Journal Club Surfactant (2)

7/25/2019 Journal Club Surfactant (2)

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Journal Club-ANIRUDHA GARDE


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Surfactant Administration via Thin Catheter During

Spontaneous Breathing : Randomized Controlled TrialH. Gozde Kanmaz, MD, Omer Erdeve, MD,

F. Emre Canpolat, MD, Banu Mutlu, MD, and Ugur Dilmen,

MD,

Division o !eonatolog", #e$ai %a&ir Bura$ Maternit" %ea'&ing Hospital, and Division o!eonatolog", (n$ara Universit" )'&ool o Medi'ine, (n$ara, %ur$e"* and Department o

+ediatri's, -ld-r-m Be"az-t Universit" )'&ool o Medi'ine, (n$ara, %ur$e"

+O) O!E !ov /012*34115*e66333


3/53

Introduction +atent du'tus arteriosus 4+D(5 in preterm inants is 'ommon, 7it&

an in'iden'e rate as &ig& as 208 in ver" lo7 9irt& 7eig&t inants. :1; +ersistent +D( in preterm inants 'an lead to serious 'lini'al

'onse


4/53

&en drug treatment ails, 'lini'ians ma" resort to surgi'al

intervention o s"mptomati' +D( in preterm inants and t&e ris$ o

'ompli'ations rom t&e operation is &ig&. :1/,12; %&ereore, a saeand ee'tive alternative drug or t&e treatment o +D( is urgentl"

needed.

e'ent studies &ave s&o7n t&at para'etamol, a 'ommon antip"reti'

and analgesi' drug, 'an 9e used to treat +D( in preterm inants 7it&good ei'a'" and seemingl" e7 side ee'ts. :1@; Ho7ever, it &as

not 9een evaluated in a prospe'tive randomized 'ontrolled trial.

%o determine 7&et&er oral para'etamol ma" 9e used as a irstline

drug or +D( in preterm inants, 7e 'ondu'ted a randomized, non

9linded, parallel'ontrolled, nonineriorit" trial to 'ompare itsei'a'" and saet" levels to t&ose o i9uproen. %&e indings are

e=pe'ted to &elp e=tend 'lini'al sele'tions or +D( in preterm

inants.


5/53

Aimto des'ri9e t&e easi9ilit" o earl" administration o sura'tantvia a t&in 'at&eter during spontaneous 9reat&ing 4%a$e Care5 and

'ompare earl" me'&ani'al ventilation 4M5 re


6/53

!TH"DS

Study design # +rospe'tive single 'enter randomized 'ontrolled stud"

Setting #!CU o #e$ai %a&ir Bura$ Maternit" %ea'&ing Hospital

Approval # %&e lo'al et&i's Committee.

Consent #ritten and inormed 'onsent rom parents

Study duration # 1 "ear 4De'/010 to De'/0115


7/53

Inclusion criteria: n9orn preterm inants 7it& gestational age 2@ 7ee$s*

n9orn 7&o suered rom D)*

!$clusion criteria:

nants 7it& maIor 'ongenital anomalies !o parental 'onsent,

nants 7&o re


8/53

Study Design D) 7as diagnosed in inants e=&i9iting t&e ollo7ing s"mptoms

need or supplemental o="gen, ta'&"pnea, grunting and inter'ostal

retra'tions, 7as 'onirmed 9" t"pi'al =ra" and 9lood gas indings.

+atients 7it& signs o D), 7&o 7ere under nC+(+ treatment

and re


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%rocedures:

+reterm inants 7&o re


10/53

E=ogenous sura'tant administration via t&e ne7 te'&ni


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+or'ine sura'tant 4Curosur* C&iesi Farma'euti'i, +arma,tal"5 at a

dose o 100mg$g 41./?m$g5 7as dra7n up in a ?m s"ringe, and

an additional 1 m o air 7as dra7n up into t&e s"ringe ta$ing a''ount

o t&e dead volume o t&e instillation 'at&eter. E=ogenous sura'tant 7as administered in 1 9olus in 20 to A0 se'onds

and t&e tra'&eal 'at&eter 7as immediatel" 7it&dra7n.

During t&e %a$e Care pro'edure, dire't lar"ngos'op" 7as perormed

9" using a standard lar"ngos'ope and Miller 00 9lade and

C+(+ support 7as not disrupted.

visualization o vo'al 'ords and repla'ement o 'at&eter 7as not

possi9le 7it&in /0 to 20 se'onds, a urt&er 'at&eterization attempt 7as

postponed or at least 1 minute.

nants 7&o suered severe apnea and 9rad"'ardia 4L 100min5, along7it& desaturation4L 3085 lasting longer t&an /0 se'onds got ++ 9" %

pie'e devi'e.


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+atients 7&o re'eived sura'tant via t&e n)urE te'&ni


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Management ater t&e %a$e Care or n)urE pro'edure 7as as per

standard pra'ti'e at our institution.

Control arterial 9lood gas samples 7ere ta$en / &ours ater t&e

pro'edure.

C+(+ pressure 7as titrated a''ording to 7or$ o 9reat&ing and o="gen re


14/53

Ma=imum a''epta9le settings 7ere sustained C+(+ pressure o

9e"ond 6'm H/O along 7it& an FiO/ o 0.A. nants e='eeding

t&ese limits 7ere intu9ated and a urt&er dose o sura'tant 7as

given i 'lini'all" indi'ated.

Ot&er indi'ations or intu9ation 7ere sustained respirator" a'idosis4pH,6./5 and apnea re


15/53

%o assess t&e demograp&i' and prenatal ris$s, standardized data, su'& as

G(, 9irt& 7eig&t, gender, (pgar s'ore at ? minutes, preterm premature

rupture o mem9ranes and antenatal steroid use regardless o t&e time

interval 9et7een steroid administration and 9irt& 7ere 'olle'ted.

Clini'al data, along 7it& details o ailure o irst attempt during

'at&eterizing t&e tra'&ea, o''urren'e o 'oug&ing or gagging, and need or ++ in t&e %a$e Care pro'edure and sura'tant relu=,

9rad"'ardia, and desaturation in 9ot& pro'edures 7ere

re'orded prospe'tivel".

%&e nC+(+, o="gen re


16/53

+artial pressure o 'ar9on dio=ide and pH values 7ere 'ompared inpaired arterial 9lood gas samples ta$en 9eore and / &ours ater

sura'tant appli'ation.

%&e radiograp&i' severit" o D) 7as graded as normal 4grade 15,

mild 4grade /5, moderate 4grade 25 or severe 4grade @5 9eore t&epro'edures. 16

%&e mode o respirator" management during t&e irst 6/ &ours

o lie 7as noted prospe'tivel".

!eed or M during t&e irst 6/ &ours o lie in inants 7&o &adinitiall" 9een managed 7it& nC+(+ 7as 'lassiied as

ailure o nC+(+.


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%&e primar" out'omes o stud" 7ere )e'ondar" out'omes 7ere B+D7as diagnosed on t&e 9asis o t&e !ational nstitutes o C&ild Healt&

and Development diagnosti' 'riteria.1J

"utcomes:


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ain outcome: %&e ee'ts o t&e %a$e Care te'&ni


19/53

Statistical Analysis

On the basis of our previous experiences with theInSurE techniue! "#$ of patients reuire% intubation

an% &' in

(rst )* hours of +ife, o re%uce the nee%for &'treat.ent

with this new a/e 0are techniue fro. "#$ to 1#$!

weesti.ate% that a sa.p+e si2e 3## for each 4roup wi++

5ie+% 67#$ power,*# he statistica+ eva+uation of the %ata was perfor.e% b5

usin4 S8SS software! version 3),# 9I& S8SS Statistics!

I& 0orporation! Ar.on/! N;


20/53

(9normall" distri9uted data 7ere evaluated 7it& t&e Kolmogorov)mirnov test* +L.0? 7as 'onsidered statisti'all" signii'ant.

%&e a9solute ris$ redu'tion and t&e num9er needed to treat toget&er

7it& J?8 'oniden'e intervals 4Cs5 and t&e relative ris$ 45

7ere 'al'ulated as t&e ee't measures, multinominal logisti'regression used or t&is 'al'ulation.


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R!S&'TS: During t&e stud" period, 2?6 inants 7ere assessed or eligi9ilit".

( total o /?@ inants 7&o 7ere treated 7it& nC+(+ immediatel"

ater 9irt& 7ere assessed or sura'tant treatment* /00 patients 7&o

re


22/53

(rterial 9lood gas anal"sis, 7&i'& 7as o9tained 9eore and / &ours

ater sura'tant treatment and radiologi' s'oring o '&est =ra"s,revealed no signii'ant dieren'es 9et7een t&e / groups 4%a9le /5.

(lteration in FiO/ and +EE+ levels over time in 9ot& groups during

/@ &ours o lie, 7&i'& are demonstrated in Fig / and Fig 2, s&o7ed

similarit".

Coug&ing and gagging 41185 and 9rad"'ardia and desaturation

41685 7ere re'orded as peridosing adverse events in t&e %a$e Care

group.

Failure o t&e irst attempt 7as re'orded in 138 o patients in t&e

%a$e Care group and 108 in t&e n)urE group and t&e dieren'e7as not statisti'all" signii'ant 4+ N.065.

Brad"'ardia and desaturation rates 7ere not statisti'all" dierent

9et7een groups 4138 vs 168, + N .2?5.


23/53

O9served sura'tant relu= during t&e attempt 7as signii'antl"&ig&er in t&e %a$e Care group in 'ontrast to t&e n

)urE group 4/18 vs 108, + N .00/5.

%7elve per'ent 4n N 1/5 o patients &ad severe apnea lasting./0

se'onds and 9rad"'ardia 4L100min5 re


24/53

+ulmonar" out'omes o 9ot& pro'edures are presented in %a9le /.

Fort" per'ent o patients 4n N @05 in t&e %a$e Care and @J8 4n N @J5

in t&e n)urE group re


25/53

%&e in'iden'e o neonatal mor9idities, su'& as patent du'tusarteriosus 4/38 vs 2/85, ne'rotizing entero'olitis 4?8 vs A85,

intraventri'ular &emorr&age 4108 vs 1A85, and retinopat&" o

prematurit" 428 vs @85, 7ere similar 9et7een groups 4+ .0?5.

Ho7ever, t&e in'iden'e o moderate to severe B+D among patients

7&o survived to dis'&arge 7as signii'antl" &ig&er in t&e n)urE

group 4/0./8 vs 10.28, + N .00J5.

Four patients in t&e n)urE and 1 patient in t&e %a$e Care group

'onstituted patients 7it& severe B+D and 7ere dis'&arged to &ome

7it& supplemental o="gen treatment. %&e B+D rate 7as signii'antl" lo7er among t&e inants treated 7it&

t&e %a$e Care te'&ni0./6, J?8 C >0.6/ to >0.15 4%a9le

25.


26/53

)u9group anal"sis, in'luding preterm inants at /3 7ee$sgestation, revealed t&at B+D 7as signii'antl" lo7er among patients

in t&e %a$e Care group in 'omparison 7it& t&e n)urE group 412.A8

vs /A./8, + N .003, >0./1 J?8 C >0.A? to >0.065 4%a9le 25.

Overall mortalit" rates 7ere similar in 9ot& groups 41A8 and 128,

+ N .A35.

!o signii'ant dieren'e 9et7een groups 7as reported or t&e

'om9ined out'ome o B+D or deat& 4//8 and 2/8, + N .1?5.


27/53

Ta(le )* %atient characteristics and %renatal Ris+ ,actors of the

groups*

Characteristic Ta+e care -n . )//0 InSur! -n . 1/0 % value

Gestational 7ee$, mean P )D /3 P/./ /3.2 P /./ 0./?

Birt& 7eig&t 4g5 , mean P )D 10J2 P /60 11/1 P /60 0.@A

(ntenatal steroids, n 485 62 4625 314315 0.13

++OM, n 485 2/ 42/5 /1 4/15 0.06

Male gender, n 485 A04A05 ?/4?/5 0./?

Deliver" t"pe, Cesarean 9irt&, n485

6?46?5 324325 0.1A

?minute (pgar, 4minma=5 64?J5 64AJ5 0.1?


28/53

DISC&SSI"2 :

%&is single'enter prospe'tive randomized 'ontrolled trial demonstrated

t&at 9olus sura'tant administration during spontaneous 9reat&ing via a

t&in nasogastri' tu9e, du99ed t&e %a$e Care

te'&ni


29/53

In this .etho%! 4enera++5 the catheter is p+ace% with&a4i++ forceps into the trachea un%er %irect +ar5n4oscop5an% surfactant is app+ie% over a perio% of 3 to 1 .inutes,

Dar4avi++e et a+3? %escribe% the use of a .ore stab+evascu+ar catheter for the proce%ure! which a++owe%

p+ace.ent without use of the &a4i++ forceps,he a/e 0are techniue is the co.bination

of both techniues %escribe% previous+5@ we use a

thin shortene% naso4astric tube for eas5 rep+ace.ent

without &a4i++ forceps an% pre.e%ication an%a%.inister surfactant in a shorter %uration 91#?#

secon%s


30/53

e o9served e7er peridosing events,su'& as ailure o t&e irstattempt o 'at&eterization, 9rad"'ardia, sura'tant relu=, and ++

re


31/53

(lt&oug& GQpel et alJ used dierent sura'tant '&oi'es, 7e used a

single one pora'tant .

e '&ose pora'tant 9e'ause its avora9le ei'a'" in smaller volumes

gives t&e opportunit" or eas" 9olus administration* t&ereore, a

'onsidera9l" lo7er rate o relu= 7ould 9e o9served.

e reported t&at pora'tant a &ad rapid onset o a'tion, less need or

redosing, rapid e=tu9ation, and &ig&er survival ree o B+D in

preterm inants. /@

Moreover, amanat&an et al/? also reported similar indings t&at

en'ouraged treatment 7it& pora'tant in our stud".

%&e sustained redu'tion in FiO/ ater %a$e Care indi'ated t&at an

ade


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One o t&e most stri$ing results o t&e %a$e Care te'&ni


33/53

e'entl" GQpel et alJ reported t&e results o a multi'entri'

prospe'tive randomized trial in'luding 1/ 'enters and demonstrated

t&at t&e appli'ation o sura'tant via a t&in 'at&eter to spontaneousl"9reat&ing preterm inants re'eiving nC+(+ redu'ed t&e need or

M.

n t&eir trial, t&e (void Me'&ani'al entilation trial, t&e aut&ors

'on'luded t&at alt&oug& t&e" o9served s&orter duration o M in patients 7&o re'eived sura'tant 9" 'at&eter, t&ere 7as no dieren'e

9et7een groups in rates o deat& and serious adverse events,

in'luding B+D.

e t&in$ t&at dii'ulties in standardization o a novel te'&ni


34/53

(lt&oug& it &as 9een demonstrated as easi9le,results o9tained in t&e

%a$e Care trial, 7&i'& 7as a single'enter stud" 7it& onl" pora'tant a

as sura'tant '&oi'e, support t&at standardization s&ould 9e 'onsidered

or t&e ei'a'" o t&e te'&ni


35/53

n t&e )U++O%20 trial, t&e M 43285 rate 7as signii'antl" &ig&er

t&an our 'urrent rate.

(lt&oug& M and B+D rates reported in CO!21 4?J8 and /?85

and CU+(+2/ 4228 and /185 trials 7ere &ardl" similar to ourindings,t&e duration o M 7as signii'antl" s&orter in our stud".

e 'onsidered t&at t&e need or intu9ation and even

9rie ++ 9" 9agging to administer sura'tant in t&e

n)urE met&od ma" 9e &armul to an immature lung and

9" t&ese properties it seems to 9e more invasive t&an t&e

%a$e Care te'&ni


36/53

On t&e ot&er &and, passing a 'at&eter 9et7een t&e 'ords means t&einant 'an pro9a9l" maintain an essentiall" un'&anged respirator"

pattern and per&aps 'ontinue to 9eneit rom nC+(+.

n 'ontrast, tra'&eal intu9ation ma$es e=pirator" 9ra$ing almost

impossi9le and t&e lung 7ill inevita9l" 9e dere'ruited.

Giving manual inlations to ree=pand t&e lungs and a'ilitate

sura'tant spreading ma" per&aps &ave t&e opposite ee't, resulting

in a more uneven sura'tant distri9ution t&an during spontaneous

9reat&ing.

e suggest t&at elimination o t&ese &azardous ee'ts o ++ 7it&intu9ation in t&e %a$e Care pro'edure ma" pla" an important role in

redu'tion o B+D.


37/53

Our trial &ad some limitations, 7&i'& s&ould 9e 'onsidered in uture

studies.

First, during t&e stud" period, all inants 7&o mig&t &ave 9een

eligi9le or t&e stud" 'ould not 9e enrolled 9e'ause o t&e 'on'ernor standardization o t&e pro'edure.

)e'ond, pro9a9le estimated '&allenges 4e=perien'e o p&"si'ians,

availa9ilit" or varia9ilit" o e


38/53

(lt&oug& it &elped to &ave lo7 rate and volume o sura'tant relu=,7e 'ould not 'omment on our te'&ni


39/53

Ta(le 3* %ulmonary "utcomes among Both groups*%a$e Care n)urE + value

)ura'tant administration time, min @@.JP/@.A @3.3P20.2 0.//

pH levels 9eore treatment,meanP)D 6.1@P0.@J 6./6P0.?@ 0./1

pH levels 9eore treatment,meanP)D 6./0P0.A3 6./6P0.A? 0.?1

adiologi' s'oring 9eore treatment, median 2 4/@5 2 4/@5 0./3

adiologi' s'oring ater treatment, median /4125 141/5 0./3

)e'ond dose o )ura'tant //4//5 /14/15 1

Earl" intu9ation 204205 @?4@?5 0.0/

)ua'tant ater intu9ation 6465 104105 0.A3

ate intu9ation 1J41J5 /J4/J5 0.1

+neumot&ora=, n 485 6 465 10 4105 0.A1

+ulmonar" interstitial emp&"sema, n 485 /4/5 2425 1

(tele'tasis A4A5 ?4?5 0.?

+ulmonar" &emorr&age, n 485 ?4?5 6 465 0.6A

(n" M, n 485 @0 4@05 @J 4@J5 0.1/

nC+(+ duration, &, 4minma=5, median 63 4/@6/05 11A4/@@3J5 0.00/

M duration, &, 4minma= 2?.A 406?A5 [email protected]@3J5 0.00A


40/53

Safety of Treatment Eig&t patients in t&e para'etamol group and ourteen o t&e

i9uproen group 7&o did not re'eive t&e 'omplete 'ourse o

treatment 7ere removed rom t&e trial.

%&ere 7ere no signii'ant dieren'es 9et7een t&e t7o groups in t&ein'iden'e o oliguria, renal ailure, !EC, H grade and serum'reatinine 'on'entration.

Ho7ever, dieren'es in t&e in'iden'e rates o gastrointestinal 9leeding and &"per9iliru9inemia 9et7een t&e t7o groups 7ere

signii'ant 4+ L0.0?5.

%&ere 7ere no signii'ant dieren'es 9et7een t&e t7o groups inadverse events, in'luding B+D, +, !EC, sepsis, O+ and deat&

rom one 7ee$ ater treatment on7ard during t&e &ospitalizationperiod 4%a9le 25.

Ta(le 4 The rates of B%D and 5 re6uirements among groups


41/53

Ta(le 4* The rates of B%D and 5 re6uirements among groups*

%rimary"utcome

Ta+e Care -n. )//0

InSur! -n .)//0

% value RR 789CI 22T % value

A++ infants

Ear+5 &'!$

1# @? 0.0/ 0.?/ 0.J@ to0./J

A 0.0/

An5 &'! $ @0 @J 0.1/ 0.?A 1 to 0./J 0.03

8D! n 9$< J 410.25 16 4/0./5 0.00J 0./6 0.6/ to 0.1 10 0.00?

/3 7$ nN?J !N??

Ear+5 &'!$

2/ ?/ 0.0/ 0.@2 0.J1 to0.1J

0.0/

An5 &'! $ @? ?J /*/7 0.@/ 0.J@ to0.@6

0.02

8D! n 9$< A412.A5 1A4/A./5 /*//1 /*3) /*;8 to

/*//1; &ave 9een 'ondu'ted on para'etamol treatment o +D( in preterm ne79orns to date.

+ara'etamol 7as not used as t&e drug o '&oi'e 9ut rat&er as our a

supplementar" medi'ation in 'ases 7&ere COR in&i9itors 7ere

inee'tive or 'ontraindi'ated in t&e maIorit" o several related

'ases, in'luding t&e irst 'ase :1@; reported, in 7&i'& para'etamol 7as irst used to 'lose du'tus arteriosus.

(s t&ese previous studies la'$ed sui'ient sample sizes or anal"siso ei'a'" and saet"related a'tors, su'& as gastrointestinal

9leeding, !EC, H, &"per9iliru9inemia and deat&, t&e" 'annot 9eused to support para'etamol as a irstline drug or +D( in pretermne79orns.


43/53

%&ereore, 7e 'ondu'ted a randomized, non9linded,

parallel'ontrolled, non ineriorit" trial in order to 'ompare

oral para'etamol and i9uproen or +D( 'losure inpremature inants.

n our stud", su9Ie'ts 9orn at 2@ 7ee$s o gestation 7ere

'&osen or enrollment 9ased on t&e population

demograp&i's and 'lini'al needs in C&ina.

e ound t&at oral para'etamol &ad good ei'a'" on +D(in preterm inants, and t&e 'losure rate o para'etamol 7as

'ompara9le to t&at o oral i9uproen.


44/53

Furt&ermore, t&e mean num9er o da"s to du'tal 'losure 7as s&orter

in t&e para'etamol group t&an in t&e i9uproen group 42.//P0.1@

da"s vs. 2.61P 0.1A da"s, +N 0.0/05.

Du'tal 'losure in ne79orns is $no7n to 9e dependent on in'reased

9lood o="gen and de'reased vasodilators in'luding prostaglandin

E/ and /. :/;

+rostaglandin s"nt&etase &as t7o dierent 'atal"ti' a'tivities a

'"'loo="genase and a pero=idase. %&e '"'loo="genase a'tivit"'atal"zes ara'&idoni' a'id to orm +GG/, 7&i'& is t&en 'atal"zed

9" t&e pero=idase into +GH/. COR in&i9itors su'& as indomet&a'in

and i9uproen 'ompete 7it& t&e ara'&idoni' a'id su9strate or t&e

'"'loo="genase site* t&us, t&e ee'ts o t&ese drugs are inluen'ed

9" endogenous ara'&idoni' a'id levels. ://,/2;


45/53

(lt&oug& t&e pre'ise me'&anism o a'tion o para'etamol remains

un'ertain, it ma" a't at t&e pero=idase segment o t&e prostaglandins"nt&etase to in&i9it prostaglandin s"nt&esis. :/@,/?;

+ero=idase is a'tivated at 10old lo7er pero=ide 'on'entrations

t&an t&at or '"'loo="genase,:/?,/A; suggesting t&at para'etamol

'an still 7or$ 7ell at de'reased lo'al pero=ide 'on'entrations 4e.g.,

&"po=ia5.

%&eoreti'all", t&ese dieren'es ma" ena9le para'etamol to 7or$

ee'tivel" in t&e situation 7&ere a '"'loo="genase in&i9itor is

inee'tive.


46/53

eopening o t&e du'tus ater 'losure 7as o9served in ive inants

in t&e para'etamol group and in si= inants o t&e i9uproen group.

(ter 'ontinuing t&e drug treatment, t&e du'tus 'losed again in our

patients in 7&i'& it &ad reopened in ea'& group, suggesting t&at

para'etamol is still ee'tive ater t&e du'tal reopening.

egarding t&e drug saet" proile, t&e in'iden'e rates o

gastrointestinal 9leeding and &"per9iliru9inemia in t&e para'etamol

group 7ere signii'antl" lo7er t&an t&ose o t&e i9uproen group. 9uproen is JJ8 protein 9ound, and at &ig&er 'on'entrations, it 'an

9e a 'ompetitive displa'er o 9iliru9in or al9umin 9inding sites,

t&ere9" potentiall" in'reasing t&e ris$ o &"per9iliru9inemia.:/6>

20; n addition, t7o in vivo studies &ave demonstrated t&ati9uproen treatment results in &ig&er pea$ levels o total serum

9iliru9in and longer durations o p&otot&erap". :21,2/;.


47/53

%&is 'urrent stud" &as provided several important impli'ations or t&e 'lini'al

treatment o +D(. First, it demonstrated t&at

para'etamol ma" 9e'ome t&e '&oi'e drug or +D( in preterminants.

Furt&ermore, t&e mean da"s to 'losure 7ere s&orter in t&e para'etamol group t&an

in t&e i9uproen group 42.// P 0.1@ da"s

vs. 2.61 P 0.1A da"s, +N 0.0/05, indi'ating t&at para'etamol 'an

treat +D( more rapidl" 'ompared 7it& i9uproen and 9e 9etter suited or severe 'ases in 7&i'&


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'imitations

Furt&er studies 'on'erning t&e ee't on B+D 7it& sui'ient po7erand metaanal"sis are needed.


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Conclusions

%&e %a$e Care te'&ni


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1. emons S(, Bauer C, O& , Korones )B, +apile (, et al 4/0015 er" lo7 9irt& 7eig&t out'omes o t&e !ational nstitute o C&ild &ealt&

and &uman

development neonatal resear'& net7or$, Sanuar" 1JJ? t&roug& De'em9er 1JJA. !CHD !eonatal esear'& !et7or$. +ediatri's 41065 E1.

/. Hamri'$ )EG, Hansmann G 4/0105 +atent Du'tus (rteriosus o t&e +reterm nant. +ediatri's 41/?5 10/06.

2. Capozzi G, )antoro G 4/0115 +atent du'tus arteriosus pat&op&"siolog", &emod"nami' ee'ts and 'lini'al 'ompli'ations. %&e Sournal o

MaternalFetaland !eonatal Medi'ine 4/@5 1?>1A.

@. Erdeve O, urttutan ), (ltug !, Ozdemir , Go$men %, et al 4/01/5 Oral versus intravenous i9uproen or patent du'tus arteriosus 'losure

a randomized

'ontrolled trial in e=tremel" lo7 9irt&7eig&t inants. (r'& Dis C&ild Fetal !eonatal Ed 4J65 /6J>/32.

?. Go$men %, Erdeve O, (ltug !, Oguz )), Uras !, et al 4/0115 Ei'a'" and saet" o oral versus intravenous i9uproen in ver" lo7 9irt&

7eig&t preterm

inants 7it& patent du'tus arteriosus. S +ediatr 41?35 ?@J>??@.

A. (randa S, FC+C F((+, %&omas 4/00?5 ntravenous 9uproen or +reterm !e79orns. !eoevie7s 4A5 e?1A>e?/2.

6. ao , Br"o7s$" K, Mao S, Bunton D, M'+&erson C, et al 4/0115 Gastrointestinal 'ompli'ations asso'iated 7it& i9uproen t&erap" or

patent

du'tus arteriosus. Sournal o +erinatolog" 4215 @A?>@60.

3. Kus&nir (, +in&eiro SMB 4/0115 Comparison o renal ee'ts o i9uproen versus indomet&a'in during treatment o patent du'tus arteriosus

in 'ontiguous

&istori'al 'o&orts. BMC Clini'al +&arma'olog" 11 3.

J. )&a& !(, Hills !K, ale& !, M'Curnin D, )eidner ), et al 4/0115 elations&ip 9et7een Cir'ulating +latelet Counts and Du'tus (rteriosus

+aten'" ater

ndomet&a'in %reatment. S +ediatr 41?35 J1J>J/2.

10. O&lsson (, alia , )&a& )) 4/0105 9uproen or t&e treatment o patent du'tus arteriosus in preterm andor lo7 9irt& 7eig&t inants.

Co'&rane Data9ase o )"stemati' evie7s /010, ssue @. (rt. !o CD002@31. DO 10.100/1@[email protected]@

11. (drou'&e(mrani , Green ), Glu'$ KM, in S 4/01/5 Failure o a repeat 'ourse o '"'loo="genase in&i9itor to 'lose a +D( is a


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ris$ a'tor or developing '&roni' lung disease in EB inant. BMC +ediatri's 1/ 10.

1/. Ka9ra !), )'&midt B, o9erts ), Do"le , +apile , et al 4/0065 !eurosensor" impairment ater surgi'al 'losure o patent du'tus

arteriosus in e=tremel" lo7 9irt& 7eig&t inants results rom t&e %rial o ndomet&a'in +rop&"la=is in +reterms S +ediatr 41?05 //J>

/2@, /[email protected].

12. Malvi"a M, O&lsson (, )&a& ) 4/0035 )urgi'al versus medi'al treatment 7it& '"'loo="genase in&i9itors or s"mptomati' patent

du'tus arteriosus in preterm inants. Co'&rane Data9ase )"st ev 415 CD002J?1.

1@. Hammerman C, Bin!un (, Mar$o7itz E, )'&immel M), Kaplan M, et al 4/0115 Du'tal 'losure 7it& para'etamol a surprising ne7approa'& to patent du'tus arteriosus treatment. +ediatri's 41/35 e1A13>e1A/1.

1?. Maisels MS, at'&$o SF 4/0025 %reatment o Iaundi'e in lo7 9irt&7eig&t inants. (r'& Dis C&ild Fetal !eonatal Ed 334A5 F@?J>

@A2.

1A. %&e nternational Classii'ation o etinopat&" o +rematurit" revisited 4/00?5 (r'& Op&t&almol 1/2465 JJ1>JJ.

16. Bell MS, %ern9erg S, Feigin D, et al 41J635 !eonatal ne'rotizing entero'olitis. %&erapeuti' de'isions 9ased upon 'lini'al staging.

(nn )urg 136 1.

13. So9e (H, Ban'alari E 4/0015 Bron'&opulmonar" d"splasia. (m S espir Crit Care Med 1A2 16/2.

1J. On'el M, urttutan ), Uras !, (ltug !, Ozdemir , et al 4/0125 (n alternative drug 4para'etamol5 in t&e management o patent

du'tus arteriosus in

i9uproenresistant or 'ontraindi'ated preterm inants. (r'& Dis C&ild Fetal !eonatal Ed J3, FJ@.

/0. urttutan ), e$ta On'el M, (ra"i'i ), Uras !, (ltug !, et al 4/0125 ( dierent irst'&oi'e drug in t&e medi'al management o

patent du'tus arteriosus oral

para'etamol. S Matern Fetal !eonatal Med 4/A5 3/?>3/6.

/1. e$ta On'el M, urttutan ), Degirmen'ioglu H, Uras !, (ltug !, et al 4/0125 ntravenous +ara'etamol %reatment in t&e

Management o +atent Du'tus (rteriosus in E=tremel" o7 Birt& eig&t nants. !eonatolog" 41025 1A?>1A3.


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//. He"mann M(, udolp& (M, )ilverman !H 41J6A5 Closure o t&e du'tus arteriosus in premature inants 9" in&i9ition o prostaglandin

s"nt&esis. ! Engl S Med 4/J?5 ?20>?22.

/2. Friedman F, Hirs'&$lau MS, +rintz M+, +itli'$ +%, Kir$patri'$ )E 41J6A5 +&arma'ologi' 'losure o patent du'tus arteriosus in t&e

premature inant. ! Engl S Med 4/J?5 ?/A>?/J.

/@. GreTen K, Drvota , ester21?./?. u'as , arner %D, oInovi' , Mit'&ell S( 4/00?5 Cellular me'&anisms o a'etaminop&en ole o '"'loo="genase. F()EB S 41J5

A2?>A26.

/A. Kulma'z S, ang H 41JJ?5 Comparison o &"dropero=ide initiator re/@0/2.

/6. (&lors CE 4/00@5 Ee't o i9uproen on 9iliru9inal9umin 9inding. S +ediatr 41@@5 23A>233.

/3. Cooper+eel C, Brodersen , o9ertson ( 41JJA5 Does i9uproen ae't 9iliru9inal9umin 9inding in ne79orn inant serum. +&arma'ol

%o=i'ol 46J5 /J6>/JJ.

/J. )oligard H%, !ilsen OG, Bratlid D 4/0105 Displa'ement o 9iliru9in rom al9umin 9" i9uproen in vitro. +ediatr es 4A65 A1@>A13.

20. Diot C, Ki9leur , Desrere 4/0105 Ee't o i9uproen on 9iliru9inal9umin 9inding in vitro at 'on'entrations o9served during

treatment o patent du'tus arteriosus. Earl" Hum Dev 43A5 21?>216.

21. #e''a E, omagnoli C, De Carolis M+, Costa ), Marra , et al 4/00J5 Does i9uproen in'rease neonatal &"per9iliru9inemia. +ediatri's

41/@5 @30>@3@.

2/. &einlaender C, Helenstein D, al'& E, Berns M, O9laden M, et al 4/00J5 %otal serum 9iliru9in levels during '"'loo="genase

in&i9itor treatment or patent du'tus arteriosus in preterm inants. ('ta +aediatr 4J35 2A>@/.


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