Randomized Trial of Prongs or Mask for Nasal Continuous Positive Airway

Pressure in Preterm Infants

Emily A. Kieran, Anne R. Twomey, Eleanor J. Molloy, John F.A. Murphy and Colm
P.F. O'Donnell
Pediatrics 2012;130;e1170; originally published online October 22, 2012;
DOI: 10.1542/peds.2011-3548

The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://pediatrics.aappublications.org/content/130/5/e1170.full.html

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 2012 by the American Academy
of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.

Downloaded from pediatrics.aappublications.org at Indonesia:AAP Sponsored on June 18, 2014

Randomized Trial of Prongs or Mask for Nasal

Continuous Positive Airway Pressure in Preterm Infants
WHATS KNOWN ON THIS SUBJECT: Nasal continuous positive
airway pressure (NCPAP) is commonly given to premature infants
with nasal prongs and nasal masks. Prongs and masks appear to
injure the nose of preterm infants with equal frequency.
WHAT THIS STUDY ADDS: Nasal masks are more effective than
nasal prongs for preventing intubation and mechanical ventilation
in premature infants within 72 hours of starting NCPAP.

abstract
OBJECTIVE: To determine whether nasal continuous positive airway
pressure (NCPAP) given with nasal prongs compared with nasal mask
reduces the rate of intubation and mechanical ventilation in preterm
infants within 72 hours of starting therapy.
METHODS: Infants ,31 weeks gestation treated with NCPAP were
randomly assigned to receive it via either prongs or mask. Randomization was stratied by gestational age (,28 weeks, 2830 weeks)
and according to whether NCPAP was started as a primary treatment
for respiratory distress or postextubation. Infants were intubated and
ventilated if they fullled 2 or more of 5 failure criteria (worsening
signs of respiratory distress; recurrent apnea treated with mask
positive pressure ventilation; fraction of inspired oxygen .0.4 to keep
oxygen saturation .88% sustained for 30 minutes; pH ,7.2 on 2
blood gases $30 minutes apart; PCO2 .9 kPa [68 mm Hg] on 2 blood
gases $30 minutes apart) within 72 hours of starting therapy. The
groups were treated the same in all other respects. We recorded
relevant secondary outcomes and analyzed data by using the
intention-to-treat principle.
RESULTS: We enrolled 120 infants. Thirty-two of 62 (52%) infants
randomly assigned to prongs were intubated within 72 hours,
compared with 16/58 (28%) of those randomly assigned to mask
(P = .007). There were no statistically signicant differences
between the groups in any secondary outcomes.
CONCLUSIONS: In premature infants, NCPAP was more effective at preventing intubation and ventilation within 72 hours of starting therapy
when given via nasal masks compared with nasal prongs. Pediatrics
2012;130:e1170e1176

e1170

AUTHORS: Emily A. Kieran, MB, MRCPI,a,b,c Anne R. Twomey,

MB, FRCPI,a Eleanor J. Molloy, MB, FRCPI, FRCPCH, PhD,a,b,c
John F.A. Murphy, MB, FRCPI,a and Colm P.F. ODonnell, MB,
MRCPI, MRCPCH, FRACP, PhDa,b,c
aThe National Maternity Hospital, Dublin, Ireland; bNational
Childrens Research Centre, Dublin, Ireland; and cSchool of
Medicine and Medical Science, University College Dublin, Dublin,
Ireland

KEY WORDS
infant, newborn, randomized trial, preterm, respiratory, CPAP
ABBREVIATIONS
CPAPcontinuous positive airway pressure
FIO2fraction of inspired oxygen
IQRinterquartile range
NCPAPnasal continuous positive airway pressure
NIPPVnasal intermittent positive pressure ventilation
NMHNational Maternity Hospital
Dr Kieran made substantial contributions to the conception and
design of the study. She acquired the data and made a
substantial contribution to the analysis and interpretation of
the data. She wrote the rst draft of the article. Drs Twomey,
Molloy, and Murphy made substantial contributions to the
design of the study. They critically revised the article for
important intellectual content. Dr ODonnell conceived and
designed the study. He analyzed and interpreted the data. He redrafted the article and revised it for important intellectual
content. All authors approve this version of the article.
This work was presented at the Pediatric Academic Societies/
Asian Society for Pediatric Research Meeting; April 30, 2011
Denver, CO.
No company (or agent thereof) whose products feature in this
study or any competing company (or agent thereof) had any
role in study design or conduct; data collection or
interpretation; the decision to present or publish the data; or
writing this article.
This article is being submitted only to Pediatrics and we will not
submit it elsewhere while it is under consideration at Pediatrics.
Although the results have previously been published in abstract
form (Arch Dis Child. 2011;96 [suppl 1]:A3 and PAS 2011), they
have not previously been published in full.
This trial has been registered with the ISRCTN Register (http://
isrctn.org) (identier ISRCTN43000196).

(Continued on last page)

KIERAN et al

Downloaded from pediatrics.aappublications.org at Indonesia:AAP Sponsored on June 18, 2014

ARTICLE

Nasal continuous positive airway

pressure (NCPAP) is used for the primary treatment of respiratory distress
syndrome in preterm infants.13 Giving
NCPAP to preterm infants after extubation
reduces the need for reintubation and
mechanical ventilation.4 The interfaces
most commonly used to deliver NCPAP
are prongs and masks. Short binasal
prongs (short tubes that t in both
nostrils) are more effective than
a single nasal prong (longer tube in 1
nostril)5,6 or nasopharyngeal prongs
(long tubes in both nostrils).7 Masks
that t over the nose were developed
many years ago8,9 and are commonly
used today (Fig 1).10 Nasal trauma has
been reported with the use of both nasal masks and prongs11,12 and occurs
equally often with each interface.13 The
effectiveness of NCPAP given with these
interfaces has not previously been
compared.
Like the majority of Irish10 and UK14
nurseries, we use the Infant Flow Driver,
Infant Flow Advance, and Infant Flow
SiPAP (Viasys Healthcare, Yorba Linda,
CA) devices to give NCPAP to preterm
infants in our NICU. These devices can
administer NCPAP with both short
binasal prongs and nasal masks (Viasys
Healthcare) that are available in 3 sizes
(small, medium, and large). Before the
study, infants who started NCPAP in our
NICU were placed on nasal prongs or
nasal mask at the discretion of the
treating doctors and nurses, and
prongs were used more often.
We hypothesized that giving NCPAP
with nasal prongs compared with

FIGURE 1
Nasal masks (left) and nasal prongs (right).

nasal mask would reduce the rate of

intubation and mechanical ventilation in preterm infants within 72
hours of starting NCPAP therapy in the
NICU.

METHODS
We conducted this randomized controlled trial at the National Maternity
Hospital (NMH), Dublin, a stand-alone
university maternity hospital with
10 000 deliveries annually. The hospital has a tertiary level NICU to which
150 very low birth weight infants are
admitted annually. Infants were eligible
for inclusion if they were born at ,31
weeks gestation by best obstetric estimate (dated by early obstetric ultrasound or last menstrual period) and
were starting NCPAP for the rst time
in the NICU. We included both infants
who were given NCPAP as primary
treatment of respiratory distress and
infants who were given NCPAP postextubation. Infants with major congenital anomalies were excluded. The
study protocol was approved by the
Ethics Committee at the NMH.
Written informed consent was obtained
before enrollment in the study from
a parent or guardian by 1 of the
members of the research team. Infants
were randomly assigned to receive
NCPAP with either nasal prongs or nasal
mask in a 1:1 ratio. The randomization
was stratied by gestational age (,28
weeks and 2830 weeks) and according to whether the infant started NCPAP
as a primary treatment of respiratory
distress or as an aid to extubation. The
treatment allocation schedule was
generated in permuted blocks of 4 by
using a random number table. The
treatment allocation was contained in
sequentially numbered sealed opaque
envelopes. The next envelope in the
sequence was opened after the decision to start NCPAP had been made
and the continuous positive airway
pressure (CPAP) driver had been set up

in the NICU. Infants receiving NCPAP

postextubation were placed on CPAP
directly after removal of the endotracheal tube. Infants of multiple pregnancies were randomly assigned
individually. Infants were nursed supine if umbilical catheters were in situ
and were otherwise nursed prone. Active mouth closure with chin straps or
other methods were not attempted. All
infants started on a NCPAP pressure of
5 to 7 cm H2O that could be increased
up to a maximum of 9 cm H2O. NCPAP
pressures were not continuously recorded electronically but were recorded manually once an hour from the
machine. Nonsynchronized nasal intermittent positive pressure ventilation
(NIPPV) could be given to infants who
had increasing clinical respiratory
distress, increasing oxygen requirements and/or apnea. The decision to
use NIPPV and all changes to NCPAP
pressure and the pressures and rate
used during NIPPV were at the discretion of treating clinicians.
All infants enrolled in the study received
a loading dose of 10 mg/kg caffeine base.
Infants who received NCPAP as primary
treatment of respiratory distress were
given caffeine shortly after starting
NCPAP. Infants who received NCPAP
postextubation were given caffeine before extubation. Caffeine base was given
regularly at a dose of 2.5 mg/kg 24 hours
after the loading dose and at daily
intervals thereafter. The regular dose of
caffeine could be increased to a maximum of 5 mg/kg daily. Infants on NCPAP
were to remain on their allocated interface for the whole duration of
treatment with NCPAP (ie, if an infant
randomly assigned to receive NCPAP
via nasal prongs was intubated at any
time, he or she received NCPAP by nasal
prongs at all subsequent extubation
attempts).
The primary outcome of our study was
intubation and ventilation within 72
hours of starting NCPAP. Infants were

PEDIATRICS Volume 130, Number 5, November 2012

Downloaded from pediatrics.aappublications.org at Indonesia:AAP Sponsored on June 18, 2014

e1171

intubated and ventilated if they met 2 or

more of 5 failure criteria:

 worsening clinical signs of respiratory distress (increasing tachypnea;

expiratory grunting; intercostal, subcostal, and/or sternal recession);

 apnea treated with positive pressure ventilation (PPV) by mask on

2 or more occasions in 1 hour;

 fraction of inspired oxygen (FIO2)

.0.4 to maintain pulse oxygen saturations $88% for .30 minutes;

 pH ,7.2 on 2 arterial or capillary

blood gases taken .30 minutes
apart; and

 PCO2 .9 kPa (68 mm Hg) on 2 arterial or capillary blood gases

taken .30 minutes apart.
We recorded complications of prematurity as secondary outcomes including
death, necrotizing enterocolitis, intraventricular hemorrhage, respiratory support on day 28, oxygen therapy at 36
weeks corrected gestational age, and
retinopathy of prematurity. All secondary
outcomes were determined before discharge home from hospital unless stated
otherwise.
In the 3 years before this study, 40% of
infants with a birth weight of #1500 g
or ,29 weeks completed gestational
age who received NCPAP as primary
treatment of respiratory distress were
ventilated at our hospital while the rate
of reintubation among those extubated
to NCPAP was lower. The interface on
which infants started was not recorded but was likely to be prongs in the
majority. We estimated that the rate of
intubation in the mask group would
be 50% and that we would need to
enroll 120 infants to show a reduction
in treatment failure from 50% to
25% with a 2-tailed type I error rate
of 0.05 and a power of 80%. An external
data monitor analyzed the data
from the rst 60 infants enrolled and
recommended completing enrollment.
Data were analyzed by using the
e1172

intention-to-treat principle by using

PASW version 18 software (SPSS Inc,
Chicago IL). We report the primary
outcome and dichotomous secondary
outcome data as proportions and compared the groups by using nonparametric tests (Pearson x2). We report
secondary continuous outcome data as
mean (SD) when the data were normally
distributed and median (interquartile
range [IQR]) when the data were
skewed, and we compared the groups
by using parametric (t test) and nonparametric tests (Mann-Whitney U test)
as appropriate. We considered P values
,.05 statistically signicant.

RESULTS
One hundred forty-ve infants born at
,31 weeks gestation were admitted to
the NICU of the NMH between August
2009 and November 2010. Twenty-ve
infants were not enrolled into the
study (Fig 2); 120 infants were randomly
assigned, 62 to prongs and 58 to masks.
The groups were well matched for
gestational age, birth weight, gender,
mode of delivery, age at randomization,

and duration of ventilation before randomization (Table 1). More than 90% of
infants in each group were exposed to
antenatal steroids, and approximately
half of enrolled infants had been intubated and received surfactant before
randomization. Among infants who were
randomly assigned post-extubation, the
median FIO2 at randomization was not
different between the groups (Table 2).
Thirty-two of the 62 (52%) infants randomly assigned to nasal prongs were
intubated and ventilated within 72
hours of starting NCPAP compared with
16/58 (28%) infants randomly assigned
to nasal mask (P = .007, number needed
to treat = 4). One infant randomly
assigned to prongs was intubated
without reaching the prespecied failure criteria. Per-protocol analysis of
the data revealed a statistically significant difference in the primary outcome between the groups (P = .012).
The most common reasons that infants
reached failure criteria were clinical
signs of respiratory distress and FIO2 .
0.4 (Table 3). The median NCPAP pressure among infants who reached the

FIGURE 2
Patient recruitment.

KIERAN et al

Downloaded from pediatrics.aappublications.org at Indonesia:AAP Sponsored on June 18, 2014

ARTICLE

TABLE 1 Patient Demographics

Gestational age, wta
Birth wt, ga
Boyb
Vaginal deliveryb
Antenatal steroid exposureb
Post-extubationb
Surfactant prerandomizationb
Age at randomization, hc
Duration of ventilation pre randomization, hc
Apgar score at 5 mina
Outbornb

Prongs, N = 62

Mask, N = 58

28 (2)
1058 (297)
38 (61)
21 (34)
59 (95)
32 (52)
31 (50)
6 (039)
6 (035)
8 (2)
7 (11)

28 (2)
1095 (300)
39 (67)
22 (38)
53 (91)
31 (53)
31 (53)
4 (038)
2 (039)
8 (1)
7 (12)

.594
.502
.497
.922
.407
.841
.817
.914
.972
.971
.578

Mean (SD).
Number (%).
c Median (IQR).
b

primary outcome was not different

between the groups (prongs 6 [67]
cm H2O versus mask 6 [57] cm H2O,
P = .818). Infants who reached the
primary outcome did so at a median
(IQR) of 315 (101960) minutes post
randomization, the latest intubation
occurring at 2670 minutes (45 hours)
postrandomization.
Although more infants randomly assigned to prongs were treated with
NIPPV within 72 hours, the difference
between the groups was not statistically signicant (Table 4). There were

no differences between the groups in

other secondary outcomes that we
measured (Table 4). In particular, there
were no differences in the rates of
pneumothorax, severe cranial ultrasound abnormalities, oxygen therapy
at 36 weeks corrected gestational age,
or death before hospital discharge.
Only 3% of infants in both groups had
nasal trauma sufcient to prompt clinicians or nursing staff to change the interface. Two infants randomly assigned to
prongs were temporarily changed to
mask due to nasal trauma on a total of 3

TABLE 2 Demographics and Outcomes for Subgroups by Time of Randomization

Primary Treatment
wka

Gestational age,
Birth wt, ga
Boyb
Age at randomization, hc
Intubated , 72 hb
NIPPV , 72 hb
Intubated post randomizationb
Oxygen at 36 wkb
Postextubation
wka

Gestational age,
Birth wt, ga
Boyb
Surfactant prerandomizationb
Age at randomization, hc
FIO2 at randomizationc
Intubated ,72 hb
NIPPV ,72 hb
Intubated post randomizationb
Oxygen at 36 wkb

Prongs, N = 30

Mask, N = 27

28 (2)
1137 (310)
18 (60)
0 (00)
19 (63)
12 (40)
21 (70)
3 (10)

29 (1)
1228 (340)
17 (63)
0 (01)
11 (41)
4 (15)
14 (52)
4 (15)

.351
.292
.819
.381
.088
.03**
.311
.819

Prongs, N = 32

Mask, N = 31

27 (1)
985 (268)
18 (60)
31 (97)
37 (19104)
0.21 (0.210.24)
13 (41)
14 (44)
19 (59)
7 (22)

27 (1)
979 (204)
17 (63)
31 (100)
34 (8107)
0.21 (0.210.23)
5 (16)
13 (42)
15 (48)
12 (39)

.933
.924
.819
.101
.325
P = .848
.031**
.884
.630
.142

** Result statistically signicant.

a Mean (SD) and compared with x 2.
b Number (%) and compared with t test.
c Median (IQR) and compared with Mann-Whitney U test.

occasions, 1 on day 22 of NCPAP and the

other on day 49 and again on day 65 of
NCPAP. Two infants randomly assigned to
mask group temporarily changed to
prongsdue to nasal trauma, on day 24and
47 of NCPAP. One additional infant randomly assigned to mask changed to
prongs during NCPAP treatment. This infant developed severe lung disease after
Staphylococcus aureus pneumonia. After
13 days of NCPAP (day 32 after birth), he
had increased oxygen requirements, and
the attending clinician was concerned
that leak from the interface might be
a problem. There was no reduction in the
FIO2 with a change to prongs, and the infant was mechanically ventilated 24
hours later. Infants from both groups
who switched interface were treated with
the alternative interface for median (IQR)
of 2 (22) days, a median (IQR) of 3 (25)
percent of the total duration they spent
on NCPAP. No infant had nasal injury that
prompted referral to a plastic surgeon.
More infants randomly assigned to
prongs who were born ,28 weeks
(Table 5) and who started NCPAP postextubation (Table 2) were intubated
within 72 hours of starting therapy;
however, this study was not sufciently
powered to detect differences in subgroups, and these results should be
interpreted with caution.

DISCUSSION
We studied infants treated with NCPAP
both as a primary treatment of respiratory distress and as an aid to
extubation because these are the clinical situations in which we routinely
give NCPAP to preterm infants in our
nursery. Though these populations are
somewhat distinct, we aim to quickly
extubate preterm infants intubated for
treatment of respiratory distress syndrome at our hospital. Thus, when
designing the study, we thought it reasonable to choose treatment failure
within 72 hours of randomization as our
primary outcome as failure within

PEDIATRICS Volume 130, Number 5, November 2012

Downloaded from pediatrics.aappublications.org at Indonesia:AAP Sponsored on June 18, 2014

e1173

TABLE 3 Reasons for NCPAP Failure Among Infants Who Reached the Primary Outcome
Worsening signs of respiratory distress
Apnea treated with positive pressure ventilation
FIO2 . 0.4
pH ,7.2
PCO2 .9 kPa (68 mm Hg)
a
b

Prongs, n = 32

Mask, n = 16

27 (84)
13 (41)
29 (90)
17 (53)a
14 (44)a

14 (88)
4 (25)
14 (88)
8 (50)b
6 (38)b

29/32 infants randomly assigned to prongs.

12/16 infants randomly assigned to mask who reached the primary outcome had 2 blood gases before doing so.

that time would likely be due to respiratory causes, whereas failure after
this time would more likely be due to
nonrespiratory causes. We believed
that if we detected difference in the
primary outcome between the groups,
it would be due to more effective NCPAP
in that group. Of the 21 infants who did
not reach the primary outcome but
were later intubated (8 randomly
assigned to prongs, 13 to mask), 10
were intubated for surgery, 8 in association with infection, and 3 for apnea.
We suspected that failure rates would
differ according to whether infants had
previously been intubated for respiratory distress and so stratied the
randomization on that basis. Overall,
30/57 (53%) of the infants receiving
CPAP as primary treatment were intubated and ventilated within 72 hours of

starting treatment, whereas 18/63

(29%) of the infants treated postextubation were intubated within 72
hours. These rates are comparable
with those seen in other trials of early
NCPAP in preterm infants.1,2 We also
stratied the randomization according
to gestational age because we suspected that failure rates would be
higher in more immature infants; 21/51
(41%) infants ,28 weeks were intubated ,72 hours, compared with 27/69
(39%) infants 28 to 30 weeks. Our
method of randomization resulted in
groups that were well balanced for
demographic data. Infants ,28 weeks
allocated to prongs were randomly
assigned earlier than infants to masks,
though this difference was not statistically different (Table 5). We do not
know whether this difference had an

TABLE 4 Patient Outcomes

Intubated ,72 ha
NIPPV ,72 ha
Intubated post randomizationa
Surfactant post randomizationa
Duration of mechanical ventilation postrandomization, hb
Duration of NCPAP, hb
Pneumothorax post randomizationa
Respiratory support at day 28a
Postnatal steroidsa
Oxygen at 36 wka
PDA treated medicallya
PDA ligationa
Necrotizing enterocolitisa
Bacterial sepsisa
IVH grade 34 and/or cystic PVLa
Retinopathy of prematurity $stage 2a
Death before dischargea
Nasal traumaa
Switched interfacea

Prongs, N = 62

Mask, N = 58

32 (52)
26 (42)
40 (65)
18 (29)
14 (0119)
260 (91468)
4 (6)
29 (42)
2 (3)
10 (16)
17 (27)
4 (6)
7 (11)
25 (40)
3 (5)
14 (23)
7 (11)
2 (3)
2 (3)

16 (28)
17 (29)
29 (50)
10 (17)
2 (0145)
307 (125650)
1 (2)
26 (45)
1 (2)
16 (28)
18 (31)
4 (7)
8 (14)
27 (47)
2 (3)
12 (21)
4 (7)
2 (3)
3 (5)

.007**
.149
.216
.127
.715
.523
.331
.759
.624
.350
.565
.922
.279
.687
.388
.754
.391
.946
.594

IVH, intraventricular hemorrhage; PDA, patent ductus arteriosus; PVL, periventricular leukomalacia.
** Statistically signicant result.
a Number (%).
b Median (IQR).

e1174

effect on the difference we observed

between the groups.
The major weakness of our study was the
unblinded nature of the intervention and
the consequent potential for the bias of
eitheror both caregivers and/oroutcome
assessors to inuence our results. Although NCPAP pressures could be increased up to 9 cm H2O and NIPPV started
at the discretion of the treating clinician,
there were no predened criteria as to
when pressures should be increased or
NIPPV commenced. The median NCPAP
pressure among infants who reached
the primary outcome was not different
between the groups. Although NIPPV was
given to more infants randomly assigned
to prongs within 72 hours of randomization, the difference was not statistically signicant. The use of NIPPV did not
appear to delay intubation just beyond
72 hours in any enrolled infant; the earliest intubation among the 21 infants
who did not reach the primary outcome
but were subsequently intubated was on
day 5 postrandomization. All enrolled
infants received a loading dose of caffeine and were given it at 24-hour intervals thereafter at a dose of 2.5 mg/kg,
which could be increased. We did not
record the regular dose of caffeine given
to enrolled infants. However, because
most infants who reached the primary
outcome did so early (75% within 16
hours), and only 9 infants (5 randomly
assigned to prongs, 4 randomly assigned
to mask) failed .24 hours after randomization, it is most unlikely that there
was a signicant difference in the dose
of caffeine either group received. To
minimize bias in assessment of the primary outcome, we used prespecied
failure criteria. These criteria were
agreed and are used in clinical practice
by the neonatologists at our NICU and
are similar to those used in recent randomized trials of early NCPAP in preterm
infants.13 These criteria were observed
in all but 1 infant, and per-protocol
analysis of the data revealed a

KIERAN et al

Downloaded from pediatrics.aappublications.org at Indonesia:AAP Sponsored on June 18, 2014

ARTICLE

TABLE 5 Demographics and Outcomes for Infants in Different Gestational Age Strata
Infants ,28 wk

Prongs, N = 28

Mask, N = 23

Gestational age, wka

Birth wt, ga
Boyb
Primary treatmentb
Surfactant prerandomizationb
Age at randomization, hc
Intubated ,72 hb
NIPPV ,72 hb
Intubated post randomizationb
Oxygen at 36 wkb

26 (1)
888 (206)
19 (68)
6 (21)
22 (79)
26 (669)
16 (57)
9 (32)
22 (79)
7 (25)

26 (1)
904 (145)
14 (61)
2 (19)
21 (91)
51 (13129)
5 (22)
11 (48)
14 (61)
6 (26)

.774
.757
.603
.386
.343
.255
.011**
.254
.382
.978

Infants 2831 wk
Gestational age, wka
Birth wt, ga
Boyb
Primary treatmentb
Surfactant prerandomizationb
Age at randomization, hc
Intubated ,72 hb
NIPPV ,72 hb
Intubated post randomizationb
Oxygen at 36 wkb

Prongs, N = 34
29 (1)
1198 (289)
19 (56)
24 (71)
9 (26)
0 (012)
16 (47)
17 (50)
18 (53)
3 (9)

Mask, N = 35
29 (1)
1220 (311)
25 (71)
25 (71)
10 (29)
1 (04)
11 (31)
6 (17)
15 (43)
10 (29)

P
.762
.761
.179
.148
.101
.969
.184
.004**
.431
.115

** Result statistically signicant.

a Mean (SD) and compared with x 2.
b Number (%) and compared with t test.
c Median (IQR) and compared with Mann-Whitney U test.

statistically signicant difference in the

primary outcome between the groups. It
is noteworthy that before this study
most staff at our nursery preferred to
use prongs and that we hypothesized
that prongs were more effective.
Although we did not directly measure it,
we speculate that nasal masks were
more effective than nasal prongs by
delivering higher NCPAP pressure to the
nasopharynx. By the nature of their design, binasal prongs reduce the internal
diameter of the nose. They may, therefore, increase resistance and reduce the
pressure delivered to the airway. An invitro study revealed reductions in the
pressure across binasal prongs used for
NCPAP in preterm infants with the largest
pressure drops seen with the smallest
prongs at the highest rates of ow of

gas.15 This may partly explain the

marked difference in failure rates we
observed among more immature infants
who were likely to have received NCPAP
through the smallest binasal prongs.
Our ndings are applicable in units
where the CPAP devices that we studied
are used. Nasal masks compatible with
these devices have been available for
many years and had been used at our
hospital for .5 years before this study.
They are not more difcult to use than
binasal prongs and are used in the
majority of Irish10 and many UK units.14
The connection to the CPAP circuit is the
same for the mask as that for the
binasal prongs, and no specic training
is required to use the mask. We did not
study other CPAP-generating devices (eg,
bubble CPAP, ventilator-derived CPAP),

and so we do not know if masks are

more effective than prongs when used
with these devices. Similarly, because
we did not attempt active closure of the
mouth in our study by using chin straps,
paciers, or other methods, we do not
know if our ndings are applicable in
these circumstances. However, given the
large treatment effect we observed,
these questions merit examination in
randomized studies.
Our study agreed with a previous study
that revealed that nasal trauma occurred in a small proportion of infants,
with equal frequency with each interface
and after several weeks of therapy.13 We
also agree with other studies that
revealed that trauma related to nasal
prongs tends to be maximum around
the medial aspect of the nasal septum
and the columella, whereas trauma related to nasal masks is more often seen
at the junction of the nasal septum and
philtrum and at the glabella.11,12 As
masks and prongs cause nasal trauma
in differing distribution, the interface
used is alternated in many units. If such
an approach is to be used, we recommend that infants are started on nasal
mask and that the interface only be alternated after 72 hours.

CONCLUSIONS
In premature infants, NCPAP was more
effective at preventing intubation and
ventilation within 72 hours of starting
therapy when given via nasal masks
compared with nasal prongs.

ACKNOWLEDGMENT
Thanks to Professor Peter Davis for his
interim analysis of our data.

REFERENCES
1. Morley CJ, Davis PG, Doyle LW, Brion LP,
Hascoet JM, Carlin JB; COIN Trial Investigators. Nasal CPAP or intubation at birth
for very preterm infants. N Engl J Med.
2008;358(7):700708

2. Finer NN, Carlo WA, Walsh MC, et al; SUPPORT

Study Group of the Eunice Kennedy Shriver
NICHD Neonatal Research Network. Early
CPAP versus surfactant in extremely preterm
infants. N Engl J Med. 2010;362(21):19701979

3. Sandri F, Plavka R, Ancora G, et al; CURPAP Study

Group. Prophylactic or early selective surfactant combined with nCPAP in very preterm
infants. Pediatrics. 2010;125(6). Available at:
www.pediatrics.org/cgi/content/full/125/6/e1402

PEDIATRICS Volume 130, Number 5, November 2012

Downloaded from pediatrics.aappublications.org at Indonesia:AAP Sponsored on June 18, 2014

e1175

4. Davis PG, Henderson-Smart DJ. Nasal continuous positive airways pressure immediately after extubation for preventing
morbidity in preterm infants. Cochrane
Database Syst Rev. 2003; (2):CD000143
5. Davis PG, Davies MW, Faber B. A randomised controlled trial of two methods of
delivering nasal continuous positive airway
pressure after extubation to infants weighing less than 1000 g: binasal (Hudson) versus single nasal prongs. Arch Dis Child Fetal
Neonatal Ed. 2001;85(2):F82F85
6. De Paoli AG, Davis PG, Faber B, Morley CJ.
Devices and pressure sources for administration of nasal continuous positive airway
pressure (NCPAP) in preterm neonates.
Cochrane Database Syst Rev. 2008; (1)
CD002977 doi:10.1002/14651858.CD002977
7. Roukema H, O Brien K, Nesbitt K, Zaw W. A
randomized controlled trial of infant ow
continuous positive airway pressure (CPAP)
versus nasopharyngeal CPAP in the extubation

8.

9.

10.

11.

of babies # 1250 grams. Pediatr Res. 1999;

45:318A
Cox JMR, Boehm JJ, Millare EA. Individual
nasal masks and intranasal tubes. A noninvasive neonatal technique for the delivery
of continuous positive airway pressure
(CPAP). Anaesthesia. 1974;29(5):597600
Kattwinkel J, Fleming D, Cha CC, Fanaroff
AA, Klaus MH. A device for administration of
continuous positive airway pressure by the
nasal route. Pediatrics. 1973;52(1):131134
Kieran EA, Walsh H, ODonnell CPF. Survey of
nasal continuous positive airways pressure
(NCPAP) and nasal intermittent positive
pressure ventilation (NIPPV) use in Irish
newborn nurseries. Arch Dis Child Fetal
Neonatal Ed. 2011;96(2):F156
Robertson NJ, McCarthy LS, Hamilton PA,
Moss ALH. Nasal deformities resulting from
ow driver continuous positive airway
pressure. Arch Dis Child Fetal Neonatal Ed.
1996;75(3):F209F212

12. Fischer C, Bertelle V, Hohlfeld J, ForcadaGuex M, Stadelmann-Diaw C, Tolsa JF. Nasal

trauma due to continuous positive airway
pressure in neonates. Arch Dis Child Fetal
Neonatal Ed. 2010;95(6):F447F451
13. Yong SC, Chen SJ, Boo NY. Incidence of nasal trauma associated with nasal prong
versus nasal mask during continuous positive airway pressure treatment in very low
birthweight infants: a randomised control
study. Arch Dis Child Fetal Neonatal Ed. 2005;
90(6):F480F483
14. Owen LS, Morley CJ, Davis PG. Neonatal
nasal intermittent positive pressure ventilation: a survey of practice in England.
Arch Dis Child Fetal Neonatal Ed. 2008;93
(2):F148F150
15. De Paoli AG, Morley CJ, Davis PG, Lau R,
Hingeley E. In vitro comparison of nasal
continuous positive airway pressure devices
for neonates. Arch Dis Child Fetal Neonatal
Ed. 2002;87(1):F42F45

(Continued from rst page)

www.pediatrics.org/cgi/doi/10.1542/peds.2011-3548
doi:10.1542/peds.2011-3548
Accepted for publication Jul 10, 2012
Address correspondence to Colm ODonnell, MB, MRCPI, MRCPCH, FRACP, PhD, Department of Neonatology, The National Maternity Hospital, Holles St, Dublin 2,
Ireland. E-mail: codonnell@nmh.ie
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright 2012 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE: The authors have indicated they have no nancial relationships relevant to this article to disclose.
FUNDING: The investigators were supported with seed funding from the National Childrens Research Centre.

e1176

KIERAN et al

Downloaded from pediatrics.aappublications.org at Indonesia:AAP Sponsored on June 18, 2014

Randomized Trial of Prongs or Mask for Nasal Continuous Positive Airway

Pressure in Preterm Infants
Emily A. Kieran, Anne R. Twomey, Eleanor J. Molloy, John F.A. Murphy and Colm
P.F. O'Donnell
Pediatrics 2012;130;e1170; originally published online October 22, 2012;
DOI: 10.1542/peds.2011-3548
Updated Information &
Services

including high resolution figures, can be found at:

http://pediatrics.aappublications.org/content/130/5/e1170.full.
html

References

This article cites 15 articles, 9 of which can be accessed free

at:
http://pediatrics.aappublications.org/content/130/5/e1170.full.
html#ref-list-1

Subspecialty Collections

This article, along with others on similar topics, appears in

the following collection(s):
Fetus/Newborn Infant
http://pediatrics.aappublications.org/cgi/collection/fetus:newb
orn_infant_sub
Pulmonology
http://pediatrics.aappublications.org/cgi/collection/pulmonolo
gy_sub
Respiratory Tract
http://pediatrics.aappublications.org/cgi/collection/respiratory
_tract_sub

Permissions & Licensing

Information about reproducing this article in parts (figures,

tables) or in its entirety can be found online at:
http://pediatrics.aappublications.org/site/misc/Permissions.xh
tml

Reprints

Information about ordering reprints can be found online:

http://pediatrics.aappublications.org/site/misc/reprints.xhtml

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 2012 by the American Academy of Pediatrics. All
rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.

Downloaded from pediatrics.aappublications.org at Indonesia:AAP Sponsored on June 18, 2014