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Journal of Perinatology (2006) 26, 31–36
r 2006 Nature Publishing Group All rights reserved. 0743-8346/06 $30
ORIGINAL ARTICLEHood versus mask nebulization in infants with evolving
bronchopulmonary dysplasia in the neonatal intensive care unit
A Kugelman1, I Amirav2, F Mor1, A Riskin1 and D Bader11Department of Neonatology, Bnai Zion Medical Center, Haifa, Israel and 2Department of Pediatrics, R. Sieff Hospital, Safed,Bruce Rappaport Faculty of Medicine, Haifa, Israel
Objective: To compare infants’ discomfort, nursing-time and caregiver
Aerosol medications are commonly used in infants with
preference, and assess the clinical efficiency (as a secondary outcome) of
bronchopulmonary dysplasia (BPD).1,2 Most devices for
hood versus facemask nebulization in infants with evolving
administering aerosol medications to infants and neonates are
bronchopulmonary dysplasia (BPD) in the neonatal intensive care unit.
derived from those developed initially for delivery of asthma
Study Design: A prospective, open, randomized, controlled crossover
medications to adults and older children. Most of these devices were
clinical trial. In total, 10 infants with BPD who were on inhaled beta-
modified for use by infants simply by adding a small facemask
agonist bronchodilators and corticosteroids were randomly assigned to
covering the mouth and nose, which provides the interface between
receive their nebulized treatments either by a facemask, or by a hood for
aerosol generator and patient. For optimum therapy, the edge of the
2–3 days, and then crossover to receive the same treatments with the
mask must fit tightly to the infant’s face, and that may agitate the
other technique for another 2–3 days. Infants’ discomfort, nursing-time,
infant.3 It has been shown that with jet nebulization even a one cm
caregiver preference and clinical efficiency were compared.
gap between the mask and the face reduces the dose delivered by
Results: At baseline there was no significant clinical difference between
50%.4 The current practice in most Neonatal Intensive Care Units
the groups. Nurse-time required for administering the hood nebulization
(NICU) requires that the nurse will open the incubator, hold the
(mean±s.e.m.: 1.9±0.1 min) was significantly shorter than the time for
baby in a semiseated position and attach the mask to the infant’s
mask nebulization (12.0±0.6 min, P<0.0001). Infants’ discomfort score
face, during the entire nebulization period (Figure 1). This is an
was significantly lower (0.1±0.04) for hood versus mask nebulization
elaborate and time-consuming task for a busy nurse in the NICU.
(2.5±0.2, P<0.0001). Nurses and parents unequivocally preferred the
Thus, there is clearly a need to develop a more acceptable and
hood treatment. During both mask and hood nebulization therapies (2–3
patient friendly interfaces for improving aerosol delivery to infants.5,6
days) clinical efficiency was comparable. While both methods caused an
As no facemask is required and nothing touches the face, a
immediate (20 min post) clinical improvement, the immediate respiratory
hood interface should provide a logical and compelling, infant
assessment change score was significantly greater for the hood versus the
friendly alternative for delivering nebulized drugs to infants.
mask nebulization (0.62±0.27 versus 0.13±0.14, P<0.05).
Furthermore, oxygen is routinely given via hood to infants in theNICU. Amirav et al.7 recently demonstrated scintigraphically that
Conclusions: Nebulization of aerosolized medications in infants with
inhalation via hood in wheezy infants achieved a comparable lung
evolving BPD by hood was less time-consuming for caregivers and was
deposition of salbutamol to that of a conventional facemask.
much better tolerated by the infants while being at least as effective as the
We hypothesized that hood and mask nebulization would
provide a comparable clinical response, but that the hood would be
Journal of Perinatology (2006) 26, 31–36. doi:10.1038/sj.jp.7211434;
less time-consuming and better tolerated by the infants. The
present study was designed to evaluate infants’ discomfort, nursing-
Keywords: bronchopulmonary dysplasia; hood; inhalation; mask;
time and caregiver preference, and the clinical efficiency of hood
nebulization; neonatal intensive care unit
versus facemask nebulization of aerosolized medications in infantswith evolving BPD in the NICU.
Correspondence: Dr A Kugelman, Department of Neonatology, Bnai Zion Medical Center,
47 Golomb Street, Haifa 31048, Israel.
This study was a prospective, open, randomized controlled
E-mail: [email protected] 19 August 2005; accepted 8 November 2005; published online 8 December 2005
crossover clinical trial comparing treatment convenience for the
Hood versus mask nebulization in infants with BPD
Figure 1 Mask nebulisation, with nurses’ ‘hands-on’ the baby, in the incubator.
infant and the nurse and clinical outcomes of hood versus
incubator, and the mask was held firmly against the infant’s face
facemask nebulization of beta-agonist bronchodilators and inhaled
(Figure 1). The hood used a jet-inverted nebulizer and treatments
corticosteroids (ICS) in infants with evolving BPD.
were administered in an incubator or crib (Figure 2). All aerosol
Infants were randomly assigned to receive the first treatment
treatments were administered with the infants calm or asleep and
either by a jet nebulizer (Opti-Mist Nebulizer, Maersk Medical SA,
Reynosa, Mexico) with a facemask, or by a hood (Child-Hood,Baby’s Breath Ltd, Advanced Inhalation Technologies, Or-Akiva,
Israel) for a course of 2–3 days followed by 2–3 days of
Nebulization treatments were assigned by the attending
nebulization therapy with the other aerosol delivery system.
neonatologist. Beta agonist, Terbutaline Sulfate (Teva Pharm. Ind. Ltd, Petach-Tikva, Israel) respirator solution (1 ml ¼ 10 mg),
was inhaled three times a day. The nebulizer was charged
Spontaneously breathing premature infants with evolving BPD
with a dose of 2 mg (0.2 ml) in 2 ml of normal saline. ICS,
whose attending physician decided to treat them with inhaled beta-
Budesonide respules (Teva Pharm. Ind. Ltd, Petach-Tikva,
agonist bronchodilators or ICS were eligible to participate in the
Israel), 0.5 ml, suspension for inhalation (2 ml ¼ 1 mg) was added
study. Infants were recruited consecutively over a 12-month period.
to the morning and evening inhalations. The nebulizers were
BPD was diagnosed when the premature infants required oxygen to
operated by an oxygen cylinder at a flow rate of 5 l/min until the
achieve an oxygen saturation >92% at 36 weeks postconceptional
drug-solution was administered as indicated by nebulizer
age with compatible chest radiograph.8 The parents of all infants
signed a written informed consent form. The study was approved bythe Ethics Committee of Bnai-Zion Medical Center. Infants were
excluded from the study if they had cardiac disease or if they wereclinically unstable.
1. Discomfort score: infants were observed every minute during
each nebulization by the nurses. One point was scored for every
minute that the infant either cried or resisted the treatment for
For the facemask treatments, infants were held by the nurse in a
more than 20 s; a maximal score of 6 represented maximal
semiseated position with the neck slightly extended in the crib or
distress, whereas 0 represented no distress.7
Hood versus mask nebulization in infants with BPDA Kugelman et al
Figure 2 Hood nebulisation in the incubator.
2. Nurse-time: the specific time that the nurse was directly
course of nebulization therapy was based on a composite
occupied in preparing and administering the nebulization was
measure termed respiratory assessment change score
measured by a stopwatch operated by the nurse.
(RACS).9,10 This measure combines differences of RDAI and
3. Nurse/parent preference: nurses and parents were asked by a
respiratory rate. Respiratory rate difference was calculated by
written questionnaire if they had a preference, or no preference,
scoring 1 point for each five breaths difference (0 points scored
for either delivery method. This question was asked at the end
for a change smaller than five breaths).
To assess the effect of the 2–3 day course (mask or hoodnebulization three times a day) data were recorded on the
mornings before, and at the end of the course of each mode ofnebulization. The immediate short-term effect was evaluated
1. Clinical observations: Vital signs including respiratory rate,
once daily, before and 20 min after the morning inhalation.
heart rate, blood pressure, pulse oximetry oxygen saturationand oxygen requirements were recorded. All physical
examinations were performed by a senior neonatologist. A
Sample size calculations were based on previous data in infants
simple and objective validated score (respiratory distress
receiving bronchodilator treatment via conventional nebulizers for
assessment instrument (RDAI)) was used to score retractions
BPD.6 Based on these data we estimated that there would be a more
and wheeze: 0 for no wheeze or retractions; 1 for mild or
than 80% chance of detecting a 50% difference between the groups
‘present’ wheeze or retraction; and 3 for moderate to severe
(alpha ¼ 0.05) when sample size (n) is 10 patients for each mode
wheeze or retractions. The RDAI is the sum of the points given
for retraction and wheezing scores. This score was chosen since
Paired t test, two-sided, was used to compare the two modes of
these variables were found to be reliable for evaluating
nebulization before and after each treatment and before and after
wheezing infants9–11 and was adjusted for small premature
each course of therapy. The unpaired t test was used for evaluating
infants. The change in respiratory status before and after
the RACS score between both techniques. The Mann–Whitney U
inhalation and at the start and at the end of the 2–3 day
test and the Wilcoxon Rank Sum test were used as appropriate
Hood versus mask nebulization in infants with BPD
when selecting a nonparametric test. Data are presented as
Table 2 Clinical status prior to and at the end of the nebulization
mean±standard error of the mean (s.e.m.). Significance was set at
In total, 10 clinically stable infants with evolving BPD (six males,
four females) participated in the study. Their mean birth weight
was 898±56 g, gestational age was 26.9±0.4 weeks, study weight
was 1986±247 g, study age was 66±8 days, and postconceptional
age was 35.9±1.2 weeks. Apart from inhaled beta-agonist
bronchodilators and ICS, four infants received caffeine for apnea of
prematurity and seven received diuretics (hydrochlorothiazides and
spironolactone) for BPD during the study.
RR ¼ respiratory rate (breaths per minutes); HR ¼ heart rate (beats per minute);
Five infants started with hood and five with mask nebulization
BP ¼ mean blood pressure (mmHg); FiO2 ¼ fractional inspired oxygen concentration;
in random order. There was no significant clinical difference
SpO2 ¼ oxygen pulse oximetry (%); RS ¼ retraction score; WS ¼ wheezing score;RDAI ¼ respiratory distress assessment instrument; NS ¼ not significant.
between the groups at the start of each course of therapy witheither mode of nebulization (Table 1).
Nursing time required for treatment administration was
Table 3 Comparision of the change in clinical status from start to the
significantly shorter (1.9±0.1 versus 12.0±0.6 min, P<0.0001)
end of the nebulization course (2–3 days) between hood and mask
and discomfort score was significantly lower (0.1±0.04 versus
2.5±0.2, P<0.0001) for hood versus mask nebulization. All of thenurses (24) and 7/7 parents voted for the hood as their preferred
mode of nebulization when taking into account overall
convenience and the infants’ apparent comfort during therapy
(three parents did not have any preference as they were not
involved in the therapy in the nursery).
While during mask nebulization there was no significant
RR ¼ respiratory rate (breaths per minutes); RS ¼ retraction score; WS ¼ wheezing
change in RDAI, during hood nebulization the RDAI improved
score; RACS ¼ respiratory assessment change score; NS ¼ not significant.
significantly (Table 2). RACS from the start to the end of thenebulization course was comparable with both nebulizationtechniques (Table 3).
Table 4 Clinical status pre- and 20 min post nebulization
The immediate (20 min) clinical response to mask nebulization
was increased heart rate and improved RDAI (Table 4). Hoodnebulization resulted in a marked and less variable immediate
Table 1 Baseline clinical status prior to nebulization course
RR ¼ respiratory rate (breaths per minutes); HR ¼ heart rate (beats per minute);
BP ¼ mean blood pressure (mmHg); FiO2 ¼ fractional inspired oxygen concentration;
2 ¼ oxygen pulse oximetry (%); RS ¼ retraction score; WS ¼ wheezing score;
RDAI ¼ respiratory distress assessment instrument; NS ¼ not significant.
improvement in clinical respiratory variables (Table 4), which was
FiO2 ¼ fractional inspired oxygen concentration; SpO2 ¼ pulse oximetry oxygen
significantly greater than the response to mask nebulization
saturation (%); RDAI ¼ respiratory distress assessment instrument; NS ¼ notsignificant.
Hood versus mask nebulization in infants with BPDA Kugelman et al
Table 5 Comparison of the change in clinical status pre- and 20 min
facemask application. Irritation and agitation could greatly reduce
post nebulization between hood and mask nebulization
the drug delivery to the infant’s lungs and reduce treatmentefficiency.7,13,14 This could explain in part our findings of some
clinical advantage of hood versus mask nebulization. Infant’s
comfort plays an important role in growing premies. All efforts
should be made to decrease discomfort and stress. Avoiding stress
by using a more infant friendly nebulization technique may be
beneficial. Although subjective, all the nurses and caregiver parents
RR ¼ respiratory rate (breaths per minutes); RS ¼ retraction score; WS ¼ wheezing
unequivocally, chose the hood as their preferred mode of
score; RACS ¼ respiratory assesment change score; NS ¼ not significant.
nebulization when taking into account their convenience and theinfant’s comfort during therapy.
The study period spanned 50 days (2.5 days for each infant,
times 10 infants, times two for crossover). Each treatment with the
This is the first reported trial of hood nebulization in the NICU.
hood saved B10 min of nursing time. A simple calculation of the
Our pilot study showed that nebulization of aerosolized
total time saved for the nurses during the study (10 min, times
medications in infants with evolving BPD by hood was less time-
three daily inhalations, times 50 days) amounts to 1500 min or
consuming for caregivers and was much better tolerated by the
25 h. In these days with a shortage of intensive care staff, a limited
infants while being at least as effective as the conventional
budget and crowded nurseries this time saving would be of
We are aware that the effectiveness of beta-agonist
Overall, both methods had comparable clinical efficiency,
bronchodilators and ICS in the treatment of premature infants with
with advantage to hood nebulization in the short-term effects.
evolving BPD is much debated.1,2,8 Furthermore, the use of inhaled
The short-term (20 min) postinhalation effect was similar in
steroids is limited according to the new guidelines of the American
terms of no change in oxygen saturation and oxygen
Academy of Pediatrics.12 Our study was not designed to address the
requirements (Table 4). However, while both modes of therapy
rationale for and effectiveness of these medications. However, since
resulted in significant improvement in RDAI, this improvement
aerosol therapies are nevertheless used in many NICUs, we
was more consistent and significantly larger with the hood as
primarily focused on infants’ discomfort and the time spent by
compared to mask nebulization (Tables 4 and 5). At the end of the
nurses during both modes of aerosol therapy. At the same time,
2–3 days course of the treatment (intermediate-term), the
and as a secondary outcome, we undertook clinical measurements
clinical status of the infants remained unchanged with both
to evaluate the relative effectiveness of the two methods of
techniques in terms of oxygen saturation and oxygen requirements
(Table 2). At the end of the hood nebulization course the
The primary goal of our study was to compare the hood versus
infants showed improvement in physical examination as reflected
mask aerosol administration in terms of infants’ discomfort and
in the RDAIs. Yet, there was no significant difference between
nursing-time. It is known that achieving a good facemask seal may
the nebulization techniques when comparing the changes in
be difficult in many infants due to agitation and crying.3
the respiratory parameters (RACS) in the intermediate term
Furthermore, nebulizer treatments take about 10 to 15 min and
(Table 3). Our results are in accordance with the study of Amirav
since this is longer than most infants will tolerate, they become
et al.7 in 14 infants with mean age of 8 months, where lung
impatient and agitated while using a mask. In our study, the focus
deposition of hood and mask nebulization were comparable, and
was not on the nebulization time itself, but on the time required by
both treatments provided similar clinical benefits and side effects.
the nurse to administer the treatments. That time was significantly
We did not observe changes in oxygen saturation and oxygen
shorter with the hood compared to a mask. This difference was
requirements, and this may be related to our population that
simply due to the fact that the nurse was not required to hold the
had only mild BPD, and was relatively stable, or to the
mask during the entire nebulization time in order to ensure a good
effectiveness of the treatment that is debatable in infants with
seal with the infant’s face, or to keep the infant in a semisitting
BPD. In contrast to our study, Amirav et al.7 in a different
position. The infant’s discomfort score was significantly lower
population of wheezy infants, showed improved oxygen saturation,
during hood versus mask treatment. Similar findings of better
reduced respiratory rate and increased heart rate with both
tolerability were reported in wheezy infants.7 After mask
nebulization, heart rate increased significantly (Table 4). This
Although there is a tendency to move away from nebulizers
could suggest a more significant systemic effect, but as all the other
towards smaller pressurized metered dose inhalers (MDI) with
measures remained stable, the more plausible explanation is that it
holding chambers,8,15–17 these also require a tightly fitting
is another reflection of irritation and discomfort related to the
facemask interface, with all the problems noted above except for a
Hood versus mask nebulization in infants with BPD
considerable reduction in the time required to complete aerosol
Cole CH. Special problems in aerosol delivery: neonatal and pediatric
administration. Furthermore, it is still questionable if very small
considerations. Respir Care 2000; 45: 646–651.
preemies can effectively open the inspiratory valve when using
Fok TF, Monkman S, Dolovich M, Gray S, Coats G, Paes B et al. Efficiency
commerical valved spacers with MDIs and under these conditions it
of aerosol medication delivery from a metered dose inhaler versus jet
may be better to remove the valves altogether.18 In future studies,
nebuliser in infants with bronchopulmonary dysplasia. Pediatr Pulmonol
hood nebulization should be compared to MDIs and aerosol
Amirav I, Balanov I, Gorenberg M, Groshar D, Luder AS, Newhouse MT.
holding chambers with mask in these infants.
Nebulizer hood compared to mask in wheezy infants; aerosol therapy
The limitation of the present pilot study is that it was an open
without tears. Arch Dis Child 2003; 88: 719–723.
study (it is impossible to do a blinded study for the primary
Greenough A, Milner AD. Bronchopulmonary dysplasia. In: Arnold (ed).
outcome measure when comparing these two nebulization
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observer, thus interobserver variations were avoided. However, a
Klassen TP, Rowe PC, Suteliffe T, Ropp LJ, McDowell IW, Li MM.
single observer assessment in itself could be a source of a bias in
Randomized trial of albuterol in acute bronchiolitis. J Pediatr 1991; 118:
the clinical observations. Thus, we should be cautious in the
interpretation of the clinical advantages of the hood (the clinical
Lowell DI, Lister G, Von Koss H, MacCarthy P. Wheezing in infants: the
efficiency was only the secondary outcome measure in our study
response to epinephrine. Pediatrics 1987; 79: 939–945.
and we concluded that both methods had overall comparable
Bertrand P, Aranibar H, Castro E, Sanchez I. Efficiency of nebulized
clinical efficiency despite some advantages of the hood that
epinephrine versus salbutamol in hospitalized infants with bronchiolitis. Pediatr Pulmonol 2001; 31: 284–288.
Postnatal corticosteroids to treat or prevent chronic lung disease in
We conclude that nebulization of aerosolized medications in
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Tal A, Golan H, Grauer N, Aviram M, Albin D, Quastral MR. Deposition
the settings of NICU, these advantages are of considerable
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