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Surfactant Replacement Therapy for Preterm and Term Neonates With Respiratory Distress Richard A. Polin, Waldemar A. Carlo and COMMITTEE ON FETUS AND NEWBORN Pediatrics 2014;133;156 ; originally published online December 30, 2013; DOI: 10.1542/peds.2013-3443
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PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. PEDIATRICS is owned, published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2014 by the American Academy of Pediatrics. All rights ri ghts reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.
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Guidance for the Clinician in Rendering Pediatric Care
CLINICAL REPORT
Surfactant Replacement Therapy for Preterm and Term Neonates With Respiratory Distress abstract
Richard A. Polin, MD, FAAP, Waldemar A. Carlo, MD, FAAP, and COMMITTEE ON FETUS AND NEWBORN
Respiratory failure secondary to surfactant de ciency is a major cause of morbidity and mortality in preterm infants. Surfactant therapy substantially reduces mortality and respiratory morbidity for this population. latio n. Seco Secondary ndary surfa surfactant ctant de ciency ciency also also con contri tribut butes es to acu acute te respiratory morbidity in late-preterm and term neonates with meconium aspiration syndrome, pneumonia/sepsis, and perhaps pulmonary hemorrhage; surfactant replacement may be benecial for these infants. This statement summarizes the evidence regarding indications, administration, formulations, and outcomes for surfactant-replacement therapy. The clinical strategy of intubati intubation, on, surfac surfactant tant administ administrara-
KEY WORDS surfactant, antenatal steroids, respiratory distress syndrome, meconium aspiration syndrome, neonatal pneumonia, neonatal sepsis, congenital diaphragmatic hernia, pulmonary hemorrhage, persistent pulmonary hypertension, preterm, term
tion, and extubati extubation on to continuou continuouss positiv positive e airway pressure and the effect of continuo continuous us positive airway pressure on outcomes and surfactant use in preterm infants are also reviewed. Pediatrics 2014;133:156 –163
RDS—respiratory distress syndrome RR—relative risk SP-B—surfactant protein B
INTRODUCTION Surfactan Surfac tantt re repla placem cement ent was establ establish ished ed as an effec effectiv tive e and saf safe e therapy for immaturity-relat immaturity-related ed surfactant decien ciency cy by the the ea earl rlyy 1 1990s. Systematic reviews of randomized, controlled trials con rmed that surfactant administrati administration on in preterm infants with established respiratory distress syndrome (RDS) reduces mortality, decreases the incidence incid ence of pulmo pulmonary nary air leak (pneumot (pneumothora horaces ces and pulmo pulmonary nary
ABBREVIATIONS BPD—bronchopulmonary dysplasia CI—condence interval CPAP—continuous positive airway pressure ECMO—extracorporeal membrane oxygenation INSURE—intubation, surfactant administration, and extubation LOE—level of evidence NNTB—numb number er needed needed to bene t
This document is copyrighted and is property of the American Academy of Pediatrics and its Board of Directors. All authors have led conict of interest statements with the American Academy of Pediatrics. Any con icts have been resolved through a process approved by the Board of Directors. The American Academy of Pediatrics has neither solicited nor accepted any commercia comme rciall involvement involvement in the development development of the content of this publication. The guidance in this report does not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate.
interstitial emphysema), and lowers the risk of chronic lung disease or death at 28 days of age (Table (Table 1 1). ).2–11 Subsequent trials indicated that prophylactic or early administration of surfactant resulted in fewer pneumothoraces, less pulmonary interstitial emphysema, and improved survival without bronchopulmonary dysplasia (BPD). However,, rece ever recent nt rand randomize omized d clin clinical ical trials indi indicate cate that the bene ts of prophylact proph ylactic ic surfa surfactant ctant are no longe longerr evid evident ent in grou groups ps of infan infants ts when continuous positive airway pressure (CPAP) is used routinely.5 This clini clinical cal rep report ort updates a 2008 rep report ort from the Ameri American can Acade Academy my of 1 Pediatrics. As in the previous report, a number of clinically important topics are revi reviewed ewed surro surrounding unding use of surfac surfactant, tant, inclu including ding prophylactic versus rescue replacement, preparations and administration techniques techn iques,, the synergist synergistic ic effec effects ts of surfac surfactant tant and antena antenatal tal steroids,
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and surfac surfactan tant t the thera rapy py foronrespir res pirator atoryysurfactant dis disord orders ersreplacement oth other er tha than n and RDS RDS.the . In addition, the effect of CPAP RDS and
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Copyright © 2014 by the American Academy of Pediatrics
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TABLE 1 Meta-analyses of Surfactant Replacement: Prophylaxis and Rescue Treatment With Animal-Derived and Synthetic Surfactant2,3,8,11 Outcome
Prophylactic Surfactant
Neo Neonat natal al mortali mortality ty Pneu Pneumo moth thor orax ax P IE a BPD a BPD/death
Rescue Surfactant
Animal Derived
Synthetic
Animal Derived
Synthetic
N RR (95% CI)
N RR (95% CI)
N RR (95% CI)
N R R ( 95% C I )
8 0.6 0.60 0 (0. (0.47 47–0.77 0.77)) 9 0.40 0.40 (0 (0.2 .29 9–0.54 0.54)) 6 0.46 (0.36–0.59 0.59)) 8 0.91 (0.79–1.05 1.05)) 8 0.80 (0.72–0.88 0.88))
7 6 2 4 4
0.70 0.70 0.67 0.67 0.68 0.68 1.06 1.06 0.89 0.89
(0.5 (0.58 8–0.85 0.85)) (0.5 (0.50 0–0.90 0.90)) (0.5 (0.50 0–0.93 0.93)) (0.8 (0.83 3–1.36 1.36)) (0.7 (0.77 7–1.03 1.03))
10 12 8 12 12
0.68 0.68 0.42 0.42 0.45 0.45 0.95 0.95 0.83 0.83
(0.5 (0.57 7–0.82 0.82)) (0.3 (0.34 4–0.52 0.52)) (0 (0.3 .37 7–0.55 0.55)) (0.8 (0.84 4–1.08 1.08)) (0.7 (0.77 7–0.90 0.90))
6 5 4 5 4
0. 0.73 73 0. 0.64 64 0. 0.62 62 0. 0.75 75 0. 0.73 73
(0 (0.6 .61 1–0.88) (0 (0.5 .55 5–0.76) (0 (0.5 .54 4–0.71) (0 (0.6 .61 1–0.92) (0 (0.6 .65 5–0.83)
N, number; PIE, pulmonary interstitial emphysema. a Dened at 28 d.
ef cacy of the INSURE appr approach oach (intuba (intuba- tion, tion, sur surfact factant ant adm admini inistr strati ation, on, and ex tubati tub ation on to CP CPAP) AP) are rev review iewed. ed.
PRETERM INFANTS AND SURFACTANT EFFECTIVENESS IN CLINICAL TRIALS Surfactant trials have included infants born between 23 and 34 weeks ’ ges tation and/or with birth weigh weightt be tween twee n 500 and 2000 g.1–12 The results of subgroup analyses from such studies ind indica icated ted that sur surfac factan tantt the thera rapy py decreased decr eased mortality rate ratess most effec tively in infants born at less than 30 weeks’ gestation or with birth weight 1250 0 g.12 In additi addition, on, surfactant surfactant re<125 placem placemen entt red reduce uced d the incide incidence nce of pneumothora pneumo thorax, x, pulmo pulmonary nary inter interstiti stitial al emphys emp hysema ema,, and the com combin bined ed outoutcome of death or BPD, compared with no surfac surfactan tantt rep replac laceme ement nt12; thes these e ndin ndings gs
sugg sugges estt th that at lung lung inju injury ry is miti mitigat gated ed after after surf surfact actan antt repl replac aceement. men t. The incide incidence nce of other other med medica icall morbi mor bidi diti ties es,, such such as BPD, BPD, int intra rave venn tricular tricul ar hemorr hemorrhage, hage, necr necrotizi otizing ng en terocoli tero coli tis, heal health th care –associated infections, retinopathy of prematurity, and patent ductus arteriosus, has not changed with surfactant replacement, but this may be attributable, in part, to the large reduction in mortality wit with h sur surfac factan tantt rep replac laceme ement nt the therr13 apy. The onset of clinic clinical al signs signs of paten patent t , duct ductus arteriosus susemay occu occur earlier earli er, andusthearterio inci incidenc dence of pulm pulmoo-r nary hemorrhage, especially in infants
PEDIATRICS Volume 133, Number 1, January Janu ary 2014
born at less than 27 weeks’ gestation, mayy be incr ma increa ease sed d with with surf surfac acta tant nt therapy.. Surfactant replacement is therapy effective for larger and more mature preterm infants with established RDS.
PROPHYLACTIC VERSUS RESCUE SURFACTANT A prophylactic, prophylactic, or preve preventive ntive,, surfac surfactant tant str strate ategy gy is dened as int intuba ubatio tion n and surfactant administration to infants at high high ris risk k of deve develo lopi ping ng RD RDS S fo forr th the e primary primary pur purpose pose of pre preven ventin ting g worsworsenin ening g RD RDS S rath rather er than than tr trea eatm tmen entt of est establ ablish ished ed RDS RDS;; this this has been been ope operrational ationalize ized d in cli clinic nical al stu studie diess as sursurfactant facta nt admini administra stration tion in the deli delivery very room before initial resuscitation efforts or the onset of respiratory distress or, most mo st comm commo only nly, af afte terr ini niti tial al re re-suscitation but within 10 to 30 minutes after birth. This contrasts with a rescue or treatm treatment ent sur surfac factan tantt str strate ategy gy,, in which surfactant is given only to pre term infants with establ established ished RDS. Rescue Res cue sur surfac factant tant is mos mostt often often administered minis tered within the rst 12 hours hours afterr birth afte birth,, whe when n spe speci cied thres threshold hold criteria of severity of RDS are met. The meta-analysis of studies conducted befo before re rout routin ine e appl applic icat atio ion n of CPAP CPAP demons dem onstr trate ated d a low lower er mortalit mortalityy rat rate e (relative risk [RR] 0.69; 95% con dence interval [CI] 0.56–0.85; number needed to bene t [NNTB] 20) and a decr decrease ease in the risk of air leak (RR 0.79; 95% CI 0.63–0.98) in preterm infants receiving
prophylactic surfactant prophylactic surfactant versus rescu rescue e 14 surfactant. However, when the studies thatt all tha allowe owed d for routin routine e app applic licati ation on of CPAP were included in the meta-analysis (Nation (Nat ional al Ins Instit titute ute of Chi Child ld Health Health and Human Development SUPPORT Trial and Vermont Oxford Network Delivery Room Management Trial), the bene ts of proprophylacticc surfact phylacti surfactant ant on morta mortalit lityy (RR 0.89; 95% CI 0.76–1.04) and air leak (RR 0.86; 95% CI 0.71–1.04) could no longer be demonstrated.5 Furthermore, infants receiv rec eiving ing pro prophy phylac lactic tic surfact surfactant ant had a higher incidence of BPD or death than did infants stabilized on CPAP (RR 1.12; 95% CI 1.02–1.24) 1.24).. Secon Secondary dary analyses analyses of studies that did or did not use CPAP to stabil stabilize ize inf infant antss demons demonstra trated ted a trend tre nd to a lower lower ris risk k of int intra ravent ventric ricula ularr hemorrhage (RR 0.91; 95% CI 0.82–1.00) and severe intraventricular hemorrhage (RR (RR 0.87; 0.87; 95% 95% CI 0.70 0.70–1.04) 1.04) wit with h pro pro-phylactic surfactant. That nding cannot be explai explained; ned; however, however, there was considerable heterogeneity in the trials included in the meta-analysis. The risks of developing devel oping other compli complication cationss of prematuri mat urity ty,, such such as ret retino inopath pathyy of preprematurity, patent ductus arteriosus, and periventricu perive ntricular lar leukomalaci leukomalacia, a, were not signicantly different. When studies investigating infants born at <30 weeks’ gestation were analyzed separately,5 similar ndin ndings gs were were noted. However, there was a trend for an increased risk of chronic lung disease ease in in infan fants ts born born at <30 weeks weeks’ gestat ges tation ion who rec receiv eived ed prophy prophylac lactic tic surfactant (RR 1.13; 95% CI 1.00–1.28) and a signicant increase in death or chronic lung disease (RR 1.13; 95% CI 1.02–1.25 1.25)) wi with th use use of proph prophyl ylac acti ticc surfactant.
EARLY VERSUS DELAYED SELECTIVE SURFACTANT TREATMENT OF RDS Alt Althou hough gh the there re are no sta statis tistic ticall allyy signi cant bene ts to prophylactic use of sur surfac factan tantt whe when n com compar pared ed wit with h
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prophylactic CPAP, several studies have investigated whether administration of surfactant early in the course of respiratory insuf ciency improves clinical outcomes. Early rescue is dened as surfactant treatment within 1 to 2 hours of birth, and late rescue is dened ned as surf surfac acta tant nt trea treatm tmen entt 2 or
CPAP without surfactant.15 When compare pared d wi with th the the grou group p of in infa fant ntss re re-ceivin ceiving g pro prophy phylac lactic tic sur surfac factan tantt and continued ventilation, the RR of death or BPD was 0.78 (95% CI 0.59–1.03) for the INSUR INSUREE group and 0.83 (95% CI 0.64–1. 1.09 09)) fo forr the the CPAP CPAP gr grou oup. p. How How-ever ever,, in the the nas nasal al CPAP CPAP grou group, p, 48% 48%
of surfac surfactan tantt protei protein n B (SP-B (SP-B). ). SPSP-B B enhanc enh ances es the rate of ads adsorp orptio tion n of phospholi phosp holipids pids at the air-w air-water ater int inter er-face, is involved in the formation of tubular myelin, and has antiinammatory prop propert ertie ies. s. Howe Howeve verr, it is uncl unclea earr whethe whe therr signi signica cant nt di diff ffer eren ence cess in cl clin inic ical al outc outcom omes es ex exis istt amon among g th the e
more hours after birth. A recent metaanal analys ysis is of ea earl rlyy (wit (withi hin n 2 hour hours) s) versuss dela versu delayed yed surfactant surfactant treat treatment ment concluded that the risks of mortality (RR 0.84; 95% CI 0.74–0.95), 0.95), air leak leak (R (RR R 0.61 0.61;; 95% 95% CI 0. 0.48 48–0.78 0.78), ), chron chronic ic lung lun g diseas disease e (RR 0.69 0.69;; 95% 95% CI 0.55 0.55– 0.86 0.86), ), an and d chro chroni nicc lung lung dise diseas ase e or death (RR 0.83; 95% CI 0.75–0.91) were signicantly decreased. There were no differences in other complications of prematurity. 7
were managed without intubation and 54% wit withou houtt sur surfac factan tantt tre treatme atment. nt. A recent rec ent met meta-an a-analy alysis sis dem demons onstr trate ated d that proph prophylacti ylacticc surfac surfactant tant (with rapid extubation to CPAP) was associated with a higher risk of death or BPD (RR (RR 1. 1.12 12;; 95 95% % CI 1. 1.02 02–1.24; 1.24; num number ber needed to harm of 17) when compared with early stabilization with CPAP and selective surfactant administration.5 In infants with birth weight ≥1250 g and mild to moderate RDS, elective intuba tion and admin administr istration ation of surfac surfactant tant
available animal-derived products. A synthetic surfactant (lucinactant) that contains a 21-amino acid peptide that mimics SP-B activity has recently been appr approv oved ed fo forr th the e pr prev even enti tion on and and treatme tre atment nt of RDS in prete preterm rm infan infants. ts.18,19 When comp compare ared d wit with h ani animalmal-der derive ived d surfacta surf actant nt (be (berac ractant tant or poracta poractant), nt), lucin lucinac actan tantt wa wass shown shown to be equi equivava18,19 lent. Neonata Neo natall morbidi morbiditie tiess (intra(intraventricular hemorrhage, periventricular leukomalacia, leukom alacia, pulmonary pulmonary hemorrha hemorrhage, ge, sepsis, sep sis, patent patent duc ductus tus arter arterios iosus, us, ret ret--
EARLY ADMINISTRATION OF SURFACTANT FOLLOWED BY BRIEF VENTILATION AND EXTUBATION TO CPAP (INSURE STRATEGY)
decreased the need for mechanical ven tilation but had no effect on the du tilation rat ration ion of oxygen oxygen the therap rapyy, ven ventil tilato atorr therapy ther apy,, or hospital hospital stay stay..16
inopathy of premat inopathy prematurit urityy, necrot necrotizi izing ng enterocolitis, and BPD) were not signicantly different between preterm infants infan ts treated treated with anima animal-de l-derive rived d surfactan surfa ctants ts and thos those e trea treated ted with synthetic surfactants.
The The IN INSUR SUREE st stra rate tegy gy is wi wide dely ly used used throughout throug hout the world. In rand randomized omized clinical clini cal trials performed before 2008 2008,, the INSURE approa approach, ch, compared compared with rescue res cue sur surfac factant tant admi adminis nistr trati ation on in infants with RDS, was associated with a si signi gnican cantly tly reduc reduced ed nee need d for mechanica chan icall ven ventil tilati ation on (RR 0.6 0.67; 7; 95% CI 0.57–0.79) and a reduced need for ox6
ygen at 28 days. In an analysis stratied by fr frac acti tion on of insp inspir ired ed oxyg oxygen en requir req uireme ement nt at stu study dy entry entry, a sign signiicantly higher frequency of patent duc tus arterios arteriosus us was obser observed ved among infants in the rescue surfactant group, who who requ requir ired ed a fr frac acti tion on of insp inspir ired ed oxygen greater than 0.45 (RR 2.15; 95% CI 1.09–4.23). The Vermont Oxford Network Delivery Room Management Trial (n = 648 648)) ra rando ndomly mly ass assign igned ed inf infant antss born at 26 to 29 weeks’ gestation to 1 of 3 treatm treatment ent groups: groups: pro prophy phylac lactic tic surfactant surfact ant and conti continued nued venti ventilation lation,, prophylacti proph ylacticc surfac surfactant tant and rapid ex tubation tubati on to CPAP CPAP (INSUR (INSURE), E), or nasal
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ANIMAL ANIMAL-DERIVED -DERIVED VERSUS SYNTHETIC SURFACTANT A wide wide var variet ietyy of ani animalmal-der derive ived d and synt synthe heti ticc surf surfac acta tant ntss are are av avai aila labl ble e commerciall commer ciallyy (Table 2 2); ); both are benecial as therapy for RDS in preterm infants. Animal-derived surfactants are modied or puried from bovine
SURFACTANT ANT ADMINISTRA ADMINISTRATION TION SURFACT
or por porcin cine e lun lungs. gs. Trea reatme tment nt wit with h animal-derived surfactants (beractant [Survanta; Abbvie Inc, North Chicago, IL], IL], calf calfac acta tant nt [I [Inf nfas asur urf; f; ONY ONY Inc, Inc, Amherst, NY], and poractant [Curosurf; Chiesi Farmaceutici, Parma, Italy]) has several advantages over rst-generation, protein prot ein-fre -free e synt syntheti heticc surfa surfactan ctants ts (eg,, colfos (eg colfoscer ceril il pal palmit mitate ate [Exosu [Exosurf; rf; GlaxoSmithKli GlaxoSm ithKline, ne, Middl Middlesex, esex, UK]).3 These The se includ include e low lower er mort mortali ality ty rat rates es (RR (RR 0. 0.86 86;; 95% 95% CI 0. 0.76 76–0.98 0.98;; numbe numberr need needed ed to harm harm of 40) 40) and and fe fewe werr pneu pneumo moth thor orac aces es (RR (RR 0. 0.63 63;; 95% 95% CI 0.53–0.75; 0.75; NNT NNTB B 22). 22).4 Animal-derived surfactant surfa ctantss conta contain in variab variable le amoun amounts ts
dures have dures have been been mo mode dele led d af afte terr re re-search protocols. Furthermore, repeated doses of surfactants given at intervals for predeter predetermined mined indi indicatio cations ns have decre dec rease ased d mort mortali ality ty and mor morbid bidity ity co comp mpar ared ed with with pl plac aceb ebo o or si sing ngle le 10 surfactant doses. However, given the long half-life for surfactant in preterm inf infant antss wi with th RDS RDS,,20 redo redosing sing shoul should d not be needed more often than every 12 hours, unle unless ss surfactan surfactantt is being being inactivate inact ivated d by an infectiou infectiouss process, process, meconium, or blood. Dosing intervals
Surfactant administr Surfactant administration ation strategies strategies have have been been base based d on manuf manufac actu ture rerr guidelines guide lines for indiv individual idual surfactants. surfactants.1 The dose of surfac surfactan tant, t, fre freque quency ncy of administra admini stration, tion, and treat treatment ment proce proce--
shorter 12 hours recommended by some than manufacturers are not based on human pharmacokinetic data.
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TABLE 2 Composition and Dosage of Surfactants17 Surfactant
Animal-derived a Beractant (Survanta ) minced bovine lung extract b Calfactant (Infasurf ) bovine calf lung lavage c minced d porcine porcine lung Poractant (Curosurf ) mince extract Synthetic d Colfosceril (Exosurf ) Synthetic, protein analog e Lucinactant (Surfaxin )
Main Phospholipids
Proteins
Phospholipid Concentration
Suggested Dose
Phospholipid per Dose
DPPC and PG
(<0.1%) SP-B and (1%) SP-C (0.7%) SP-B and (1%) SP-C (0.6%)SP-B and (1% ) SP- C
25 mg/mL
4 mL/kg
100 mg/kg
35 mg/mL 80 mg/mL
3 mL/kg 2.5 mL/kg and
105 mg/kg 100-200 mg/kg
1.25 mL/kg
100 mg/kg
13.5 mg/mL
5 mL/kg
67.5 mg/kg
30 mg/mL
5.8 mL/kg
175 mg/kg
DPPC and PG DPPC and PG
DPPC (100%)
None
DPPC and POPG
KL4 peptide as SP-B
DPPC, dipalmitoyl phosphatidylcholine; PG, phosphatidylglycerol; POPG, palmitoyloleyl phosphatidylglycerol; SP-C, surfactant protein C. a Abbvie Inc, North Chicago, IL. b ONY Inc, Amherst, NY. c Chiesi Farmaceutici, Parma, Italy. d GlaxoSmithKline, Middlesex, UK. e Discovery Laboratories, Warrington, PA.
Surfactant administration procedures may be complicated by transient airway obstruction, oxygen desaturation, bradycard brad ycardia, ia, and alter alteration ationss in cere cere--
endotracheal tube occurred more of ten when the infusion technique was used. Similar clinical outcomes were als also o found found whe when n sur surfac factan tantt was ad-
bral blood ow and brain brain electr electrica icall activity. The delivery of surfactant can also also res result ult in rapid rapid imp improv roveme ement nt in lung volume, func functiona tionall resi residual dual capacityy, and compliance pacit compliance.. Thus Thus,, expe expedidi tious changes in mechanical ventilator settings may be necessary to minimize the risks of lung injury and air leak. Cl Clin inic icia ians ns with with ex expe perti rtise se in thes these e procedures should be responsible for surfactant surfa ctant admin administr istration ation when whenever ever surfactant is given.
ministered as a bolus or as a 1-minute infusion through a side-hole adapter.24 Because data are conicting and limited, the optimal method of surfactant administration in preterm infants has yet to be clearly proven. Additionally, there is insuf cien cientt evide evidence nce to recommend the optimal number of frac tional doses of surfactant or what body position is best when surfactant is administered.
Surfac Sur factant tant has tradit tradition ionall allyy bee been n ad-
A num number ber of alterna alternative tivess to int intrat ratrac rachea heall administration of surfactant have been
minister minist ered ed thr throug ough h an endotr endotrach acheal eal tube tub e ei eith ther er as bo bolu lus, s, in ssmal malle lerr aliqu aliquots ots,,21 or by infu infusi sion on thro throug ugh h an adap adapto torr port on the proximal end of the endotracheal tube.19 In an animal model, administration of surfactant as an in tratracheal bolus while disconnected from from the mec mechan hanica icall ven ventil tilato atorr reresul sulted ted in mor more e uni unifor form m distri distribut bution ion than an infusion administered over 30 minutes through a side-hole adapter.22 However, a small clinical trial of human preter pre term m infant infantss sho showe wed d no signi signi-
evaluated evaluate d in clinic clinical al tria trials. ls.25–32 These includ include e use of aer aerosol osolize ized d surf surfacta actant nt prepar pre parati ations, ons, lary larynge ngeal al mas mask k airw airwayayaided delivery of surfactant, instillation of pharyngeal surfactant, and adminis tration tra tion of surf surfacta actant nt usi using ng thi thin n intraintra trache tra cheal al cath cathete eters. rs. The Theore oretic tically ally,, eac each h of these methods could allow adminis tration tra tion of surf surfact actant ant wit withou houtt int intubat ubation ion in spontan spontaneou eously sly bre breathi athing ng infa infants. nts. In a recent study, Göpel et al25 randomized 220 220 pret preter erm m infan infants ts bo born rn at 26 to 28 weeks’ gestation to receive either sur-
cant diffe differenc es in 23clin clinical ical outco outcomes mes betwee between n rences methods. During surfac tant admin administrat istrat ion, re ux into the
fact factant ant admi adminis nister tered ed via a thi thin n surfacplastic plastic catheter (using laryngoscopy) or tantt administered as a rescue therapy tan therapy..
PEDIATRICS Volume 133, Number 1, January Janu ary 2014
All infants were maintained on CPAP. The The admi admini nist stra rati tion on of surf surfac acta tant nt through a thin plastic catheter signican cantly tly re reduc duced ed the need for mechanic cha nical al ventil ventilati ation on and dec decre rease ased d the need for oxygen therapy at 28 days. day s. Mor More e dat data a are need needed ed to re reccommend ommen d any of the alternative alternative techniques for surfactant administration.
SURFACTANT REPLACEMENT THERAPY FOR RESPIRATORY DISORDERS OTHER THAN RDS Surfactant Surfacta nt inac inactiva tivation tion and sec seconda ondary ry dysfunction may occur with conditions such as meco meconiu nium m aspi aspirat ration ion syndro syndrome, me, persist pers istent ent pul pulmona monary ry hype hypertens rtension ion of the new newborn born,, neon neonatal atal pneumo pneumonia, nia, and pulmonaryy hemorrhag pulmonar hemorrhage. e.33,34 Surfactant administration administ ration techniques, techniques, surfactan surfactantt dosage, dosa ge, pat patien ientt pop populat ulations ions,, ent entry ry cri teria, teri a, and stud studyy outcome outcomess in the small small randomi ran domized zed trials and case serie seriess of surfac sur factan tantt re repl plac acem emen entt in ne neon onate atess wi with th secon secondar daryy surfac surfactan tantt deciency – 35 42 vary considerably. Meconium aspir Meconium aspiration ation syndr syndrome ome with severe sever e respirator respiratoryy failure failure and persi persiss tent pulmo pulmonary nary hyperte hypertension nsion may be complicated by surfactant inactivation. Surfac Sur factant tant replac replaceme ement nt by bol bolus us or slo slow w inf infusi usion on in inf infant antss wit with h severe severe
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meconium meconi um asp aspir irati ation on syn syndro drome me improved pro ved oxyg oxygen enati ation on and red reduce uced d the need nee d for ext extrac racorp orpore oreal al membr membrane ane oxygena oxyg enatio tion n (ECM (ECMO) O) (RR 0.6 0.64; 4; 95% CI 35 0.46–0.91; NNTB 6). Surfac Surfactant tant did not reduce mortality or decrease the frequency of air leaks (pneumothorac (pneumothoraces es or pulmonary pulmonary inte interstiti rstitial al emphy emphysema). sema). In a blind blinded ed randomiz randomized ed clinical trial of infants receiving ECMO, administration of surfactant shortened the duration of the ECMO ECMO.. Notabl Notablyy, there were no infantss with conge infant congenital nital diaph diaphragma ragmatic tic 36 hernia in that study. Surfactant inac Surfactant inactivat tivation ion may be associated with pneumonia.37,38 In a small randomized trial of surfactant rescue therapy,, the subgroup of infants with therapy sepsis showed improved oxygenation and a reduc reduced ed need for ECM ECMO O com com-pared with a similar group of control
outcomes. In fact, the need for ECMO, the incidence of chronic lung disease, and mort mortali ality ty rate rate wer were e inc increa rease sed d 41,42 with surfactant administration.
ANTENATAL STEROIDS AND SURFACTANT REPLACEMENT Surfactant trials that prov Surfactant proved ed ef cacy were performed at a time when an tenatal steroid therapy was given infrequently.43 By the late 199 1990s, 0s, most mother mot herss of pre prete term rm infant infantss bor born n at less than 30 weeks’ gestation had receiv ceived ed ante antena nata tall ster steroi oids ds (58% (58% to 44 – 46 92%). Antenatal Anten atal ster steroids oids signicantly reduce mortality (RR 0.62; 95% CI 0.51–0.77; NNTB 23), RDS (RR 0.65; 95% CI 0.47–0.75; NNTB 12), and surfa fact ctan antt use use in pret preter erm m infa infant ntss (RR (RR 0.45; 95% CI 0.22–0.93; NNTB 9),47 most consistently in those born between 28
exposed to antenatal steroids at 23 to 25 week weekss’ gestation.49 Infants born before 32 weeks’ gestation who received both antenat antenatal al steroi steroids ds and pos postna tnatal tal surfa surfact ctant ant we were re found found on subg subgro roup up analyses to have signicant reductions in mortality, severity of respiratory dis tress, tre ss, and air lea leaks ks when when comp compare ared d wit with h subgrou subgroups ps that rec receiv eived ed nei neithe therr steroi steroids ds nor sur surfact factant ant,, ante antenata natall steste– 50 52 roids only, or surfact surfactant ant only only.. This nding corroborates evidence from animal models of RDS that the combina tion of antena antenatal tal stero steroids ids and post postnat natal al surfactant improves lung function more than either either tre treatm atment ent alo alone. ne.53–55 An important additional bene t of an tenatall steroids tenata steroids is a reduction reduction in risk of intra intraventr ventricula icularr hemorrhage, hemorrhage, an advantage not found with surfactant replacemen repla cementt alone alone..56 The eff effect ectss of
37
infants. Newborn infants with pneumonia or sepsis receiving rescue surfac tant also demonstrated improved gas exch exchan ange ge comp compar ared ed with with infa infant ntss with withou outt surf surfac acta tant nt trea treatm tmen ent. t. The The numb number er of neon neonat ates es wh who o rece receiv ived ed surfactant for sepsis and pneumonia in these clinical reports is small, and no recommendation can be made. Surfa Surfacta ctant nt trea treatm tmen entt of pulm pulmon onary ary hemorrhage is plausible, because blood inhibi inhibits ts sur surfact factant ant functi function. on. How Howeve everr, only a few retros retrospec pective tive and obs observa erva- tional rep tional reports orts hav have e doc docume umente nted d the bene ts of suc such h the therap rapyy, and the mag mag-nit nitude ude of ben bene e t rem remain ainss to be est estabab39 lished. Congenital diaphragmatic hernia may be as asso soci ciat ated ed with with su surf rfac acta tant nt ininsuf ciency.40 Although measurements of disatu disaturat rated ed phosph phosphati atidyl dylcho cholin line e from lungs of infants with congenital diaphragmatic hernia show synthetic rat rates es sim simila ilarr to tho those se from from infant infantss withou withoutt dia diaphr phragm agmati aticc herni hernia, a, poo pooll sizes and kinetics are altered.40 However, surfactant treatment of a large series ser ies of infant infantss wi with th con congen genita itall diaphragmat aphr agmatic ic herni hernia a did not impr improve ove
160
and 34 weeks’ gestation. Result Res ultss of obs observ ervati ationa onall stu studie diess and clinical clini cal trial trialss have inferred that antenatal steroids may reduce the need for prophylact proph ylactic ic and early rescue surfac tant repla replacemen cementt in infant infantss born after 27 to 28 weeks’ gestation,16,48 but no rand random omiz ized ed,, cont contro roll lled ed tr tria ials ls ha have ve addressed this issue. In infants born at or earlier than 27 weeks’ gestation, the incidence of RDS is not reduced after exposu exp osure re to ante antenata natall ste steroi roids; ds; how how-everr, in a rec eve recent ently ly pub publis lished hed stu study dy,,
antenatal steroids on other neonatal morbiditie morbi dities, s, such as necrotizi necrotizing ng en terocolitis and patent ductus arteriosus, have been inconsistent. However, antena ant enatal tal ste steroi roids ds have have not signi signica cant ntly ly decr decrea ease sed d th the e in inci cide denc nce e of BPD.50,51
death dea th or neu neurod rodeve evelopm lopment ent imp impair air-ment at 18 to 22 months was signicantly lower for infants who had been
report from the American Academy of Pediatrics, “Res Respir pirato atory ry Support Support of the Preterm Infant,” is forthcoming.57
CPAP AND SURFACTANT Randomized clinical trials suggest that nasal CPAP is acceptable as an alternative to surfactant administration in preter pre term m inf infant antss wi with th RDS RDS.. A cli clinic nical al
TABLE 3 Levels of Evidence 59 Recommendation LOE
LOE
Grade of Recommendation
Preterm infants born at <30 wk of gestation who need mechanical mecha nical ventilat ventilation ion because of severe severe RDS should be given surfactant after initial stabilization. Using CPAP immediately after birth with subsequent selective surfactant administration should be considered as an alternative altern ative to routin routine e intubation intubation with prophylac prophylactic tic or early surfactant administration in preterm infants. Rescue surfactant may be considered for infants with hypoxic
1
Stro Strong ng Re Reco comm mmen enda dati tion on
1
Stro Strong ng Re Reco comm mmen enda dati tion on
2
Recommenda ttiion
respiratory failure attributable to secondary surfactant deciency (eg, meconium aspiration syndrome or sepsis/ pneumonia).
FROM THE A AMERIC MERICAN AN ACADEMY ACADEMY OF P PEEDIATRICS
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FROM THE AMERICAN ACADEMY OF PEDIATRICS
SUMMARY OF SCIENCE 1. Sur Surfac factan tantt rep repla lacem cement ent,, given given as prophylax prop hylaxis is or resc rescue ue treatment, treatment, reduces the incidence of RDS, air leak leaks, s, an and d morta mortali lity ty in pret preter erm m infants with RDS (level of evidence [LOE] 1).
hernia doe hernia doess not imp improv rove e cli clinic nical al outcomes (LOE 2). 8. Ant Anten enata atall ste steroi roids ds and pos postna tnatal tal surfactant surfa ctant repl replacem acement ent inde indepenpendentlyy and addi dentl additivel tivelyy reduce reduce mor tality,, the severity of RDS, and air tality leaks in preterm infants (LOE 2).
or unc uncomf omfortab ortable le wit with h surfac surfactant tant administr admin istration ation or managi managing ng an infantt who has rec fan receiv eived ed surfac surfactant tant should wait for the transport team to arrive. arrive. LEAD AUTHORS Richard A. Polin, MD, FAAP
2. Bot Both h an anim imal al-d -der eriv ived ed and and newe newerr synth syntheti eticc sur surfac factan tants ts wit with h SPSP-B B– like activity decr decrease ease acute respiratory rato ry morbi morbidity dity and mortali mortality ty in preterm infants with RDS (LOE 1). 3. Early rescue surfact surfactant ant treatmen treatmentt (<2 hours of age) in infants with RDS decreases the risk of mortality, air leak, and chronic lung disease in preterm infants (LOE 1). 4. Ear Early ly initiati initiation on of CPAP CPAP with sub subse se-quent selective surfactant adminis tration trat ion in extr extremely emely preter preterm m infant infantss results in lower rates of BPD/death when when co comp mpar ared ed wi with th trea treatm tmen entt with proph prophylacti ylacticc surfac surfactant tant therapy (LOE 1). 5. Surf Surfac acta tant nt re repl plac acem emen entt has has not not been shown to affect the incidence of neur neurologi ologic, c, deve developme lopmental, ntal, behavioral havi oral,, medic medical, al, or educ education ational al outcomes in preterm infants (LOE 2). 6. Surfac Surfactant tant treatm treatment ent improve improvess oxygenation and reduces the need for ECMO without an increase in mor-
CLINICAL IMPLICATIONS (TABLE 3) (TABLE 3)
Waldemar A. Carlo, MD, FAAP
1. Pre Preter term m infan infants ts born at <30 weeks’ gestation who need mechanical ven tilati tilation on bec becaus ause e of seve severe re RDS sshou hould ld be given surfactant after initial stabilization (Strong Recommendation).
COMMITTEE ON FETUS AND NEWBORN, 2012 2013
2. Using CP CPAP AP immedi immediately ately afte afterr birth with subseq subsequent uent select selective ive surfactant surfactant administration should be considered as an alterna alternative tive to rout routine ine intubaintuba tion with with pro prophyl phylact actic ic or ear early ly surfactant fact ant adm admini inistr stratio ation n in preter preterm m infants (Strong Recommendation). 3. Resc Rescue ue surfa surfactant ctant may be co cons nsid id-ered for infants with hypoxic respira tory failur failure e attri attribut butabl able e to sec second ondary ary surfactant deciency (eg, pulmonary hemorrhage, meconium aspiration syndrome synd rome,, or seps sepsis/pn is/pneumon eumonia) ia) (Recommendation). 4. Pre Preter term m and term term neo neonat nates es who are recei receivin ving g sur surfac factan tantt should should be managed by nursery and transport pers personnel onnel with the tech technical nical and clinical expertise to administer
–
Lu-Ann Papile, MD, FAAP, Chairperson Richard A. Polin, MD, FAAP Waldemar A. Carlo, MD, FAAP Rosemarie Tan, MD, FAAP Praveen Kumar, MD, FAAP William Willi am Benitz, Benitz, MD, FAAP Eric Eichenwald, MD, FAAP James Cummings, MD, FAAP Jill Baley, MD, FAAP
CONSULTANT Roger F. Soll, MD, FAAP
LIAISONS Tonse N. K. Raju, MD, FAAP – National Institutes of Health CAPT Wanda Denise Bareld, MD, FAAP – Centers for Disease Control and Prevention National Ass Associ ociatio ation n of Erin Erin Keels, Keels, MSN – National Neonatal Nurses Anne Jefferies, MD – Canadian Pediatric Society Section on Kaspe Kasperr S. Wa Wang, ng, MD MD,, FAA FAAP P – AAP Section Surgery American College College of George Geor ge Macones, Macones, MD – American Obstetricians Obstetr icians and Gynecologist Gynecologists s
STAFF Jim Couto, MA
surf surfac acta tant nt safe safely ly and and deal deal with with multisystem illness. Therefore, pediatric providers who are without expertise, perti se, or who are ine inexpe xperie rience nced d
Dr Carlo is on the Mednax Board of Directors. Dr Polin is a consultant for Discovery Labora tories.
1. Engle WA; American Academy Academy of Pediatrics
3. Seger Seger N, Soll R. Animal Animal derived surfa surfactan ctantt
5. Rojas-Re Rojas-Reyes yes MX MX,, Morley Morley CJ, CJ, Soll Soll R. ProPro-
Committee on Fetus and Newborn. Surfactant-
extract extr act for treatme treatment nt of respirat respiratory ory dis-
phylactic versus selective use of surfactant
replacem repl acement ent therapy therapy for resp respira iratory tory dis-
tress syndrome. syndrome. Cochrane Database Syst
in prevent preventing ing morbidity morbidity and mortality mortality in
tress in the preterm and term neonate.
Rev . 2009; (2):CD007836
Cochrane Databas Database e Syst preterm infants. Cochrane
bidity in neo bidity neonat nates es with with mec meconiu onium m aspiration syndrome (LOE 2). 7. Sur Surfa fact ctan antt trea treatm tmen entt of infa infant ntss with conge congenita nitall diap diaphrag hragmati maticc
DISCLOSURES
REFERENCES
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PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. PEDIATRICS is owned, published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2014 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.
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Surfactant Replacement Therapy for Preterm and Term Neonates With Respiratory Distress Richard A. Polin, Waldemar A. Carlo and COMMITTEE ON FETUS AND NEWBORN Pediatrics 2014;133;156 ; originally published online December 30, 2013; DOI: 10.1542/peds.2013-3443
PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. PEDIATRICS is owned, published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2014 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.
Downloaded from from pediatrics.aappublications.org at Indonesia:AAP Sponsored on November 2, 2014
