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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.
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We thank Dr Mike Newhouse for his critical review and suggestions.
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