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Original Article
1
Neurodevelopmental Outcomes of Very Low Birth Weight Preterm Infants Treated With Poractant Alfa versus Beractant for Respiratory Distress Syndrome Zeynep Eras, MD1 Evrim Alyamac Dizdar, MD1 Gozde Kanmaz, MD1 Nilufer Guzoglu, MD1 Hatice Tatar Aksoy, MD1 Gokce Baykal Altunkaya1Q1 Fuat Emre Canpolat, MD1 Ugur Dilmen, MD1,2 Q2
1 Department of Neonatology Q2, Zekai Tahir Burak Maternity Teaching
Hospital, Ankara, Turkey 2 Department of Pediatrics, Yıldırım Beyazıt University, Ankara, Turkey
Address for correspondence Zeynep Eras, MD, Department of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, 06230, Cebeci, Ankara, Turkey (e-mail:
[email protected]).
Am J Perinatol 2013;00:1–6.
Abstract
Keywords
► respiratory distress syndrome ► poractant alfa ► beractant ► neurodevelopmental outcome
Background Some controlled trials have shown significant differences in short-term clinical outcomes between poractant alfa and beractant in infants with respiratory distress syndrome (RDS). There is, however, no study showing the differences in longterm outcomes with these treatments. Aim To determine and compare the neurodevelopmental outcomes of preterm infants with RDS treated with poractant alfa or beractant at 2 years of age. Methods This was a prospective, longitudinal, single-center cohort study of infants born at 1,500 g and/or 32 weeks between 2008 and 2009 who received either poractant alfa (n ¼ 113) or beractant (n ¼ 102) for RDS. Neurological and developmental assessments were performed at a corrected age of 18 to 24 months. Results About 33 of 113 infants (29.2%) in the poractant alfa group had neurodevelopmental impairment compared with 36 of 102 (35.2%) in the beractant group, and the results did not differ between the groups (p ¼ 0.339). Similarly, no significant difference was found in the percentage of infants with cerebral palsy (11.5 vs. 16.7%, respectively; p ¼ 0.275). Conclusion Our findings suggest that poractant alfa and beractant are similar in terms of neurodevelopmental outcomes when used for the treatment of RDS in preterm infants.
Advances in antenatal and neonatal care of very preterm infants have increased the survival rates of these high-risk infants. With these improvements, there is also increased recognition of long-term outcomes including motor, cognitive, communicative, and behavioral disorders.1,2 Respiratory distress syndrome (RDS) secondary to surfactant deficiency is a major cause of morbidity in preterm infants. It occurs in nearly 50% of preterm infants born
at < 30 weeks of gestation.3 Surfactant therapy became available in the 1980s and has become the standard care for infants with or at risk for RDS.4 Although two classes of surfactant products are currently available (i.e., natural and nonprotein-containing synthetic surfactants), natural modified surfactants derived of bovine or porcine origin seem to be more effective in improving clinical outcomes.5–7
received March 19, 2013 accepted after revision June 11, 2013
Copyright © 2013 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-0033-1351659. ISSN 0735-1631.
Q1
2
Neurodevelopmental Outcomes of Poractant Alfa vs. Beractant Beractant, calfactant, and poractant alfa are the three most commonly used natural surfactants worldwide. Prospective randomized trials as well as large retrospective studies have shown significant differences in short-term outcomes and cost among these surfactants.4,7–9 Treatment with poractant alfa is associated with lower mortality10,11 and significant cost benefits12,13 compared with beractant. Similarly, Dizdar et al reported that treatment with poractant alfa decreases redosing, enables rapid extubation, and decreases the risk of bronchopulmonary dysplasia (BPD) compared with beractant in preterm infants.14 To our knowledge, no study has shown the differences in long-term neurodevelopmental outcomes between these two surfactant preparations. Therefore, we assessed the effects of these two treatment regimens on neurodevelopmental outcomes at 2 years of age. Because treatment with poractant alfa is associated with decreased mortality and BPD rates, we hypothesized that it would provide better long-term neurodevelopmental outcomes compared with beractant in preterm infants with RDS.
Materials and Methods Study Population
Q3
This prospective, single-center cohort study was conducted in the neonatal intensive care unit (NICU) of Zekai Tahir Burak Maternity Teaching Hospital. Inborn preterm infants born at a gestational age of 32 weeks between January 2008 and January 2009 who suffered from RDS were enrolled in the study. Q3Infants with major congenital anomalies and those with no parental consent were excluded from the study. RDS was diagnosed in infants exhibiting the following symptoms: a need for supplemental oxygen, tachypnea, grunting, and intercostal retractions. RDS was confirmed by typical X-ray (uniform reticulogranular pattern accompanied by peripheral air bronchograms) and blood gas findings (pH 7.25 and PCO2 55 mm/Hg). Patients with signs of RDS who were under respiratory support and required a fraction of inspired oxygen (FIO2) of 0.4 in the first 2 hour of life to maintain SpO2 levels between 85 and 92% were randomized to receive either poractant alfa or beractant. Sequentially numbered sealed opaque envelopes stratified by gestational age were used for randomization. Infants who demonstrated effort of spontaneous breathing were supported with nasal continuous positive airway pressure and underwent early rescue surfactant treatment if indicated. Infants who initially required intubation and mechanical ventilation were promptly extubated after surfactant administration. Infants who survived to a corrected age (CA) of 18 to 24 months were invited to participate in the second arm of the study, which was conducted between January 2010 and January 2012. The Bayley Scales of Infant Development II (BSID II) was used for developmental assessment; vision, hearing, and neuromotor status were also evaluated. The trial was approved by the local ethics committee, and written informed parental consent was obtained for each patient. The investigators who performed the BSID II were blinded to the surfactant treatment groups. American Journal of Perinatology
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The developmental assessment was performed using BSID II for subjects up to 42 months of age.14 The mental developmental index (MDI) and psychomotor developmental index (PDI) were also determined. A score of 49 was assigned in cases where the child was unable to complete the developmental tests. Perinatal characteristics were extracted from the NICU database by the researchers.
Definition of Outcome Variables The outcome of the study was neurodevelopmental impairment (NDI), which was defined as the presence of one or more of the following events: (1) cerebral palsy (CP) with functional deficits, (2) bilateral hearing loss and/or blindness, and (3) MDI or PDI of < 70 on the BSID II. CP was defined as a nonprogressive motor disorder with abnormal muscle tone, persistent or exaggerated primitive reflexes, or a positive Babinski sign associated with delayed motor development.15
Statistical Analysis Descriptive analyses of the demographic and clinical characteristics of the patients were performed. Student’s t-test or the Mann-Whitney U test was used for comparison of numeric variables between the two groups. The chi-square test was used for comparison of ratios between the two groups. Binary logistic regression analysis was used to conduct multivariate analysis of factors associated with neurodevelopmental outcome. Statistical analysis was performed using the SPSS software version 17.0 (SPSS Inc., Chicago, IL), and statistical significance was set at p < 0.05.
Results A total of 128 out of 135 infants in the poractant alfa group and 115 of 125 infants in the beractant group survived until 18 to 24 months CA and were included in the study sample. A total of 28 infants (15 in the poractant alfa group and 13 in the beractant group) were lost to follow-up (the parents of 18 refused to participate, 6 moved to another city, and 2 died after discharge). Complete assessment data were available for 113 (88.3%) infants in the poractant alfa group and 102 (88.7%) infants in the beractant group. The baseline demographic characteristics of the study population are shown in ►Table 1. The mean birth weights (1,118 270 vs. 1,140 313 g) and gestational ages (28.5 2.3 vs. 28.4 2.2 wk) were similar between the poractant alfa and beractant groups, as were the female/ male ratios. There were no significant differences between the two groups in the perinatal variables, with the exception of the rate of low Apgar scores, which was lower in the poractant alfa group than in the beractant group (p ¼ 0.015).
Neurodevelopmental Outcomes Neurodevelopmental outcome variables are shown in ►Table 2. The median age at assessment was 21.1 2.5 months CA in the poractant alfa group and 20.7 2.4 months CA in the beractant group. There was no significant difference in the median age at assessment between the two groups (p ¼ 0.309).
Neurodevelopmental Outcomes of Poractant Alfa vs. Beractant Table 1
Q4
Eras et al.
Baseline characteristics of the infants in the follow-up cohort
Q4
Variables
Poractant alfa (n ¼ 113) N (%)
Beractant (n ¼ 102) N (%)
p
Birth weight (mean SD, g)
1118 270
1140 313
0.586
Gestational age (mean SD, wk)
28.5 2.3
28.4 2.2
0.874
Male sex number (%)
49 (43)
55 (54)
0.122
Low Apgar score (5 min < 5)
27 (23.9)
40 (39.2)
0.015
Patent ductus arteriosus
37 (32.7)
40 (39.2)
0.323
10 (8.8)
13 (12.7)
0.356
Severe intraventricular hemorrhage
a
Necrotizing enterocolitis of stage 2 or higher
b
3
17 (15)
11 (10.8)
0.354
Sepsis (proven/clinical)
74 (65)
61 (60)
0.389
Bronchopulmonary dysplasia
24 (21.2)
28 (27.5)
0.288
Abbreviations: min, minute; SD, standard deviation; wk, weeks. a Severe was defined as grade 3 or 4 intraventricular hemorrhage using the criteria of Papile.16 b Stages 2 and 3 necrotizing enterocolitis were defined according to the Modified Bell Staging Criteria.17
Table 2 Neurodevelopmental outcomes of the cohort at 18 to 24 months Corrected Age Variables
Poractant alfa (n ¼ 113) N (%)
Beractant (n ¼ 102) N (%)
p
Age at assessment (mo)
21.1 2.5
20.7 2.4
0.309
33 (29.2)
36 (35.2)
0.339
MDI
86.8 17.2
85.9 18.7
0.716
PDI
84.6 20.1
81.2 20.1
0.222
MDI < 70
16 (14)
21 (20.6)
0.216
PDI < 70
26 (23)
25 (24.5)
0.796
NDI
a
CP
13 (11.5)
17 (16.7)
0.275
Bilateral deafness
1 (0.8)
2 (1.8)
0.606
Bilateral blindness
0
0
–
Abbreviations: CP, cerebral palsy; MDI, mental developmental index; Mo, months; NDI, neurodevelopmental impairment; PDI, psychomotor developmental index. a NDI was defined as one or more of the following at 18 to 24 months CA: (1) moderate-to-severe CP with functional deficits, (2) bilateral hearing loss and blindness, or (3) an MDI or PDI < 70 on the BSID II.
Infants treated with poractant alfa had a risk of NDI similar to that of infants treated with beractant (►Table 2). However, in both groups, the proportion of infants with NDI was substantial. The mean MDI and PDI were similar (p ¼ 0.716 and p ¼ 0.222). There was no significant difference in the percentage of infants with a PDI < 70 (p ¼ 0.796). Although the percentage of infants with indices under 70 (14 vs. 20.6%) was lower in the poractant alfa group than in the beractant group, the difference was not significant (p ¼ 0.212). Similarly, the percentage of infants with CP was lower in the poractant alfa group than in the beractant group, but the difference was not significant (p ¼ 0.275).
In univariate analysis, gestational age, Apgar scores, and the presence of BPD, retinopathy of prematurity, NECQ5, sepsis, severe intraventricular hemorrhage (IVH), and patent ductus arteriosus were associated with NDI development. In multivariate analysis, only BPD (odds ratio [OR], 1.821; 95% confidence interval [CI], 0.944–3.515; p ¼ 0.074) and IVH (OR, 3.176; 95% CI, 1.306–7.724; p ¼ 0.011) were associated with a higher risk of NDI.
Discussion In this study, we found a similar rate of impairment for each component of the neurodevelopmental assessment in infants American Journal of Perinatology
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Q5
4
Q6
Neurodevelopmental Outcomes of Poractant Alfa vs. Beractant treated with poractant alfa compared with those receiving beractant. Surfactant therapy that improves pulmonary functions and reduces mortality is a life-saving treatment for preterm infants with RDS. Several randomized trials compared various animal-derived surfactants for prevention and treatment of RDS. Treatment with poractant alfa was associated with lower mortality, redosing, risk of BPD, and cost compared with beractant.4,10–13,18,19 To our knowledge, previous poractant alfa and beractant comparison trials have not reported long-term outcomes beyond the neonatal period. This may limit the ability to draw conclusions related to the impact of poractant alfa on long-term morbidity after discharge from the NICU. We found some trials that compared the neurodevelopmental outcomes of various surfactant preparations or surfactant versus placebo. Published follow-up data from studies that compared various surfactants with placebo demonstrate that the improved survival secondary to surfactant treatment is not associated with subsequent increased morbidity.20,21 Moya et al reportedQ6 no major differences in neurologic outcomes at 1 year CA between infants who received lucinactant and those who received animal-derived surfactants (poractant alfa or beractant).22 A study that assessed the outcome of surviving babies enrolled in the first European multicenter trial of porcine surfactant (Curosurf) replacement concluded that surfactant treatment for severe RDS is not associated with an increase in disability 2 years later.23 Notably, this is the first study to date that has compared the long-term outcomes of poractant alfa and beractant. The overall NDI at 18 to 24 months CA was similar in both groups. A remarkable finding is that the percentages of infants with indices < 70 (14 vs. 20.6%) and CP (11.5 vs. 16.7%) were lower in the poractant alfa group than in the beractant group, although the difference was not significant (p ¼ 0.212 and p ¼ 0.275). Because a low Apgar score is known to be associated with a poor outcome, we suggest that this finding may be due to the higher number of infants with low Apgar scores in the beractant group. Studies have demonstrated that children with low Apgar scores and subsequent signs of cerebral depression who do not develop CP may still have an increased risk of developing a variety of NDIs and learning difficulties.24,25 Low Apgar scores, severe IVH, BPD, NEC, proven sepsis, patent ductus arteriosus, and a need for mechanical ventilation for more than 5 days have been reported to be major causes of adverse outcomes in preterm neonates. These adverse outcomes include increased rates of CP and other neurosensory and motor abnormalities as well as poor cognitive outcomes during early childhood and school age.26–31 Similarly, in our study, BPD and IVH were found to be associated with a higher risk of NDI. The rates of severe IVH and BPD were similar in the poractant alfa and beractant groups. Although the study showed no difference in rates of NDI between the groups this could be a type II error due to study design. American Journal of Perinatology
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Conclusion The findings of this first 2-year follow-up study suggest that administration of poractant alfa to infants with RDS results in neurodevelopmental morbidity similar to that in infants administered beractant. Recent findings suggest better outcomes in the neonatal period for poractant alfa versus beractant; these data complement our findings regarding the longterm safety of poractant alfa for the treatment of RDS.
Note There are no previous publications or submissions with any overlapping information, including studies and patients. A statement that the article will not be submitted to any other journal while it is under consideration by American Journal of Perinatology. Dr. Zeynep Eras had primary responsibility for protocol development, patient screening, enrollment, outcome assessment, preliminary data analysis, and writing the article. Drs. Evrim Dizdar, Gözde Kanmaz, and Nilufer Guzoglu participated in the development of the protocol and analytical framework for the study and contributed to the writing of the article. Dr. Hatice Tatar Aksoy and child development specialist Gokce Baykal Altunkaya were responsible for patient screening. Dr. Fuat Emre Canpolat and Dr. Ugur Dilmen supervised the design and execution of the study, performed the final data analyses, and contributed to the writing of the article. A statement that each author listed on the article has seen and approved the submission of this version of the article and takes full responsibility for it. We have no conflict of interest. No financial support was taken for this study.
Conflict of Interest The authors report no conflict of interest. No financial support for this study was received.
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Author Query Form (AJP/13m0084) Special Instructions: Author please write responses to queries directly on proofs and then return back. Q1: AU: Please provide the degrees of Gokce B. Altunkaya and check the author names with the respective affiliations for accuracy. Q2: AU: Please check the affiliations for correctness. Q3: AU: Please check rewording of sentence beginning with Inborn preterm infants born at. Q4: AU: Please check the table for accuracy. Q5: Au: Please define NEC at its first occurrence. Q6: AU: The author given here do not match with that given in the reference list please check. Also, note that the references have to be cited in a sequential order. Q7: AU: Please check Ref. 15 for accuracy. Q8: AU: Ref. 19 has been updated as per PubMed please check.
