteroids was
completed in 36 (45.5%) cases of curosurf group and 30
(42.3%) cases in survanta group.
DISCUSSION
All regimens of replacement therapy with surfactant
Indian Journal of Pediatrics, Volume 77—July, 2010

3. Complications among Premature Neonates Treated with Beractant and Poractant Alfa
TABLE 2. Primary Outcome and Treatment Requirements of Infants in the Two Groups
Group A
P.Value
72.78±20.15
40.81±15.36
89.40±17.70
94.64±2.00
9/79
3.13±1.80
2.52±1.29
24.89±26.41
17.73±22.25
FiO2 before surfactant
FiO2 after surfactant
O2 saturation before surfactant
O2 saturation after surfactant
Need for reintubation, n
Intubation duration, d
CPAP duration, d
Duration of hospitalization, d
Duration of oxygen administration, d
Group B
70.96±19.00
42.66±15.42
92.08±8.39
94.53±2.16
12/71
4.06±2.72
2.49±1.38
29.14±23.54
19.14±17.85
0.59
0.48
0.25
0.74
0.40
0.05
0.89
0.32
0.67
*mean ± SD; Group A= Poractant treated group; Group B= Beractant treated group
TABLE 3. Secondary Outcome in the Two Groups
Group A Group B
Pulmonary hemorrhage
Bronchopulmonary dysplasia
Patent ductus arteriosus
Sepsis
Air leak syndromes
Severe intra ventricular hemorrhage
Retinopathy of prematurity
Death before discharge(n)
8/79
20/79
8/79
3/79
2/79
7/79
5/79
21/79
9/71
20/71
14/71
7/71
5/71
12/71
4/71
15/71
P.value
0.79
0.71
0.11
0.19
0.25
0.14
0.57
0.45
*mean ± SD; Group A= Poractant treated group; Group B=
Beractant treated group
appear to decrease the incidence of air leaks and improve
oxygenation of ventilated preterm infants. Mortality from
RDS and even the overall mortality of ventilated preterm
infants, is significantly reduced especially when early
surfactant therapy used for these infants.1-3, 6-11 Despite
differences in chemical composition and manufacturing
methods for various natural surfactants, currently
FDAapproved formulations demonstrate comparable
clinical efficacy. Comparison of different natural
surfactants has shown modest differences in oxygenation
during the first few hrs after treatment, without
significant effect on mortality or morbidity.8-19 In the
comparison of infasurf and beactant, Clark et al did not
find significant influence on the outcome.13 Speer and co
workers compared Beractant and Poractant and
concluded that treatment with beractant associated with
reduced incidence of severe pulmonary and non
pulmonary complications. 14 In the comparison of
beractant, alveofact and poractant, Baroutis reported
fewer days of mechanical ventilation and oxygen
administration with alveofact and poractant. They had
administered beractant by pump via a side port in the
endotracheal tube adaptator.15 Malloy reported lower FiO2
requirement during first 48 hrs in patients treated by
poractant, without difference in time to extubation,
reintubation rate, intubation time or incidence of BPD in
a small number of patients.8 The present study shows that
poractant reduces the duration of intubation and need for
ventilator support in premature infants but the mean
length of admission was not shorter in these infants. The
Indian Journal of Pediatrics, Volume 77—July, 2010
apparent superiority of poractant over beractant with
respect to reduced days of intubation could be the result
from higher doses of SP-B and phospholipids used with
poractant alfa (double dose of beractant). Poractant
contains 1mg/dl of proteins including, 0.3 mg of SP-B,
whereas, beractant contains less than 1mg/dl of proteins
but exact amount of its SP-B is not quantified. The effect of
quantitative difference in SP-B on clinical outcome has not
been shown. 1, 2, 4 There are reports showing that new
synthetic peptide-containing surfactants are effective and
safe for prevention or treatment of RDS among preterm
infants and reduce the incidence of common
complications of prematurity.1 The ability to enhance the
efficacy of new synthetic surfactants is related to addition
of peptide that mimic the action of SP-B.19
BPD continues to be an important problem despite
widespread use of exogenous surfactant and strategies to
minimize the lung injury from mechanical ventilation.
This may reflect the changing pathogenesis of BPD and
the multiplicity of factors involved, among which
surfactant deficiency is only one.20,21 This is the first report
of surfactant replacement therapy in a large number of
preterm infants from authors country. The authors have
relatively little experience with natural surfactants for
treatment of RDS in premature newborn infants, but the
results are encouraging and compatible with studies
published from developed countries. One limitation of the
present study was a possibility odd enrolment bias.
CONCLUSIONS
These results show that treatment with poractant is
associated with reduced duration of intubation and
ventilatory support, but short term outcome of these
infants is not different from preterm infants treated with
beractant. Thus, there was no significant superiority of
poractant over beractant.
Acknowledgements
We are grateful for financial support of vice chancellor of Tabriz
University of Medical Sciences and assistance of Heidarzadeh M,
MD, Bargh nema R, MD, and Abedini K. Tabriz, Iran.
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4. Manizheh Mostafa Gharehbaghi et al
Contributions: MMG; act as a guarantor. SHPS and FF; did data
collection. MG; did statistical analysis.
Conflict of Interest: None.
11.
Role of Funding Source: None.
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