10.14639/0392-100X-N1277
Objective. Cleft lip palate (CLP) and cleft palate (CP) patients have a higher incidence of otitis media with effusion (OME) and conductive hearing problems. This article aims to evaluate the effectiveness of a 6-month course of self-administered autoinflation therapy in paediatric CP/CLP patients in terms of conductive hearing loss (CHL) and OME preva- lence.Methods. Fifty-one patients with surgically corrected CP/CLP and diagnosis of OME re- ceived indication to 6-months autoinflation therapy with an Otovent® device. Clinical evalu- ation, tympanogram and pure tone audiometry were carried out at the time of prescription (T0), at the end of treatment (T1) and at 6-month follow-up (T2). Patients were divided&nbsp;in 2 groups based on therapeutic compliance (29 compliant children, group A, vs 22 non-compliant children, group B).Results. Case series showed better audiological results and tympanometries at both time points (p &lt; 0.001). Group A showed better outcomes at tympanograms and at each frequen- cy, but were statistically significant only in terms of CHL at 250 and 1000 Hz frequencies at T1 (respectively 0.024 and 0.012).Conclusions. Nasal autoinflation therapy accelerates improvement of OME and hearing&nbsp;thresholds at short-/mid-term, leading to an earlier improved hearing performance.
text/xml
1827-675X
1277
en
Alberto Maria Saibene
http://creativecommons.org/licenses/by-nc-nd/4.0
ACTA Otorhinolaryngologica Italica
hearing loss
Nasal autoinflation devices for middle ear disease in cleft palate children: are they effective?
Text.Serial.Journal
https://www.actaitalica.it/
41
Audiology
2021-09-14
2020-11-27
2021-09-15
2021-09-15
364-370
1
Alberto Maria Saibene
2021/09/14
10.14639/0392-100X-N1277
364
Department of Otorhinolaryngology, Santi Paolo e Carlo Hospital, Department of Health Sciences, Università degli Studi di Milano, Milan, Italy
1827-675X
hearing loss
370
Nasal autoinflation devices for middle ear disease in cleft palate children: are they effective?
https://www.actaitalica.it/article/download/1277/656
41
ACTA OTORHINOLARYNGOLOGICA ITALICA 2021;41:364-370; doi: 10.14639/0392-100X-N1277




Audiology


Nasal autoinflation devices for middle ear disease
in cleft palate children: are they effective?
Dispositivi per ginnastica tubarica: efficacia nella patologia dell’orecchio medio
in palatoschisi
Cecilia Rosso, Antonia Pisani, Elisa Stefanoni, Carlotta Pipolo, Giovanni Felisati, Alberto Maria Saibene
Department of Otorhinolaryngology, Santi Paolo e Carlo Hospital, Department of Health Sciences, Università degli Studi di Milano,
Milan, Italy


SUMMARY
Objective. Cleft lip palate (CLP) and cleft palate (CP) patients have a higher incidence of
otitis media with effusion (OME) and conductive hearing problems. This article aims to
evaluate the effectiveness of a 6-month course of self-administered autoinflation therapy
in paediatric CP/CLP patients in terms of conductive hearing loss (CHL) and OME preva-
lence.
Methods. Fifty-one patients with surgically corrected CP/CLP and diagnosis of OME re-
ceived indication to 6-months autoinflation therapy with an Otovent® device. Clinical evalu-
ation, tympanogram and pure tone audiometry were carried out at the time of prescription
(T0), at the end of treatment (T1) and at 6-month follow-up (T2). Patients were divided
in 2 groups based on therapeutic compliance (29 compliant children, group A, vs 22 non-
compliant children, group B).
Results. Case series showed better audiological results and tympanometries at both time
points (p < 0.001). Group A showed better outcomes at tympanograms and at each frequen-           Received: November 27, 2020
cy, but were statistically significant only in terms of CHL at 250 and 1000 Hz frequencies        Accepted: March 1, 2021
at T1 (respectively 0.024 and 0.012).
Conclusions. Nasal autoinflation therapy accelerates improvement of OME and hearing               Correspondence
thresholds at short-/mid-term, leading to an earlier improved hearing performance.                Cecilia Rosso
                                                                                                  Department of Otorhinolaryngology, San Paolo
KEY WORDS: cleft, OME, nasal autoinflation, otovent, hearing loss                                 Hospital, University of Milan, Milan, Italy
                                                                                                  E-mail: rosso.cecilia1@gmail.com
RIASSUNTO
Obiettivo. I pazienti con labiopalatoschisi (CLP) e palatoschisi (CP) hanno una maggiore          Funding
incidenza di deficit uditivi conduttivi e di otite media con versamento (OME). Questo ar-         None.
ticolo valuta l’efficacia di un ciclo di 6 mesi di terapia di autoinsufflazioni con dispositivo
Otovent in pazienti CP/CLP in termini di ipoacusia conduttiva (CHL) e prevalenza di OME.          Conflict of interest
                                                                                                  The Authors declare no conflict of interest.
Metodi. Cinquantuno pazienti CP/CLP con diagnosi di OME hanno eseguito terapia do-
miciliare di autoinsufflazione di 6 mesi con il dispositivo Otovent®. Valutazione clinica,
timpanogramma ed esame audiometrico tonale sono stati effettuati al momento della pre-              How to cite this article: Rosso C, Pisani A,
scrizione, alla fine del trattamento e al follow-up post-trattamento di 6 mesi. I pazienti          Stefanoni E, et al. Nasal autoinflation de-
sono stati divisi in 2 gruppi in base alla compliance terapeutica (29 pazienti gruppo A vs          vices for middle ear disease in cleft palate
22 gruppo B).                                                                                       children: are they effective? Acta Otorhi-
Risultati. L’intero gruppo di pazienti ha mostrato miglioramenti audiologici e timpanome-           nolaryngol Ital 2021;41:364-370. https://doi.
                                                                                                    org/10.14639/0392-100X-N1277
trici a T1 e T2 (p < 0,001). Il Gruppo A ha mostrato risultati migliori ad ogni end-point,
statisticamente significativi solo per CHL alle frequenze 250 e 1000 Hz a T1 (rispettiva-
                                                                                                  © Società Italiana di Otorinolaringoiatria
mente 0,024 e 0,012).                                                                             e Chirurgia Cervico-Facciale
Conclusioni. La terapia con Otovent accelera il miglioramento dei pazienti CP/CLP con
disfunzioni dell’orecchio medio in termini di risultati impedenzometrici e CHL a breve-
                                                                                                                 OPEN ACCESS
medio termine.
                                                                                                  This is an open access article distributed in accordance with
PAROLE CHIAVE: palatoschisi, otite media effusiva, deficit uditivo trasmissivo, auto-             the CC-BY-NC-ND (Creative Commons Attribution-Non-
insufflazioni nasale, Otovent®                                                                    Commercial-NoDerivatives 4.0 International) license. The
                                                                                                  article can be used by giving appropriate credit and mentio-
                                                                                                  ning the license, but only for non-commercial purposes and
                                                                                                  only in the original version. For further information: https://
                                                                                                  creativecommons.org/licenses/by-nc-nd/4.0/deed.en




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                                                                                                Autoinflation devices for cleft children




Introduction                                                      tive study aims to evaluate the results of NBAI for the treat-
                                                                  ment of OME in paediatric CLP patients.
Orofacial clefts (OFC) represent a group of congenital
anomalies with incomplete closure of lips and/or palate
along the midline during intrauterine development. As is          Materials and methods
widely known, OFC may lead to feeding, speech, denti-             We conducted a prospective interventional study evaluat-
tion and conductive hearing disorders 1. Focusing on the          ing the efficacy of 6 months of home NBAI therapy in CLP
latter, children suffering from cleft (lip) palate (CLP) have     children. The Internal Review Board of the Santi Paolo e
a known susceptibility to otitis media with effusion (OME),       Carlo Hospital reviewed and approved the research. Pa-
mostly due to altered muscle function of the tensor veli          tients’ parents or caregivers gave their informed consent to
palatini 2. Despite the lack of conclusive data, studies fo-      the medical procedures described in the study.
cusing on paediatric CLP patients report that up to 91.1%         Inclusion criteria for the study were as follows:
of the CLP population have at least one episode of OME            • personal history of surgically treated cleft-lip palate
during the first 2 years of life, which is significantly higher      (CLP), cleft palate (CP), or submucosal palate cleft
than the 19% prevalence found in non-OFC pre-school                  (SPC);
children 3-6.                                                     • age between 3 and 13 years old;
Even the usual decreasing trend in OME prevalence during          • diagnosis of OME defined as type B tympanometry with
growth, which drops to about 10% in school-age children,             evidence of middle ear effusion at otoendoscopy at time
is less prominent in CLP children than in the normal popu-           of enrollment (at least one ear);
lation 7,8.                                                       Exclusion criteria for the study were as follows:
During recent years, attention to hearing problems in CLP         • incomplete cleft surgical correction;
patients has increased, acknowledging that middle ear ef-         • other otological comorbidities: sensorineural hearing
fusion and consequent hearing loss may lead to learning              loss, tympanic membrane perforation, acute otitis me-
issues, speech development problems and even irreversible            dia, or upper respiratory tract infections at the time of
middle ear complications 1. Persisting OME during child-             evaluation, cholesteatoma;
hood may indeed lead to sequelae during adolescence and           • CP/CLP/SPC in the context of other syndromes (e.g.
adulthood, such as conductive and/or mixed hearing loss,             Pierre-Robin sequence);
tympanic membrane retraction and chronic otitis media 7.          • rapid maxillary expansion planned during NBAI treat-
To avoid otological complications, ear, nose and throat spe-         ment;
cialists (ENT) strive to treat OME at the earliest stage in       • patients lacking sufficient cooperation to perform NBAI;
CLP patients. Management also varies depending on se-             • history of other ENT procedures related to OME such
verity and comorbidities and consists of both invasive and           as myringocentesis, grommets placement and adenoid-
non-invasive procedures 9. Grommets placement is among               ectomy preceding or concurring with NBAI;
the most used treatments and represents an invasive albeit        • failure to complete at least 1 year of follow up.
efficient technique 10. Among non-invasive therapies, nasal       Seventy-two consecutive patients with surgically corrected
balloon autoinflation (NBAI) is a well-known treatment            CLP who attended our Paediatric Otorhinolaryngological
that allows home therapy with no need for medical moni-           Unit in the last 2 years (1 April 2018 - 1 April 2020) for
toring at each session 11. After initial presentation from        either a first otolaryngological examination or during oto-
the ENT, only a few children require logopaedic support           laryngological follow-up fulfilled inclusion criteria.
to properly use the device 4. NBAI forces Eustachian tube         Ten patients were excluded for evidence of otological
opening via nasopharynx pressure increase, allowing for           comorbidities: 3 sensorineural hearing loss, 5 tympanic
drainage of middle ear fluid.                                     membrane perforations and 2 acute upper respiratory tract
Literature studies available on NBAI point towards the            infections at the time of evaluation. Two children with con-
overall effectiveness of these devices in the paediatric          current syndromes were excluded. One patient under rapid
population: it is now validated by systematic reviews and         maxillary expansion was excluded; 3 children underwent
international consensus conferences in which, among other         myringocentesis, 1 had grommet placement and 4 under-
things, it is defined as “the only beneficial, low-risk and       went adenoidectomy before or during NBAI.
low-cost non-surgical therapy” 12-14.                             All 51 patients included in our study had a clinical indica-
Nevertheless, to our knowledge, no authors have validated         tion for NBAI domiciliary therapy with a disposable bal-
the use of NBAI in CLP patients, a population with a high         loon device (Otovent®, Lofarma, Milan, Italy) along with
risk of OME and other middle ear diseases. This prospec-          nasal washes and underwent the same evaluation protocol.



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The protocol consists of otoendoscopy with ear wax re-            indicated that data concerning audiometric thresholds did
moval and otoendoscopy, tympanometric test and audio-             not follow a normal distribution (T0 p = 0.008; T1 and T2
metric exam at each time point: baseline (T0), 6-month            p < 0.001), we chose to use non-parametric tests for all
follow-up (T1) and at 1-year follow-up (T2). Audiometric          parameters, comparing T0, T1 and T2 results by variance
test was performed according to the age of the patient (con-      analysis with Friedman Test for related samples. Audio-
ditioned play audiometry with patients aged 3-6 years old         metric and tympanometric results at each time point (T0,
and pure tone audiometry with children older than 3 years)        T1 and T2) between Group A and B were analysed with
with Piano audiometer (Inventis Biomedica, Milan, Italy).         the Mann-Whitney test for unpaired samples. Descriptive
Hearing loss was defined taking into account the follow-          statistics are therefore reported as median ± interquartile
ing frequencies with air and bone conduction: 250 Hz, 500         range unless otherwise stated.
Hz, 1000 Hz, 2000 Hz and 4000 Hz. A threshold equal to
or better than 20 dB was considered normal and data were          Results
recorded as air-bone gaps (CHL). Each side was evaluated,
and its data recorded independently.                              Fifty-one consecutive OFC patients were evaluated. Demo-
Tympanometric curves were evaluated with an A756 mid-             graphic results are summarised in Table I.
dle ear analyser (Inventis Biomedica, Milan, Italy) and           Analysis of the overall case series points towards a general
were classified as type A (with a middle ear pressure be-         improvement of CLP population during follow-up. The dif-
tween +200 and -99 mmH2O), type B (flat tympanometry)             ference between tympanometric results at T0, T1 and T2
and type C (with a middle ear pressure between -100 and           time points appears statistically significant (Wilcoxon test,
-400 mmH2O).                                                      p < 0.001). Comparison of CHL at each frequency evalu-
Autoinflation exercises were performed at home with the           ated between T0, T1 and T2 also demonstrated to be statisti-
Otovent® device. After the clinical indication, ENT and lo-       cally different (p < 0.001). Pairwise comparisons reported an
gopaedic specialists explained how to use the device along        overall improvement of CHL thresholds at each frequency
with illustrative video. Preliminary complimentary logo-          and a progressive shifting from B curves to C and A curves
paedic sessions were offered to all families to learn how to      at the tympanometric test from T0 to T1 evaluation and from
use the device and to improve chances of compliance.              T0 to T2 collection. No significant difference was reported
The therapeutic protocol consisted of 3 sessions per day,         between T1 and T2 evaluation points in terms of any audio-
3 inflations per nostril for each session. Patients were pre-     metric frequency or tympanometric results (Tab. II).
scribed to carry out the exercises for 6 months. Patients’        Twenty-nine children reported satisfactory compliance
caregivers were instructed to keep a daily diary evaluating
compliance and the number of sessions performed.
                                                                  Table I. Demographic data of CLP population included in the study.
Exercises allow tubaric rehabilitation through a nasal bal-
loon and consist of two phases: during the inflation phase the     Demographic data                                 No. of patients
balloon is inflated via one nostril; during the deflation phase    Gender             Male                                 18
the air flows out of the balloon and into the nostril. Both                           Female                               33
the passive inflation phase and the active deflation phase         Age                Median                                6
increase the pressure in the nasopharynx, opening the Eus-                            IQR                                   3
tachian tube and allowing drainage of middle ear fluid. If the     Cleft type         Clef palate                          20
applied pressure doesn’t achieve the one in the middle ear,                           Monolateral cleft lip-palate         16
inflation can be followed immediately after by swallowing                             Bilateral cleft lip-palate           14
to provide additional power to the Eustachian tube opening.                           Submucosal cleft                      1
Patients were then divided into 2 groups based on compli-          Logopaedic         Required                             16
ance. Group A was composed of compliant children (de-              aid                Not required                         35
fined as correctly performing at least 70% of prescribed           Compliance         Yes                                  29
exercises) and group B by non-compliant children. Statisti-                           No                                   22
cal analysis of tympanometric and audiometric results was          Critical           Weak parent/child                    15
performed between the two groups.                                  issues             collaboration
Data were analysed using SPSS Version 26.0 (IBM Cor-                                  Recurrent acute otitis               4
poration. Armonk, NY. US). Statistical tests were two-                                media
sided, and a p-value ≤ 0.05 was considered statistically                              Unable to inflate device             3
significant. Since the Kolmogorov-Smirnov normality test          IQR: inter-quartile range.




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Table II. Overall significance between the 3 time points and pairwise comparison of CHL in CLP population.
                             T0                           T1                           T2                Overall sign                            Pairwise comparison
                      Group A           Group B          Group A         Group B          Group A           Group B                         T0-T1        T0-T2        T1-T2
 250 Hz              15 (± 10)        17.5 (± 15)         10 (± 5)      15 (± 10)        7.5 (± 15)       12.5 (± 15)         < 0.001       < 0.001     < 0.001       0.454
 500 Hz             17.5 (± 15)        20 (± 10)         10 (± 10)     15 (± 13.5)      5 (± 13.75)        10 (± 15)          < 0.001       < 0.001     < 0.001       0.881
 1000 Hz             10 (± 10)         10 (± 15)           0 (± 5)     5 (± 12.5)       0 (± 8.75)         5 (± 15)           < 0.001       < 0.001     < 0.001         1
 2000 Hz             0 (± 10)          5 (± 15)          0 (± 3.75)      0 (± 5)        0 (± 3.75)          0 (± 5)           < 0.001        0.050       0.012          1
 4000 Hz             5 (± 15)         7.5 (± 15)         0 (± 3.75)     0 (± 10)           0 (± 5)        0 (± 12.5)          < 0.001        0.017       0.004          1
Significance level is 0.05, values of significance have been adapted in accordance to Bonferroni correction for multiple tests.



with the treatment (Group A), while 22 patients did not                                        with satisfactory compliance was also carried out with the
reach sufficient adherence to the protocol according to car-                                   Mann-Whitney test. Analysis showed no significant differ-
egivers’ daily diaries (Group B).                                                              ences between the 2 types of clefts at each time point (Tab.
More specifically, group B registered a median of 17%                                          IV).
of the entire number of exercises prescribed per month                                         Mann-Whitney test was also used to compare CHL and
(interquartile range ± 7, minimum 2%, maximum 30%).                                            tympanometric results between the two age ranges (Group
Causes of non-compliance were: weak parental/patient col-                                      I: 3-6 years old, Group II: 7-13 years old) to investigate
laboration, recurrent acute otitis media which precluded the                                   whether age affects results: analysis revealed no significant
possibility of practicing NBAI exercises, impossibility to                                     difference between the two groups.
achieve an adequate pressure change despite the efforts and                                    Sixteen children (11 Group A, 5 Group B) underwent pre-
recurrent acute rhinosinusitis or other upper airway infec-                                    liminary logopedic sessions. Seven patients (5 Group A, 2
tions during the treatment period.                                                             Group B) required additional treatment due to unsatisfac-
Median age in group A was 6 ± 4 years, while in Group B                                        tory results with autoinflation therapy at 1-year follow-up:
was 5.5 ± 2 years.                                                                             4 children underwent rapid maxillary expansion, 1 patient
Mann-Whitney test showed that Group A and Group B did                                          underwent grommet placement and 2 required hearing aid
not differ in terms of baseline characteristics (Tab. III). At                                 fitting. There were no children who chose to switch to sur-
T1, Group A showed better outcomes in terms of CHL at                                          gery at T1.
each frequency evaluated, as well as a higher shift towards
A and C curves at tympanograms (Tabs. III, IV). Never-
theless, the difference appears statistically significant only
                                                                                               Discussion
at 250 and 1000 Hz frequencies. T2 time point evaluation                                       CLP patients have a known higher rate of hearing problems
shows further improvements in terms of CHL thresholds                                          than the general population. The potential sequelae during
and tympanogram results although not statistically signifi-                                    adolescence and adult life of OME and related middle ear
cant (see Tab. III).                                                                           diseases, also in terms of cognitive development, highlights
Comparison between CP and CLP patients in Group A                                              the need of treating OME at the earliest stage possible.


Table III. Pairwise comparison between Group A and Group B at each time point T0, T1 and T2 with Mann-Whitney test.
                                                 T0                         T1                         T2                                         Pairwise comparison
 CHL                                               Group A       Group B          Group A         Group B         Group A         Group B       T0          T1          T2
 Median (± IQR)                    250 Hz         15 (± 10) 17.5 (± 15)          10 (± 5)        15 (± 10) 7.5 (± 15) 12.5 (± 15)              0.245       0.024      0.185
                                   500 Hz        17.5 (± 15) 20 (± 10)          10 (± 10)       15 (± 13.5) 5 (± 13.75) 10 (± 15)              0.265       0.090      0.248
                                  1000 Hz         10 (± 10)  10 (± 15)            0 (± 5)       5 (± 12.5) 0 (± 8.75)    5 (± 15)              0.365       0.012      0.408
                                  2000 Hz          0 (±10)    5 (± 15)          0 (± 3.75)        0 (± 5)   0 (± 3.75)    0 (± 5)              0.364       0.209      0.735
                                  4000 Hz         5 (± 15)   7.5 (± 15)         0 (± 3.75)       0 (± 10)      0 (± 5)  0 (± 12.5)             0.431       0.195      0.994
 Tympanogram                         A              1.7%        4.5%              20.7%           13.6%        37.9%      13.6%                0.669       0.565      0.554
                                     B             70.7%       79.5%              29.3%           38.6%        22.4%      43.2%
                                     C             27.6%       15.9%               50%            47.7%        39.7%      43.2%
Significance level is 0.05. IQR: inter-quartile range.




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Table IV. Pairwise comparison between CP and CLP patients in Group A at each time point T0, T1 and T2 with Mann-Whitney test.
                                          T0                              T1                             T2                   Pairwise comparison
 CHL                                          CP             CLP           CP            CLP            CP             CLP         T0      T1      T2
 Median (± IQR)           250 Hz          15 (± 10)      15 (± 11.25)   10 (± 7.8)     10 ( ±5)       0 (± 15)     10 (± 12.35)   0.190   0.144   0.250
                          500 Hz          15 (± 10)       20 (± 15)     10 (± 13)      10 (± 5)     59 (± 12.81)    7.5 (± 15)    0.129   0.101   0.161
                         1000 Hz          10 (± 5)        10 (± 10)       0 (± 5)    2.5 (± 6.25)    0 (± 7.92)      5 (± 10)     0.143   0.458   0.422
                         2000 Hz          0 (± 10)        2.5 (± 10)    0 (± 2.13)     0 (± 5)       0 (± 2.46)      0 (± 5)      0.112   0.210   0.148
                         4000 Hz          5 (± 15)         5 (± 15)     0 (± 2.39)     0 (± 5)       0 (± 4.57)      0 (± 5)      0.105   0.299    0.1
 Tympanogram                A               3.4%              0%          17.2%         20.6%          37.9%          32.4%       0.290   0.444   0.094
                            B              55.2%            73.5%         20.7%         32.4%          20.7%          20.6%
                            C              24.1%            26.5%         44.8%         47.1%          24.1%          47.1%
Significance level is 0.05. IQR: inter-quartile range.



Among possible therapies for OME in CLP patients, NBAI                               aged 4-11 years who underwent autoinflation or simple fol-
represents a low-cost and low-risk strategy, applicable to                           low-up. The group evaluated tympanograms results and ear-
the primary care setting with no need for daily monitor-                             related measures of quality of life, demonstrating that the use
ing 15. Its lack of invasiveness allows its use without prelim-                      of NBAI in young children with OME is feasible in primary
inary specialistic training, even if the latter may improve                          care and effective in both aspects examined 17.
compliance.                                                                          According to the literature, surgery with grommet inser-
Our study shows that NBAI speeds up auditory recovery                                tion appears to be the most effective treatment in persistent
in CLP patients with OME, in terms of CHL at the end                                 OME with recurrent acute otitis media (rAOM) 1. Never-
of therapy (T1), with better results than in non-compliant                           theless, long waiting times for grommet insertion are not
patients. On the other hand, at 6-month follow-up (T2), the                          unusual and treatment ends up being delayed 19. Bidarian-
improvement reported in both groups does not appear to be                            Moniri et al. undertook a crossover study on 45 patients
significant at all at any frequency (Tab. III). However, the                         suffering from OME and waiting for grommet surgery: pa-
Wilcoxon test on the overall case series points towards a                            tients underwent both NBAI treatment and simple follow-
general improvement in hearing thresholds and tympano-                               up. The device demonstrated efficiency in improving both
metric curves (Tab. II). These results highlight that NBAI                           middle-ear pressure and hearing thresholds in most chil-
is an effective method to accelerate hearing improvement                             dren after four weeks of treatment and avoided grommet
in the short term, across an overall gain that would be most                         surgery in 36 children 20.
probably reached by the patient anyway. The faster im-                               Moreover, a Cochrane review by Venekamp et al. on the ef-
provement in Group A is reported especially at low-mid                               fectiveness of grommets in children with rAOM is limited
frequencies (250 Hz: p = 0.024; 500 Hz: p = 0.90; 1000 Hz:                           to five randomised clinical trials: low to very low-quality
p = 0.012) which are those more affected by OME 16. This                             evidence suggests that children receiving grommets are
difference appears extremely important given that learning                           less likely to have AOM recurrences compared to those
and speech development is strictly connected to hearing,                             managed by active monitoring, but the effect is mod-
and the earlier that CLP children have satisfactory hear-                            est with around one fewer episode at 6 months and a less
ing, the earlier they can achieve better results comparable                          noticeable effect by 12 months. It also appears uncertain
to those of any other child.                                                         whether or not grommets are more effective than antibiotic
Accordingly, tympanometric curves showed a faster im-                                prophylaxis 21.
provement of middle ear function using NBAI, with a faster                           Some reviews have shown that grommets are beneficial to
shift from B curves (70.7% Group A vs 79.5% Group B at                               the recovery of hearing in children with cleft palate and
T0) to C (50% Group A vs 47.7% Group B) and A (20.7%                                 OME. Nevertheless, Kuo et al. stated that conclusions
Group A vs 13.6% Group B) at T1 (Tab. IV). T2 evaluation                             are based on underpowered cohort studies and very-low-
also confirmed a better outcome for the compliant group,                             strength evidence 22. Ponduri also noted that there is cur-
but with no significant difference between groups (Tab. III).                        rently insufficient evidence on which to base the clinical
Many studies have evaluated the effectiveness of NBAI                                practice of early routine grommet placement in children
therapy for OME in young healthy patients. Williamson et                             with cleft palate 23.
al. carried out a randomised controlled study of 320 children                        In this scenario, NBAI seems a valid option to accelerate



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clinical improvement with any invasive or delayed ap-            nosinusitis should limit its use to avoid ascending of mu-
proach. Vennik et al. explored parent and healthcare pro-        copurulent secretions towards the middle ear 4. Moreover,
fessional views and experiences of NBAI, concluding that         treatment options should be taken into account together
it is an acceptable, low-cost treatment option for children      with caregivers before the prescription in order to evalu-
with glue ear in primary care 15.                                ate whether the child is expected to be compliant with the
In contrast, Berkman et al. compared the benefits and harms      treatment plan 15.
of strategies currently in use for managing OME: based on        Provision of educational materials and demonstration of
two meta-analyses of two studies 24,25, NBAI did not show        the method are likely to promote uptake and compliance 15.
improvement in tympanometry and hearing levels at more           In fact, according to our analysis, among the 16 patients
than 1 month from treatment 26.                                  who underwent preliminary logopaedic sessions, 68.75%
To our knowledge, no studies are available about NBAI in         fell into the compliant group (Group A), while 31.25%
CLP patients suffering from OME. This paper is the first         showed non-adherence (Group B).
one analysing the real benefits and feasibility of NBAI in       NBAI complications are almost exceptional. A case report
accelerating the improvement process in middle ear status        about pneumocephalus and orbital emphysema associated
and hearing levels in the short- to mid-term. The group also     with NBAI in an adult patient is described. Their review of
carried out a statistical comparison between different types     the literature showed similar effects just in adult patients
of cleft (CP and CLP) revealing that there are no differ-        with skull base defects relating to cranial/sinus surgery or
ences between clefts in spontaneous development of hear-         tumours 27.
ing and tympanometric status as well as in NBAI therapy          Possible future developments could include a wider case
results (Tab. IV).                                               series with a case-control study.
The small statistical significance of compared groups may        International consensus conferences already highlight the
be explained by the small sample size. Moreover, it is essen-    role of nasal autoinflation as the only non-surgical treat-
tial to remember that CLP patients report a natural improve-     ment objectively effective for OME in the general paediatric
ment of middle ear diseases and in particular in OME dur-        population: other medical options (steroids, antibiotics, an-
ing growth, so they are meant to decrease the trend in OME       tihistamines, decongestants) failed to demonstrate an effect
prevalence whether they undergo therapy or not, as reported      on OME resolution, while still having side-effects and unfa-
in our analysis 7,8. The most obvious limitation of our work     vourable cost-effectiveness. Concerning surgery, grommets
is the control group. Since it was defined a posteriori, there   seem to be an appropriate treatment for non-cleft children
might be some intrinsic selection biases causing worse-per-      who have audiological impact with their OME until the con-
forming patients to be assigned to the non-compliant group       dition normalises, with a higher risk of complications than
(e.g. frequency of OMA episodes). Despite this design, the       those undergoing conservative treatments, the most common
limitation can be fully resolved only by further prospective     of which are eardrum retraction and tympanosclerosis 14. Ad-
study, and it should be noted that audiologic baseline charac-   enoidectomy should be considered in recurrent OME, for as-
teristics are not significantly different between groups A and   sociated nasal obstruction, or in older children 28.
B. Furthermore, the behaviour in the non-compliant group         Hearing problems in cleft patients remain less investigated
was sufficiently consistent, with extremely low adherence to     in terms of therapeutical alternatives. It would be interest-
therapy. A more inconsistent scenario among non-compliant        ing to expand those findings and to compare different types
children would have made group B an even less strong con-        of non-invasive or invasive treatments (NBAI, rapid maxil-
trol group for statistical purposes.                             lary expansion, grommet surgery and adenoidectomy) on
Despite these shortcomings, statistical analysis revealed        the CLP population and to evaluate the comparative effec-
that NBAI accelerates the natural improvement of hearing         tiveness of treatments.
thresholds, thus anticipating the achievement of a satisfac-
tory hearing, potentially increasing learning and speech de-
velopment. However, we did not include a control group
                                                                 Conclusions
to compare learning curves and speech evolution between          CLP patients are a group with a well-known higher rate
NBAI treatment and non-treated CLP patients.                     of diseases, including hearing problems and OME. NBAI
NBAI has restricted indications: it is useful in the case of     accelerates improvement of middle ear status and hear-
children older than 3 years old because younger patients         ing thresholds at short-mid-terms (6 months) in order to
would not be able to practice it satisfactorily. Acute recur-    achieve growing results more rapidly and comparable to
rent otitis media should also be excluded to avoid certain       those of other children in hearing, learning and speech de-
non-adherence to the treatment 4. Acute adenoiditis and rhi-     velopment.



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C. Rosso et al.




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