Comparison of Devices for Newborn Ventilation in the Delivery Room

Edgardo Szyld, MD, MSc1, Adriana Aguilar, MD1,2, Gabriel A. Musante, MD, MSc1,3, Nestor Vain, MD1, Luis Prudent, MD1,
Jorge Fabres, MD, MSPH4, and Waldemar A. Carlo, MD5, on behalf of the Delivery Room Ventilation Devices Trial Group*

Objective To evaluate the effectiveness and safety of a T-piece resuscitator compared with a self-inflating bag for
providing mask ventilation to newborns at birth.
Study design Newborns at $26 weeks gestational age receiving positive-pressure ventilation at birth were
included in this multicenter cluster-randomized 2-period crossover trial. Positive-pressure ventilation was provided
with either a self-inflating bag (self-inflating bag group) with or without a positive end-expiratory pressure valve or a
T-piece with a positive end-expiratory pressure valve (T-piece group). Delivery room management followed Amer-
ican Academy of Pediatrics and International Liaison Committee on Resuscitation guidelines. The primary outcome
was the proportion of newborns with heart rate (HR) $100 bpm at 2 minutes after birth.
Results A total of 1027 newborns were included. There was no statistically significant difference in the incidence of
HR $100 bpm at 2 minutes after birth between the T-piece and self-inflating bag groups: 94% (479 of 511) and 90%
(466 of 516), respectively (OR, 0.65; 95% CI, 0.41-1.05; P = .08). A total of 86 newborns (17%) in the T-piece group
and 134 newborns (26%) in the self-inflating bag group were intubated in the delivery room (OR, 0.58; 95% CI, 0.4-
0.8; P = .002). The mean
SD maximum positive inspiratory pressure was 26
2 cm H2O in the T-piece group vs
28
5 cm H2O in the self-inflating bag group (P < .001). Air leaks, use of drugs/chest compressions, mortality, and
days on mechanical ventilation did not differ significantly between groups.
Conclusion There was no difference between the T-piece resuscitator and a self-inflating bag in achieving an HR
of $100 bpm at 2 minutes in newborns $26 weeks gestational age resuscitated at birth. However, use of the T-
piece decreased the intubation rate and the maximum pressures applied. (J Pediatr 2014;-:---).

See editorial, p  and

related article, p 

A
pproximately 10% of infants require some assistance to begin breathing at birth. Of these, roughly 50% need assisted
ventilation, and less than 10% require extensive resuscitation.1,2 The most important action in the resuscitation of a
depressed newborn in the delivery room is to establish effective ventilation.3 To date, there is insufficient evidence
regarding the optimal device for establishing effective ventilation in newborns at birth. Current International Liaison Commit-
tee on Resuscitation (ILCOR) and American Academy of Pediatrics (AAP)/American Heart Association (AHA) recommenda-
tions state that ventilation of the newborn can be performed effectively with a flow-inflating bag, a self-inflating bag, or a
pressure-limited T-piece resuscitator.3,4 An increase in heart rate (HR) remains the most sensitive indicator of resuscitation
efficacy.4
Self-inflating bags are the most commonly used manual ventilation devices for
providing positive-pressure ventilation (PPV) at birth.5 In recent years, the T-
piece has been included as an alternative device for ventilation in the delivery 1
From the Research Department, FUNDASAMIN,
room, and its use is becoming more widespread.5-7 Several studies have Fundacio
n para la Salud Materno Infantil; Masters 2

Program in Clinical Trials, Universidad Abierta

compared the effectiveness of both devices by testing providers with different 3
Interamericana; Department of Pediatrics, Facultad de
Ciencias Biome
dicas, Universidad Austral, Buenos Aires,
levels of training in simulated neonatal resuscitation on mannequins, and found 4
Argentina; Division of Pediatrics, School of Medicine,
that the resulting pressures are lower and more consistent when using the Pontificia Universidad Cato
lica de Chile, Santiago, Chile;
and 5Department of Pediatrics, University of Alabama at
Birmingham, Birmingham, AL
*A list of members of the Delivery Room Ventilation
Devices Trial Group is available at www.jpeds.com
AAP American Academy of Pediatrics (Appendix).
AHA American Heart Association Supported by Fundacio
n para la Salud Materno Infantil
BPD Bronchopulmonary dysplasia (FUNDASAMIN), the National Ministry of Science and
Technology, Argentina (PICT-O- Austral 2008 # 77), the
FiO2 Fraction of inspired oxygen Neonatal Resuscitation Program, Covidien, USA
GA Gestational age (101409), and Fisher & Paykel. Ambu donated the self-
inflating bag and PEEP valves, Fisher & Paykel donated
HR Heart rate the T-piece resuscitators, circuits, and masks, Unic
ILCOR International Liaison Committee on Resuscitation company, Masimo donated most of the pulse oximeters,
PEEP Positive end-expiratory pressure and Medix donated 3 pulse oximeters. The authors
declare no conflicts of interest.
PPV Positive-pressure ventilation
Registered with ClinicalTrials.gov: NCT00443118.
SpO2 Oxygen saturation
VLBW Very low birth weight 0022-3476/$ - see front matter. Copyright ª 2014 Elsevier Inc.
All rights reserved. http://dx.doi.org/10.1016/j.jpeds.2014.02.035

1
THE JOURNAL OF PEDIATRICS  www.jpeds.com
T-piece.8-11 One small study compared the T-piece with a
positive end-expiratory pressure (PEEP) valve and a self-
inflating bag without a PEEP valve in extremely preterm in-
fants, and found no difference in oxygen saturation (SpO2) at
5 minutes after birth.12 No randomized controlled study has
compared the effectiveness of these 2 devices in the delivery
room under standard clinical practice. Thus, the aim of the
present study was to evaluate the effectiveness and safety of
a T-piece compared with a self-inflating bag for providing
ventilation through a face mask to newborns at birth.
Methods
This was a cluster-randomized, open-label, 2-period cross-
over trial performed in 11 centers from 5 countries
(Argentina, Chile, Peru, Italy, and the US) that included pub-
lic, private, and university hospitals. The protocol, the
informed consent form, and the parent information material
were approved by the Institutional Review Board of each
participating center. Following Institutional Review Board
guidelines and in compliance with each country’s regula-
tions, prenatal consent was requested for each admitted preg-
nant woman in 4 hospitals in Argentina and 1 hospital in
Peru, and postnatal consent to analyze perinatal and
follow-up data was requested in 3 centers in Chile, 1 center
in Italy, and 1 center in the US. An informed consent waiver
using an opt-out approach was approved by the Institutional
Review Board in 1 center in the US considering both devices
as standards of care.
Newborn infants at $26 weeks gestational age (GA)
receiving PPV through a face mask at birth, in accordance
with current Neonatal Resuscitation Program (AAP/AHA)
and ILCOR recommendations,4,13,14 were eligible for enroll-
ment. Infants were excluded who required immediate endo-
tracheal intubation at birth, presented with a major
congenital malformation, or were part of a multiple birth.
(Because an extra individual was necessary for each recruited
infant, it was considered logistically impossible to enroll most
of the multiples, and so to avoid a source of bias, we decided
to exclude all of them.) We did not include infants at
<26 weeks GA, because many of them would have been intu-
bated immediately after birth, thereby increasing the hetero-
geneity of the sample. In addition, neonates at <26 weeks GA
were also excluded owing to difficulties in standardizing their
initial management approach.
Interventions
Each center was randomized to ventilate infants at birth with
1 of 2 devices, a T-piece or self-inflating bag. The order of
intervention was assigned at random, and the group assign-
ment was not submitted to the centers until study initiation.
Before the start of patient enrollment, health care providers
were trained in the use of the device assigned for that period.
After 50 patients were enrolled came an interval without
intervention (“washout period”), during which the health
team was trained in the use of the alternate device and the
2 Szyld et al
Vol. -, No. -
necessary changes were made to adapt the logistic aspects
of delivery room management for the second period.
Subsequently, each center was crossed over to the alternate
treatment for the period in which a second set of 50 patients
was enrolled. For the self-inflating bag period, each center
was assigned at random to use the bag either with or without
a PEEP valve, to allow subgroup analysis related to the use of
PEEP.
Delivery room management followed AAP/AHA and IL-
COR guidelines,4,13,14 and at least 1 person skilled in resusci-
tation attended every delivery. In addition, an assistant timed
and recorded the HR, actual maximum inspiratory pressure
used during ventilation, and other study variables until the
HR was stabilized. The self-inflating bag group received
PPV with a 300-mL self-inflating bag (Mark IV Baby;
Ambu, Ballerup, Denmark) with a manometer attached
visible to the provider. In centers randomly assigned to its
use, a PEEP valve was attached (PEEP 10; Ambu). The T-
piece group received PPV using a Neopuff T-piece resusci-
tator (Fisher & Paykel, Auckland, New Zealand) with a
PEEP valve.
Patients were initially ventilated with the following target
pressures: a positive inspiratory pressure of 25 cm H2O for
both devices, and a PEEP of 5 cm H2O when a PEEP valve
was used. The initial fraction of inspired oxygen (FiO2) was
0.4 for all infants up to September 2011, and 0.21 for term in-
fants ($37 weeks GA) and 0.4 for preterm infants
(<37 weeks GA) thereafter. FiO2 adjustments were deter-
mined by the attending physician. The following masks
were available at each delivery: silicon RD (Fisher & Paykel)
of various sizes, and Ambu 0A (Ambu). For both devices,
blended oxygen flow rate was set at 8 L/minute, and the
pop-off valve was set at 40 cm H2O. If the infant was intu-
bated in the delivery room, then PPV was provided with
the device assigned for that period. Each center subsequently
followed its usual practices.
Infants were followed until hospital discharge except in
cases of prolonged hospitalization. Infants of >32 weeks GA
were followed until 28 days postnatal age; those of
#32 weeks GA, until 36 weeks postmenstrual age.
Outcomes
The primary outcome measure was the proportion of infants
with an HR $100 bpm at 2 minutes after birth. This outcome
was chosen based on published data as a proxy for effective
response to resuscitation in the delivery room.4,15-17 All
time measurements were made from cord clamping by a
trained observer with a stopwatch. All centers used an early
cord clamping strategy throughout the study period. HR
was measured by pulse oximetry when possible or, alterna-
tively, with a stethoscope.
Each center used the pulse oximeter available in its delivery
room. The probe was placed immediately after birth on the
infant’s right wrist or hand before being connected to the ox-
imeter cable.4 Each pulse oximeter was set to the maximum
sensitivity and an averaging time of a 2-3 seconds.
- 2014 ORIGINAL ARTICLES

The secondary outcomes in the delivery room included Data Management and Monitoring
elapsed time to achievement of an HR $100 bpm, time to Data collection was done by an investigator in each center
initiation of spontaneous breathing, SpO2 at 2 minutes, pro- who was responsible for completing the case report forms.
portion of infants who were intubated after failure of PPV by A monitoring investigator audited and evaluated the study’s
mask, use of chest compressions and/or medications, Apgar progress through periodic visits to each center throughout
scores at 1 and 5 minutes, mortality rate, presence of air leaks the recruitment period. Data were entered in an electronic
(pneumothorax and pneumomediastinum), and maximum database designed for this study.
ventilation pressures and FiO2 administered. Subsequent sec-
ondary outcomes included the incidence of air leaks, use and Results
duration of oxygen administration, number of days on me-
chanical ventilation and/or continuous positive airway pres- The study was initiated with 14 centers. Three centers were
sure, incidence of hypoxic ischemic encephalopathy, and withdrawn because of difficulties in the recruitment strategy;
incidence of bronchopulmonary dysplasia (BPD), defined none of these completed the first stage of the study, and their
as oxygen supplementation at 36 weeks postmenstrual age patients were not included in the analysis. Between December
for newborns of <32 weeks GA or for more than 28 days in 2009 and August 2012, 1449 infants were eligible out of 54 891
those of $32 weeks GA. Mortality before hospital discharge born at the participating centers (2.6%). Of these 1449 infants,
was also included. 1032 were enrolled, and after 5 exclusions, 511 infants in the T-
piece group and 516 infants in the self-inflating bag group were
Sample Size and Statistical Analyses analyzed by intention to treat (Figure 1; available at www.jpeds.
It was initially estimated that approximately 5% of newborns com). Six centers were allocated to use the self-inflating bag
would require PPV for resuscitation at birth.1 A cluster with a PEEP valve and 5 centers used the self-inflating bag
design was chosen because it was considered ethically unac- without a PEEP valve. The duration of the washout period
ceptable to delay resuscitation to randomize patients individ- ranged from 14 days to 118 days.
ually. In addition, the need for resuscitation cannot always be Baseline characteristics of the 2 groups were comparable
anticipated, making it impossible to prepare the required except for the distribution of very low birth weight
team and equipment for each delivery with a potential need (VLBW) infants (Table I). Thus, we adjusted the results
for resuscitation.3 The allocation sequence for the randomi- not only by center, but also by birth weight <1500 g. The
zation was computer-generated by the study statistician. proportion of VLBW infants also differed among centers
The sample size for this cluster-randomized crossover (Figure 2; available at www.jpeds.com).
study with binary response was estimated using the formula There were no significant between-group differences in the
proposed by Hughes et al18 and confirmed by computer sim- primary outcome; an HR $100 at 2 minutes was achieved by
ulations. Assuming 50 patients for each center–period com- 479 infants (93.7%) in the T-piece group and by 466 infants
bination and a proportion of newborns with HR $100 bpm (90.3%) in the self-inflating bag group (OR, 0.65; 95% CI,
at 2 minutes after cord clamping of 0.8, for 80% power and a 0.41-1.05; P = .08). In 69% of the entire study population,
significance level of 0.05 (2-sided), at least 10 centers were HR was measured with a pulse oximeter; this proportion
needed to detect a difference of 0.1. This would be equivalent was similar in both groups. The main outcome was consistent
to 70% in the group ventilated with a self-inflating bag and among centers (Figure 3; available at www.jpeds.com).
80% in the group ventilated with a T-piece resuscitator based Eighty-six infants (17%) from the T-piece group and 134
on Dawson’s data.17 infants (26%) from the self-inflating bag group were intu-
An external Data and Safety Monitoring Committee car- bated in the delivery room (OR, 0.58; 95% CI, 0.4-0.8;
ried out 2 planned interim analyses after the inclusion of P = .002). The mean
SD maximum positive inspiratory
25% and 50% of the estimated study population, to ensure
safety and evaluate the need to reestimate the sample size.
The principal investigators and clinicians were not informed Table I. Baseline characteristics of the enrolled patients
of partial results until study completion. After 22 months of
T-piece group SIB group
recruitment, to prevent an unnecessary extension of the study Variable (n = 511) (n = 516) P value
without compromising its precision and power, the Data and Maternal age, y, mean
SD 28
7 28
7 .774
Safety Monitoring Committee recommended a reduction in Primiparity (n = 998), n (%) 220 (44) 239 (47) .320
the number of subjects per period in 2 centers that had Clinical chorioamnionitis, n (%) 26 (5) 28 (5) .810
Cesarean delivery, n (%) 262 (51) 290 (56) .108
started their recruitment late, because their slow enrollment Meconium-stained amniotic fluid 82 (16) 94 (18) .286
rate would have doubled the trial period without substan- (n = 1019), n (%)
tially increasing the power. Data were analyzed using SPSS Male sex, n (%) 303 (59) 298 (58) .616
GA, y, mean
SD 36
4.1 36
4.4 .539
version 17.0 (SPSS, Chicago, Illinois) and SAS version 9.2 Antenatal steroids, n (%) 142 (27) 156 (30) .405
for Windows (SAS Institute, Cary, North Carolina). Logistic Birth weight, g, mean
SD 2720
1025 2686
1069 .619
and linear regression mixed models were adjusted with the Birth weight >2500 g, n (%) 318 (62) 330 (64) .511
Birth weight <1500 g, n (%) 85 (17) 110 (21) .050
cluster effect as the random effect and treatment and birth
weight <1500 g as fixed effects. SIB, self-inflating bag.

Comparison of Devices for Newborn Ventilation in the Delivery Room 3

THE JOURNAL OF PEDIATRICS  www.jpeds.com Vol. -, No. -

Table II. Secondary outcomes

Outcome measure T-piece group (n = 511) SIB group (n = 516) OR (95% CI)* P value*
Outcomes in the delivery room
Intubation for ventilatory support in the delivery room, n (%) 86 (17) 134 (26) 0.58 (0.4-0.8) .002
1-min Apgar score #3, n (%) 153 (30) 177 (34) 1.3 (0.9-1.7) .070
5-min Apgar score #5, n %) 30 (6) 47 (9) 1.5 (0.9-2.5) .080
Drugs/chest compressions, n (%) 8 (1.6) 17 (3.3) 0.5 (0.2-1.1) .090
Time to spontaneous breathing, min, mean
SD† 2.7
36 3.05
3.9 - .100
Time elapsed until HR $ 100 bpm, min, median (IQR) 1 (0.5-1.6) 1 (0.5-1.8) - .068
Maximum PIP, mean
SDz variability 25.58
1.9 28
4.9 - <.001
PIP >25 cm H2O, n (%) 52 (10) 184 (37) 5.0 (3.6-7.0) <.001
Mean maximum FiO2 in delivery room, mean
SD 0.46
0.19 0.50
0.21 - .001
Outcomes after the delivery room
Mortality, n (%) 11 (2.2) 15 (2.9) 1.1 (0.5-2.5) .810
Air leaks (pneumothorax and/or pneumomediastinum), n (%) 13 (2.5) 8 (1.6) 0.6 (0.2-1.4) .250
Mechanical ventilation, n (%) 116 (22.7) 147 (28.5) 1.3 (0.9-1.8) .160
Days on mechanical ventilation, mean
SD 5.0
7.6 8.3
13.3 - .007
Days on CPAP, mean
SD 7.83
11.3 7.96
10.1 - .901
Hypoxic ischemic encephalopathy, n (%) 21 (4.1) 28 (5.4) 1.3 (0.7-2.4) .330
Use of oxygen, n (%) 208 (40.7) 222 (43.0) 1.1 (0.8-1.5) .411
Days on oxygen, mean
SD 13.8
17 22.8
25 - <.001

CPAP, continuous positive airway pressure; PIP, peak inspiratory pressure.

*Corrected by center and birth weight <1500 g.
†990 subjects.
z1007 subjects.

pressure delivered was 26
1.9 cm H2O in the T-piece group
vs 28
4.9 cm H2O in the self-inflating bag group (P < .001).
Air leaks, drug administration or chest compressions, mortal-
ity, and the use of mechanical ventilation did not differ signif-
icantly between the 2 groups (Table II). No deaths or air leaks
requiring treatment occurred in the delivery room. In the 704
infants (69%) with reliable pulse oximetry data at 2 minutes,
the mean SpO2 was 82%
14% for the T-piece group and
78%
20% for the self-inflating bag group (P = .004). The
FiO2 at that precise time was not registered.
After observing a trend toward an increased incidence of
BPD in the self-inflating bag group, we performed an explor-
atory analysis of the main outcomes in the subgroup of
VLBW infants. We found that 88% of VLBW infants in the
T-piece group and 76% of VLBW infants in the self-
inflating bag group achieved an HR $100 at 2 minutes
(P = .04). In addition, 25% of the T-piece group and 40%
of the self-inflating bag group developed BPD (P = .04)
(Table III).
We performed a subgroup analysis of the centers random-
ized to the self-inflating bag with a PEEP valve and those as-
signed to the use of self-inflating bag without a PEEP valve
and found results comparable to those from our analysis of
the whole cohort (Table IV). The distribution of the
recruited subjects by center is presented in Table V
(available at www.jpeds.com).
Discussion
In this large, pragmatic, multicenter study, there was no dif-
ference between the T-piece resuscitator and a self-inflating
bag for administering PPV with a face mask to achieve an
HR of $100 bpm at birth in newborns at $26 weeks GA.
However, the use of a T-piece significantly decreased the
intubation rate and the maximum pressure applied, as well
as the variability of maximum pressure.
In this trial, most infants responded appropriately with
either device, consistent with previous studies.2 This response
has been attributed to the Head paradoxical reflex, in which
inflation of the lung triggers an inspiratory effort.19 However,
a higher proportion of infants (both term and preterm

Table III. Analysis in the subgroup of VLBW infants

T-piece group SIB group
Outcome measure (n = 85) (n = 110) OR (95% CI)* P value*
HR $100 bpm at 2 min, n (%) 75 (88.2) 84 (76.4) 0.43 (0.19-0.95) .037
Intubation for ventilatory support, n (%) 45 (52.9) 76 (69.1) 2.01 (1.12-3.60) .019
Drugs/chest compressions, n (%) 3 (3.5) 5 (4.6) 1.30 (0.30-5.61) .723
Mechanical ventilation, n (%) 62 (72.9) 85 (77.3) 1.26 (0.66-2.43) .487
BPD, n (%) 21 (24.7) 44 (40.0) 2.03 (1.09-3.79) .036
Air leaks (pneumothorax and/or neumomediastinum), n (%) 3 (3.5) 2 (1.8) 0.51 (0.08-3.1) .461
Use of oxygen, n (%) 71 (83) 101 (92) 2.2 (0.9-5.5) .082
Days on oxygen, mean
SD 21
20 35
27 - .0007
*Corrected by center.

4 Szyld et al
- 2014 ORIGINAL ARTICLES

Table IV. Subgroup analysis comparing the patients from centers using SIB with PEEP and centers using SIB without
PEEP vs T-piece
T-piece SIB without PEEP valve T-piece SIB with PEEP valve
Outcome measure (n = 226) (n = 226) P value (n = 285) (n = 290) P value
Outcomes in the delivery room
HR $100 bpm at 2 min, n (%) 218 (96) 210 (93) .099 261 (92) 256 (88) .192
Intubation for ventilatory support in the delivery room, n (%) 31 (14) 53 (23) .008 55 (19) 81 (28) .012
1-min Apgar score #3, n (%) 51 (23) 66 (29) .092 102 (36) 111 (39) .340
5-min Apgar score #5, n (%) 12 (5) 23 (10) .055 18 (6) 24 (8) .364
Drugs/chest compressions, n (%) 2 (1) 6 (3) .175 6 (2) 11 (4) .239
Time to spontaneous breathing, min, mean
SD† 2.7
4.4 2.9
3.7 .668 2.7
2.8 3.2
4.1 .114
Time elapsed until HR $100 bpm, min, median (IQR) 1 (0.5-2) 1 (0.5-1.9) .109 1 (0.5-1.5) 1 (0.5-1.8) .247
Maximum PIP, mean
SDz variability 25.3
1.2 27.3
3.9 <.001 25.8
2.3 28.7
5.5 <.001
PIP >25 cm H2O, n (%) 11 (5) 73 (33) <.001 41 (15) 111 (40) <.001
Maximum FiO2 in delivery room, mean
SD 0.47
0.2 0.53
0.2 .005 0.46
0.2 0.48
0.2 .118
Outcomes after the delivery room
Mortality, n (%) 7 (3) 7 (3) .999 4 (1) 8 (3) .265
Air leaks (pneumothorax and/or pneumomediastinum), n (%) 6 (3) 2 (1) .175 7 (2) 6 (2) .759
Mechanical ventilation, n (%) 37 (16) 43 (19) .449 79 (28) 104 (36) .028
Days on mechanical ventilation, mean
SD 6
5 12
17 .014 5
8 7
11 .148
Days on CPAP, mean
SD 41
22 51
31 .030 88
49 86
37 .161
Hypoxic ischemic encephalopathy, n (%) 8 (4) 7 (3) .793 13 (5) 21 (7) .169
Use of oxygen, n (%) 93 (41) 96 (42) .079 115 (40) 126 (43) .321
Days on oxygen, mean
SD 13
15 23
22 .014 14
19 23
27 .012
Birth weight <1500 g, n (%) 30 (13) 41 (18) .146 55 (19) 69 (24) .180
BPD, n (%) 9 (30) 19 (46) .153 12 (22) 25 (36) .090

*Corrected by center and birth weight <1500 g.

†990 subjects.
z1007 subjects.

infants) in the self-inflating bag group was intubated for res-
piratory support. Animal studies have demonstrated that the
use of PEEP during resuscitation reduces the time to estab-
lishment of a functional residual capacity and improves gas
distribution in the lungs.20,21 Our findings may be partially
explained by the fact that a T-piece provides PEEP more
effectively than a self-inflating bag with a PEEP valve,
enhancing the clearance of fluid from the lungs and establish-
ment of an effective functional residual capacity.22,23 Analysis
of the VLBW infant subgroup revealed a higher incidence of
BPD in the self-inflating bag group.
Recognizing the limitations of the subgroup analysis,24 we
consider that some other differences observed between the
groups could contribute to these findings. BPD is a complex
disease associated with volutrauma and atelectrauma, among
other factors.25-28 In the self-inflating bag group, the average
maximum ventilation pressure applied to infants was signif-
icantly higher and highly variable; in addition, a greater pro-
portion of these infants received a pressure >25 cm of H2O.
These results are consistent with the findings of Dawson
et al12 and with those reported by us and others in studies
in mannequins.8,10,11 Furthermore, inconsistent PEEP or
the use of a self-inflating bag without PEEP also could have
contributed to a higher incidence of BPD in this subgroup
of VLBW infants. Finally, the mean number of days on oxy-
gen and days on mechanical ventilation were greater in the
self-inflating bag group.
These results should be interpreted with caution because
this was a secondary outcome with an insufficient sample
size to allow us to draw conclusions. Future studies targeted
to this subgroup of vulnerable infants may help better eluci-
date these findings.
Our study has several limitations. The trial could not be
blinded because its design precluded masking of the interven-
tion and the outcome evaluation. In addition, actual PEEP,
lung volumes, tidal volumes, and leaks around the mask
were not measured as recommended by some authors,
because this trial tested interventions in routine clinical prac-
tice.29,30 Moreover, use of the self-inflating bag with or
without a PEEP valve was not crossed over among centers,
making the analysis of its effect more difficult and less reli-
able. Also, we standardized the management only of the
initial minutes after birth, and thus some secondary out-
comes could have been influenced by the different modalities
of care provided by each center. Finally, we did not stratify by
birth weight, leading to differing proportions of infants with
birth weight <1500 g among the centers. However, this po-
tential source of bias is compensated for, at least in part, by
the nature of the crossover design, in which each center
included a similar number of subjects per group in consecu-
tive periods providing the same standard of care.
In summary, we found no difference between the T-piece
resuscitator and a self-inflating bag in administering PPV
with a face mask to achieve an HR of $100 bpm at birth in
newborns at $26 weeks GA. However, the use of a T-piece
significantly decreased the intubation rate and the maximum
pressure applied, as well as the variability of maximum pres-
sure. Our data support the use of T-piece resuscitators in the
delivery room when compressed gases are available. n
The authors gratefully acknowledge and thank all the patient’s fam-
ilies, the Chairs, and the staff of the participating centers. We are also
grateful to Susana Rodriguez, MD, Eduardo Bancalari, MD (holds
patent and license agreements with CareFusion), Fernando

Comparison of Devices for Newborn Ventilation in the Delivery Room 5

THE JOURNAL OF PEDIATRICS  www.jpeds.com
Rubinstein, MD, and Cecilia Rabasa, MD, for their participation as
members of the Data and Safety Monitoring Committee, and to
Eduardo Bergel, MD, Santiago Perez Lloret, MD, and Leandro Kova-
levsky, MSc, for statistical advice.
Submitted for publication Jul 30, 2013; last revision received Feb 3, 2014;
accepted Feb 18, 2014.

n para la Salud Materno
Reprint requests: Edgardo Szyld, MD, MSc, Fundacio
Infantil, Gavilan 1086, 1406 Buenos Aires, Argentina. E-mail: eszyld@gmail.com
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Appendix

Members of the Delivery Room Ventilation Devices Trial

Group include:
Argentina–Daniela Satragno, MD (Sanatorio de los Arcos,
Ciudad de Buenos Aires); Etelvina Soria, MD (Hospital Ma-
terno Infantil de Salta, Salta); Luis Ahumada, MD, Mirta Fer-
reyra, MD, and Adriana Mitrano, MD) Hospital
Misericordia, C
ordoba); Mar
ıa Carola Capelli, MD, and Ce-
cilia Cocucci, MD (Hospital Universitario Austral, Pcia de
Buenos Aires).
Chile–Paulina Toso, MD, and Miriam Faunes, RN (Uni-
versidad Cat
~ez, MD (Hos-
olica, Santiago); Viviana Veas Y
an
pital Dr. Gustavo Fricke, Vi~ na del Mar); Andr
es Rom
an
Navarro, MD (Hospital Dr. Hern
an Henr
ıquez Aravena, Te-
muco).
Peru–Tania Paredes Quiliche, MD, Wilber G
omez, MD,
Mar
ıa Mur, MD, and Juana Molina, RN (Instituto Nacional
Materno Perinatal, Lima).
Italy–Daniele Trevisanuto, MD, Nicoletta Doglioni, MD
(Universita di Padova, Azienda Ospedaliera di Padova).
US–Beau J. Batton, MD, Kara Weigler, RN (St. John’s
Children’s Hospital, Springfield, Illinois); Ricardo Rodri-
guez, MD, Firas Saker, MD, Lory Lewis, CNP, and John Dick-
son, RRT-NPS (Hillcrest Hospital, Cleveland Clinic,
Cleveland, OH).

Comparison of Devices for Newborn Ventilation in the Delivery Room 6.e1

THE JOURNAL OF PEDIATRICS  www.jpeds.com Vol. -, No. -

Figure 1. Flow diagram of the progress of patients through the study. SIB, self-inflating bag.

Figure 2. Distribution of birth weight <1500 g by center and period (n = 195; overall 19%).

6.e2 Szyld et al
- 2014 ORIGINAL ARTICLES

Figure 3. Proportion of infants with an HR $100 at 2 minutes.

Distribution by center, differentiating those assigned to the
self-inflating bag group with a PEEP valve or without a PEEP
valve.

Table V. Distribution of enrolled subjects by center

(n = 1032)
Number of subjects per center
Center Period 1 Period 2 Total
1 50 50 100
2 51 50 101
3 51 50 101
4 54 51 105
5 53 50 103
6 50 51 101
7 51 50 101
8 34 34 68
9 51 50 101
10 51 50 101
11 25 25 50

Comparison of Devices for Newborn Ventilation in the Delivery Room 6.e3