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Pediatrics2014;133;171;originallypublishedonlineDecember30,2013;DOI:
10.1542/peds.20133442
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PEDIATRICSistheofficialjournaloftheAmericanAcademyofPediatrics.Amonthlypublication,
ithasbeenpublishedcontinuouslysince1948.PEDIATRICSisowned,published,andtrademarked
bytheAmericanAcademyofPediatrics,141NorthwestPointBoulevard,ElkGroveVillage,Illinois,
60007.Copyright2014bytheAmericanAcademyofPediatrics.Allrightsreserved.PrintISSN:
00314005.OnlineISSN:10984275.
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POLICY STATEMENT
www.pediatrics.org/cgi/doi/10.1542/peds.2013-3442
abstract
Current practice guidelines recommend administration of surfactant at
or soon after birth in preterm infants with respiratory distress syndrome. However, recent multicenter randomized controlled trials indicate that early use of continuous positive airway pressure with
subsequent selective surfactant administration in extremely preterm
infants results in lower rates of bronchopulmonary dysplasia/death
when compared with treatment with prophylactic or early surfactant
therapy. Continuous positive airway pressure started at or soon after
birth with subsequent selective surfactant administration may be considered as an alternative to routine intubation with prophylactic or
early surfactant administration in preterm infants. Pediatrics
2014;133:171174
BACKGROUND
Current practice guidelines in neonatology recommend administration of surfactant at or soon after birth in preterm infants with
respiratory distress syndrome (RDS).1 However, recent
multicenter randomized controlled trials indicate that nasal
continuous positive airway pressure (CPAP) may be an effective
alternative to pro-phylactic or early surfactant administration. 28
Respiratory support is being achieved more frequently with CPAP
and other less invasive approaches, such as the technique of
intubation, surfactant, and extu-bation (INSURE).9
Experimental evidence documents that mechanical ventilation, particularly in the presence of surfactant deficiency, results in lung injury.
Early randomized clinical trials demonstrated that surfactant administration in infants with established RDS decreased mortality,
bronchopulmonary dysplasia (BPD), and pneumothorax.10
Subsequent trials indicated that early selective administration of
surfactant results in fewer pneumothoraces, less pulmonary interstitial
em-physema, less BPD, and lower mortality compared with delayed
se-lective surfactant therapy.11 Trials of prophylactic administration of
surfactant demonstrated decreased air leaks and mortality compared
with selective surfactant therapy.12 However, infants enrolled in these
trials did not consistently receive early CPAP, an alternative therapy
for the maintenance of functional residual capacity. Furthermore,
control infants were intubated and mechanically ventilated without
exogenous surfactant.
Downloadedfrompediatrics.aappublications.orgatHealthInternetworkonApril12,2014
The INSURE strategy also resulted in
appear to provide further
fewer air leaks and shorter duration of
benefits compared with CPAP.15
ventilation when compared with later
selective surfactant administration with
continued ventilation. However, oxygen
RANDOMIZED CONTROLLED
need and survival at 36 weeks
TRIALS OF NASAL CPAP
postmenstrual age or longer-term
STARTING AT BIRTH
outcomes were not assessed in these
trials.13 It is also worth noting that the
INSURE studies did not con-sistently
Recently published large, multicenter
use early CPAP in the control group. In
randomized controlled trials of profact, a recent large trial not included in
phylactic or early CPAP have enrolled
this meta-analysis did not show a
very immature infants, a group that, in
benefit of the INSURE strategy when
previous trials, benefited from sur7
compared with early CPAP. The
factant treatment. The COIN (CPAP or
INSURE strategy may be more efficaINtubation) Trial of the Australasian
cious if an infant can be rapidly
Trial Network compared the effectiveextubated. Studies in baboons have
ness of nasal CPAP (8 cm of water
demonstrated an increase in the sepressure) to intubation and mechaniverity of pulmonary injury when
cal ventilation in preterm infants who
extubation to CPAP is delayed, thus
were breathing spontaneously at 5
reducing the benefits of surfactant
14
minutes after birth.4 There was a trend
administration. Decisions on extufor a lower rate of death or BPD in
bation may have to be individualized,
infants who received CPAP and used
because some critically ill infants may
fewer corticosteroids post-natally. The
not benefit from rapid extubation.
mean duration of ventila-tion was
Further research is needed to test the
shorter in the CPAP group (3 days in
potential benefits of the INSURE strategy on important long-term outcomes.
the CPAP group and 4 days in the
However, rapid extubation after surventilator group). However, the CPAP
factant administration may not be
group had a higher rate of
achievable or desirable in the most
pneumothorax than the ventilator
immature infants, and decisions to
group (9% vs 3%; P < .001). Although
extubate should be individualized.
surfactant therapy was not required
CPAP can be delivered by several
noninvasive techniques such as nasal
prongs, nasopharyngeal tube, or mask
by using a water-bubbling system
(bubble CPAP) or a ventilator. Although
physician preference for bubble or
ventilator CPAP is common, physiologic
and clinical studies have been inconclusive. It is feasible to provide
noninvasive nasal CPAP starting in the
delivery room, even in extremely preterm infants (2427 weeks gestation),
but the most immature infants had the
highest risk of failure.6 Non-invasive
modes of ventilation, such as nasal
intermittent ventilation, do not
172
Downloadedfrompediatrics.aappublications.orgatHealthInternetworkonApril12,2014
continued
ventilation,
prophylactic
sur-factant
and
extubation to
CPAP, or
CPAP
(without
surfactant).7
There were
no statistically
significant
differences
be-tween the
3 groups, but
when compared with
the
prophylactic
surfactant
group, the RR
of BPD or
death was
0.83 (95% CI:
0.641.09) for
the CPAP
group and
0.78 (95% CI:
0.591.03) for
the IN-SURE
group.
Other trials
have
compared
early CPAP
with
prophylactic
or early
surfactant
administration
. The
CURPAP2
and
Colombian
Network3
trials did not
demonstrate
a difference
in the rate of
BPD between
the 2
treatment
strategies.
Moreover, in
the Columbian Network
trial,3 infants
randomly
assigned to
prophylactic
CPAP had a
higher risk of
pneumothora
x (9%) than
infants
randomly
assigned to
INSURE
(2%).
Infants in
the South
American
Neocosur
Network trial
were
randomly
assigned to
early CPAP
(with rescue
using an
INSURE
strategy) or
oxygen
hood (with
res-cue
using
mechanical
ventilation).8
The early
CPAP
strategy
(and selective of
INSURE, if
needed)
reduced the
need for
mechanical
ventilation
and
surfactant.
Standard
but diverse
CPAP
systems
have been
used in
these and
other large
randomized
controlled
trials
reviewed,
including
bubble
CPAP and
ventilator
CPAP. A
detailed
description
of the
practical
aspects of
using CPAP
systems are
beyond the
scope of this
statement
but are
available in
the
published
literature.18,1
9
Preterm
infants are
frequently
born
precipitously
in hospitals
without the
capability of
CPAP. CPAP
can be
provided with
a bag and
mask or other
compa-rable
devices in
these
circumstances.
However,
special
expertise is
necessary
because
CPAP may not
be easy to use
without
specific
training. Safe
transport
before delivery
may be
preferable
depending on
clinical
circumstances.
PEDIATRICS
Volume 133,
Number 1,
January 2014
Thus, care
should be
individualiz
ed on the
basis of the
capabilities
of health
workers in
addition to
the
patients
condition.
A metaanalysis of
prophylactic
sur-factant
versus
prophylactic
stabiliza-tion
with CPAP
and
subsequent
selective
surfactant
administration
in preterm
infants
showed that
prophylactic
administration of
surfactant
compared
with
stabilization
with CPAP
and selec-tive
surfactant
administration
was associated with
a higher risk
of death or
BPD (RR:
1.12; 95% CI:
1.021.24; P
<
.05).11 The
previously
reported
benefits of
prophylacti
c surfactant
could no
longer be
demonstrat
ed.
It is notable
that infants
as immature
as 24
weeks
gestational
age were
enrolled in
many of the
trials. In a
subgroup
analysis in
the
SUPPORT
trial, the
most
immature
infants (born
at 24 and 25
weeks
gestation)
benefited
the most
from the
CPAP
strategy.
Many
extremely
preterm
infants can
be managed
with CPAP
only; early
application
of nasal
CPAP
(without
surfactant
administrati
on) was
successful
in 50% of
infants
weighing
750 g at
birth in 1
retro-
spective
review.20
Surfactant
administrati
on can be
ex-pensive,
particularly
in lowresource
settings.
Additionally,
intubation
and
mechanical
ventilation
may not be
possible or
desirable in
institutions
with limited
resources.
CPAP
provides an
alternative
for early
respiratory
support in
resourcelimited
settings.
Emerging
evidence
indicates
that early
CPAP is an
effective
strategy for
re-spiratory
support in
extremely
pre-term
infants,
including
very
immature
infants.
CPAP
appears to
be at least
as safe and
effective as
early
surfactant
therapy with
mechanical
ventilation.9
CONCLU
SIONS
Based on
a metaanalysis of
prophylactic
surfactant
versus
CPAP
as well as
on other
trials of
more
selective
early use of
surfactant
versus
CPAP not
included in
the metaanalysis, the
early use of
CPAP with
subsequent
selective
surfactant
administrati
on in extremely
preterm
infants
results in
lower rates
of
BPD/death
when
compared
with
treatment
with
prophylactic
or early
surfactant
therapy
(Level of
Evidence:
1).
Preterm
infants
treated with
early CPAP
alone are not
at increased
risk of
adverse
outcomes if
treatment with
surfactant is
delayed or
not given
(Level of
Evidence: 1).
Early
initiation of
CPAP may
lead to a
reduction in
duration of
mechanical
ventilation
and
postnatal
corticostero
id therapy
(Level of
Evidence:
1).
Infants with
RDS may
vary markedly in the
severity of
the respiratory
disease,
maturity,
and
presence of
other
complication
s, and thus
it is
necessary
to
individualize
patient care.
Care for
these
infants is
pro-vided in
a variety of
care
settings,
and thus the
capabilities
of the
health care
team need
to be
considered.
RECOM
MENDAT
ION
Using CPAP
immediately
after birth
with
subsequent
selective
surfac-tant
administrati
on may be
con-sidered
as an
alternative
to routine
intubation
with prophylactic or
early
surfactant
administration in
preterm
infants (Level
of Evidence:
1, Strong
Recommen-
dation).21 If
it is likely
that respiratory
support with
a ventilator
will be
needed,
early
administration of
surfactant
followed by
rapid
extubation is
preferable to
prolonged
ventilation
(Level of
Evidence: 1,
Strong
Recommen
da-tion).21
173
Downloadedfrompediatrics.aappublications.orgat
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MD,
LEAD
FAAP
AUTH
James
ORS
Walde
mar A.
Carlo,
MD,
FAAP
Richard
A.
Polin,
MD,
FAAP
COMMI
TTEE
ON
FETUS
AND
NEWB
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2012
2013
Lu-Ann
Papile,
MD,
FAAP,
Chairpers
on
Richard
A.
Polin,
Waldema
r A. Carlo,
MD,
FAAP
Rosemari
e Tan,
MD,
FAAP
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RespiratorySupportinPretermInfantsatBirth
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Pediatrics2014;133;171;originallypublishedonlineDecember30,2013;DOI:
10.1542/peds.20133442
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PEDIATRICSistheofficialjournaloftheAmericanAcademyofPediatrics.Amonthly
publication,ithasbeenpublishedcontinuouslysince1948.PEDIATRICSisowned,published,
andtrademarkedbytheAmericanAcademyofPediatrics,141NorthwestPointBoulevard,Elk
GroveVillage,Illinois,60007.Copyright2014bytheAmericanAcademyofPediatrics.All
rightsreserved.PrintISSN:00314005.OnlineISSN:10984275.
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DECLARACIN DE POLTICA
www.pediatrics.org/cgi/doi/10.1542/peds.2013-3442
doi: 10.1542 / peds.2013-3442
Pediatra (Nmeros ISSN: Imprimir, 0031 a 4005; en lnea, desde 1.098 hasta 4.275).
abstracto
Guas de prctica actuales recomiendan la administracin de surfactante durante o
poco despus del nacimiento en recin nacidos prematuros con dificultad
respiratoria syn-Drome. Sin embargo, la reciente multicntrico ensayos controlados
aleatorios indi-cado de que el uso temprano de presin positiva continua con la
posterior
administracin
extremadamente
de
prematuros
surfactante
resulta
en
selectivo
en
menores
tasas
recin
de
nacidos
displasia
DE FONDO
Guas de prctica actuales en neonatologa recomiendan adminis-tracin de
surfactante durante o poco despus del nacimiento en recin nacidos prematuros
con
sndrome
de
dificultad
respiratoria
(SDR).
Sin
embargo,
la
reciente
continua nasal (CPAP) puede ser una alternativa eficaz a favor de la profilctica o la
administracin de surfactante temprano. se est logrando
2-8
apoyo respiratorio
con mayor frecuencia con CPAP y otros mtodos menos invasivos, como la tcnica
de intubacin, surfactante y extu-bacin (ASEGURE).
de
deficiencia
de
surfactante,
los
resultados
en
la
lesin
10
11
12
171
La estrategia ASEGURAR tambin dio lugar a un menor nmero de fugas de aire y una menor
duracin de la ventilacin en comparacin con la administracin de surfactante selectivo
posterior con ventilacin continua. Sin embargo, la necesidad de oxgeno y la supervivencia
en la edad post-menstrual 36 semanas o resultados a largo plazo no fueron evaluados en
estos ensayos.
13
beb puede ser extubado rpidamente. Los estudios realizados en babuinos han demostrado
un aumento en la se-verdad de la lesin pulmonar cuando la extubacin a la CPAP se retrasa,
lo que reduce los beneficios de la administracin de surfactante.
14
extu-bacin puede tener que ser individualizado, porque algunos nios crticamente enfermos
no podrn beneficiarse de extubacin rpida. Se necesita ms investigacin para probar los
beneficios potenciales de la ASEGURAR strat-gia en importantes resultados a largo plazo. Sin
embargo, la extubacin rpida despus de la administracin-sur tensioactivo puede no ser
realizable o deseable en los lactantes ms inmaduros, y las decisiones de la extubacin debe
ser individualizado.
CPAP puede ser entregado por varias tcnicas no invasivas tales como cnulas nasales, tubo
nasofarngeo, o mscara mediante el uso de un sistema de agua burbujeante (burbuja CPAP)
o un ventilador. Aunque la preferencia del mdico de la burbuja o ventilador CPAP es comn,
fisiolgica y los estudios clnicos han sido en definitiva. Es factible proporcionar CPAP nasal no
invasivo que comienza en la sala de partos, incluso en extremadamente prematuros
(gestacin 24-27 semanas), pero los bebs ms inmaduros tenido el mayor riesgo de
fracaso.
hacer
15
y la extubacin. La tasa de muerte o DBP en el grupo de CPAP fue del 48% frente al 51% en
el grupo de surfactante (riesgo relativo [RR]: 0,91; intervalo de confianza del 95% [IC]: 0,83 a
1,01; P = 0,07). Entre los bebs nacidos a las 24 de gestacin y 25 semanas, la tasa de
mortalidad fue menor en el grupo de CPAP que en el grupo de surfactante (20% vs 29%; RR:
0,68; IC del 95%: 0,5- 0,92; P = 0,01). Dos tercios de los nios en el grupo CPAP finalmente
recibieron surfactante. Adems, la duracin de la ventilacin mecnica fue ms corto (25
frente a 28 das), y el uso de la terapia con corticosteroides postnatales se redujo en el grupo
de CPAP (7% vs 13%). La tasa de fugas de aire no fue diferente entre los grupos, y no hubo
efectos adversos de la estrategia de CPAP a pesar de una reduccin en el uso de
surfactante. Este ensayo demostr que la CPAP nasal comenz inmediatamente despus del
nacimiento es una alternativa efectiva y segura a tensioactivo ad-ministracin profilctica o
temprana y puede ser superior. Un estudio de seguimiento a la edad corregida de 18 a 22
meses mostr que pada-oc muerte o deterioro del desarrollo neurolgico en el 28% de los
nios en el grupo de CPAP en comparacin con el 30% de los del grupo de surfactante /
ventilacin (RR: 0,93; 95 % CI: 0,78 a 1,10; P = 0,38)
16
17..
La prueba de Gestin Sala de partos Vermont Oxford Network asign aleatoriamente los nios
nacidos a las 26 a 29 semanas 'a 1 de 3 grupos de tratamiento: surfactante profilctico y
172
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diferencia en la tasa de DBP entre las 2 estrategias de tratamiento. Por otra parte, en el juicio
Colum-bian Red,
neumotrax (9%) que los nios asignados al azar para asegurar (2%). Los recin nacidos en
el juicio Sudamericana NEOCOSUR Red fueron asignados aleatoriamente a CPAP precoz (con
rescate utilizando un ASEGURAR estrategia) o campana de oxgeno (con res-cue usando
ventilacin mecnica).
18,19
Los recin nacidos prematuros nacen con frecuencia precipitadamente en los hospitales sin la
capacidad de CPAP. CPAP puede estar provista de una bolsa y la mscara o en otros
dispositivos compa-rable en estas circunstancias. Sin embargo, la experiencia especial es
necesario porque CPAP puede no ser fcil de usar y sin formacin especfica. Seguridad en el
transporte antes de la entrega puede ser preferible dependiendo de las circunstancias
clnicas.
PEDIATRA Volumen 133, Nmero 1, enero 2014
prematuros
pueden
ser manejados
con
slo CPAP;pronta
20
CONCLUSIONES
Sobre la base de un meta-anlisis de surfactante pro-profilctico frente CPAP
as como en otros ensayos de uso temprano ms selectivo de surfactante en
comparacin con CPAP no incluidos en el meta-anlisis, el uso temprano de CPAP
con la posterior administracin de surfactante selectivo en la ex-madamente
bebs prematuros resulta en menores tasas de DBP / muerte en comparacin
con tratamiento con terapia de surfactante profilctico o precoz (Nivel de
evidencia: 1).
Los recin nacidos prematuros tratados con CPAP precoz solo no estn en mayor riesgo de
resultados adversos si el tratamiento con surfactante se retrasa o no determinado (nivel de
evidencia: 1).
RECOMENDACIN
El uso de CPAP inmediatamente despus del parto con la administracin-surfac tant selectiva
posterior puede ser convicto considerarse como una alternativa a la intubacin de rutina
con-profilctica lctico o principios de surfactante admin-tracin en recin nacidos
prematuros (Nivel de evidencia: 1, Fuerte Recomendacin
dacin).
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21
173
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AUTORES PRINCIPALES
Waldemar A. Carlo, MD, FAAP
Richard A. Polin, MD, FAAP
COMIT DE FETO Y
Referencias
Praveen Kumar, MD, FAAP
William Benitz, MD, FAAP
Eric Eichenwald, MD, FAAP
James Cummings, MD, FAAP
Jill Baley, MD, FAAP
COORDINADORES
Tonse NK Raju, MD, FAAP - Institutos Nacionales de Salud
CAPT Wanda Denise Barfield, MD, FAAP - Centros para el Control y la Prevencin de Enfermedades
PERSONAL
Jim Couto, MA
Engle WA; Academia Americana de Pediatra en el Comit del feto y del recin nacido. El tratamiento
con surfactante de reemplazo para la dificultad respiratoria en el recin nacido pretrmino y
trmino. Pediat-RICS. 2008; 121 (2): 419-432
Sandri F, G Ancora, Lanzoni A, et al. Presin Pro-profilctico nasal positiva continua en las vas
respiratorias en los recin nacidos de 28 a 31 semanas de gestacin: ensayo clnico con-controlado
aleatorio multicntrico. Fetal Arco Dis Child Neonatal Ed. 2004; 89 (5): F394-F398
Rojas MA, Lozano JM, Rojas MX, et al; Red de Investigacin Neonatal colombiano. Surfactante Muy
temprano sin ventilacin obligatoria en los neonatos prematuros tratados con principios de presin
positiva continua: un ensayo aleatorizado y controlado. Pediatra. 2009; 123 (1): 137-142
Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB; COIN prueba Inves-gadores. CPAP
nasal o intubacin al nacer para los bebs muy prematuros. N Engl J Med. 2008; 358 (7): 700-708
Finer NN, Carlo WA, Walsh MC, et al; SUP-PORT Grupo de Estudio de la Shriver NICHD Neonatal
Research Network Eunice Kennedy. CPAP precoz versus surfactante en los recin nacidos
extremadamente prematuros. N Engl J Med. 2010; 362 (21): 1970-1979
Finer NN, Carlo WA, Duara S, et al; Instituto Nacional de De Desarrollo-Neonatal Humanos Red de
Investigacin en Salud y el Nio. Sala De-librea presin continua presin positiva / positiva al final
de la espiracin en neonatos de muy bajo peso al nacer: un ensayo fea-bilidad. Pediatra. 2004;
114 (3): 651-657
Dunn MS, Kaempf J, de Klerk A, et al; Ver-mont Oxford Network DRM Grupo de Estudio. Ensayo
aleatorio comparando 3 enfoques
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en: www.pediatrics.org/cgi/con- tienda / completo / 128/5 / e1069
Tapia JL, Urzua S, Bancalari A, et al; Sur Red NEOCOSUR americano. Ensayo aleatorio de presin positiva
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(1): 75-80, e1
Pfister RH, Soll RF. Respiratoria sup-puerto inicial de recin nacidos prematuros: el papel de la CPAP, el
mtodo de asegurar, y no invasivo ven-tilacin. Clin Perinatol. 2012; 39 (3): 459-481
Soll RF, McQueen MC. Sndrome de dificultad respiratoria. En: Sinclair JC, Bracken B, eds.
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de pulso CPAP y principios. N Engl J Med.2012; 367 (26): 2495-2504
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