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ABSTRACT: BACKGROUND: Invasive pulmonary aspergillosis (IPA) is a life-threatening complication in immunocompromised patients. Early diagnosis and therapy improves outcome. Assessment of galactomannan (GM) in bronchoalveolar lavage (BAL) fluid is a proposed tool to diagnose IPA. Little is known about the diagnostic value of BAL GM in children. MATERIALS AND METHODS: Retrospectively, 72 bronchoscopies were analyzed for GM in patients fulfilling the host factor criteria as defined by the EORTC/MSG. A cut-off index value GM of ≥0.5 was used. Clinical data, results of chest CT-scans and BAL cultures were collected. RESULTS: Sensitivity, specificity, PPV, and NPV of BAL GM for a diagnosis of proven and probable IPA (n = 41) were 82.4%, 87.5%, 82.4%, and 87.5% respectively. A significant relation was found for BAL GM and abnormal chest CT (P = 0.01). No significant relationship was observed between BAL Aspergillus sp. culture and chest CT (n = 47). BAL GM and serum GM correlated significantly. In 9 out of 12 patients classified as possible IPA, antifungal therapy was continued or started, despite a negative BAL GM. CONCLUSIONS: BAL GM test had good diagnostic value in children suspected of IPA. However, the decision to continue or start antifungal therapy was mainly determined by the clinical suspicion of IPA based on chest CT-outcome, serum GM index values and failure of antibiotic therapy. Pediatr Pulmonol. © 2012 Wiley Periodicals, Inc.
Pediatric Pulmonology 09/2012; · 2.53 Impact Factor
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ABSTRACT: To collect longitudinal data on lung function in the first year of life after extracorporeal membrane oxygenation and to evaluate relationships between lung function and perinatal factors. Longitudinal data on lung function in the first year of life after extracorporeal membrane oxygenation are lacking.
Prospective longitudinal cohort study.
Outpatient clinic of a tertiary level pediatric hospital.
The cohort consisted of 64 infants; 33 received extracorporeal membrane oxygenation for meconium aspiration syndrome, 14 for congenital diaphragmatic hernia, four for sepsis, six for persistent pulmonary hypertension of the neonate, and seven for respiratory distress syndrome of infancy. Evaluation was at 6 mos and 12 mos; 39 infants were evaluated at both time points .
None.
Functional residual capacity and forced expiratory flow at functional residual capacity were measured and expressed as z score. Mean (sem) functional residual capacities in z score were 0.0 (0.2) and 0.2 (0.2) at 6 mos and 12 mos, respectively. Mean (sem) forced expiratory flow was significantly below average (z score = 0) (p < .001) at 6 mos and 12 mos: -1.1 (0.1) and -1.2 (0.1), respectively. At 12 mos, infants with diaphragmatic hernia had a functional residual capacity significantly above normal: mean (sem) z score = 1.2 (0.5).
Infants treated with extracorporeal membrane oxygenation have normal lung volumes and stable forced expiratory flows within normal range, although below average, within the first year of life. There is reason to believe, therefore, that extracorporeal membrane oxygenation either ameliorates the harmful effects of mechanical ventilation or somehow preserves lung function in the very ill neonate.
Pediatric Critical Care Medicine 03/2011; 12(2):159-64. · 3.13 Impact Factor
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ABSTRACT: The Cystic Fibrosis Questionnaire (CFQ) is widely used in research as an instrument to measure quality of life in patients with cystic fibrosis (CF). In routine patient care however, measuring quality of life is still not implemented in guidelines. One of the reasons might be the lack of consensus on how to interpret CFQ scores of an individual patient, because appropriate reference data are lacking. The question which scores reflect normal functioning and which scores reflect clinically relevant problems is still unanswered. Moreover, there is no knowledge about how healthy children and adolescents report on their quality of life (on the CFQ). With regard to quality of life the effect of normal development should be taken into account, especially in childhood and adolescence. Therefore, it is important to gain more knowledge about how healthy children and adolescents report on their quality of life and if there are any difference in a healthy populations based on age or gender. Without these data we cannot adequately interpret the CFQ as a tool in clinical care to provide patient-tailored care. Therefore this study collected data of the CFQ in healthy children and adolescents with the aim to refer health status of CF youngsters to that of healthy peers.
The CFQ was completed by 478 healthy Dutch children and adolescents (aged 6-20) in a cross-sectional study.
The majority of healthy children (over 65%) did not reach maximum scores on most domains of the CFQ. Median CFQ-scores of healthy children and adolescents ranged from 67 to 100 (on a scale of 0-100) on the different CFQ-domains. Significant differences in quality of life exist among healthy children and adolescents, and these depend on age and gender.
Reference data of quality of life scores from a healthy population are essential for adequate interpretation of quality of life in young patients with CF. Clinicians should be aware that the perception of health-related quality of life is not as disease-specific as one might think and also relies on factors such as age, normal maturation and gender.
BMC Pediatrics 01/2011; 11:86. · 1.88 Impact Factor
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ABSTRACT: to systematically review all available studies that investigated the longitudinal relationships between the psychological characteristics of children and adolescents suffering from asthma and those of their caregivers, and the onset and course of the asthma.
relevant studies were identified using Medline, PubMed, and PsychINFO between 1970 and September 2009.
twenty studies matching inclusion criteria were reviewed. Six studies focused on child-specific psychological characteristics in relation to the onset and course of asthma. No compelling evidence was found for an association with asthma onset, but there was some evidence that the child's psychological characteristics can contribute to the subsequent course of asthma. Fourteen studies considered the effects of the psychological characteristics of the caregivers. Eleven studies found significant relationships between the psychological problems of caregivers and the subsequent onset and unfavorable course of the asthma in the child.
in pediatric asthma both the psychological characteristics of the affected children and their caregivers appear to contribute to the course and possibly also to the onset of the condition.
Patient Education and Counseling 01/2011; 82(1):11-9. · 2.31 Impact Factor
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ABSTRACT: Children with airway malacia often have protracted courses of airway infections, because dynamic airway collapse during coughing results in impaired mucociliary clearance. The aim of this study was to determine the effect of the mucolytic drug recombinant human deoxyribonuclease (rhDNase) on the recovery of respiratory symptoms in children with airway malacia and lower respiratory tract infection (LRTI).
In a randomized double-blind controlled clinical trial, 40 children with airway malacia and LRTI were randomly assigned to receive either 2.5 mg nebulized rhDNase or placebo twice daily for 2 weeks. The primary endpoint was the change in the cough diary score (CDS) (scale 0-5) from baseline to the second week of treatment. Secondary endpoints were VAS symptom scores for cough, dyspnea, and difficulty in expectorating sputum, need for an antibiotic course, and lung function data (FVC, FEV(1), FEF(75), R(int(e))).
There was no significant difference in the mean change in CDSs from baseline between the rhDNase group and the placebo group (mean difference for daytime 0.19 (95% CI -0.53 to 0.90); for nighttime 0.38 (95% CI -0.30 to 1.05). Proportions of patients requiring antibiotics, and the mean changes in symptom scores and lung function from baseline did not significantly differ between both groups.
Treatment with 2 weeks of nebulized rhDNase does not enhance recovery or reduce the need for antibiotics in children with airway malacia and LRTI. (Controlled-trials.com number, ISRCTN85366144).
Pediatric Pulmonology 09/2009; 44(10):962-9. · 2.53 Impact Factor
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ABSTRACT: Single and serial spirometric data are commonly compared with predicted values to assess pulmonary function and normal lung growth.
Do reference equations adequately describe pulmonary function in a population and in growing individuals?
We applied five sets of reference equations with appropriate age ranges to cross-sectional data of FEV(1), FVC, and FEV(1)/FVC from the United States, Estonia, and The Netherlands (1,487 boys and 1,340 girls, 6 to 18 years of age), and to serial measurements in Dutch (430 girls and 769 boys, 6 to 19 years of age) and in German and Austrian children (1,305 girls and 1,303 boys, 6 to 13 years of age).
Compared with reference equations from Polgar and Zapletal, cross-sectional FEV(1) and FVC declined between the ages of 6 and 12 and then increased, leading to a spurious change of up to 25% predicted; this pattern was most pronounced in boys. In cross-sectional data this trend was much weaker when using reference equations from Hankinson, Quanjer, and Stanojevic, and these equations provided a good fit from the age of 12 upward. In longitudinal data (i.e., within individuals), the trend was more pronounced for FEV(1) in boys than in girls. No set of equations provided a satisfactory fit in the lower limits of normal, but Hankinson and Stanojevic equations performed best.
Spirometric reference equations that use only height for predicting pulmonary function are unsuitable for describing the progression of pulmonary function. Those that incorporate height and age demonstrate some discrepancy with longitudinal data. Failure to take these spurious trends into account leads to significant errors in estimating the natural course of respiratory disease, in allocating patients to treatment groups, or in assessing long-term effects of drug intervention in school children and adolescents.
American Journal of Respiratory and Critical Care Medicine 11/2008; 178(12):1262-70. · 11.08 Impact Factor
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ABSTRACT: Background: Recent data on the yield of bronchoscopy in pediatric cystic fibrosis (CF) patients are lacking. Therapeutic bronchoscopic lavage with the mucolytic recombinant human deoxyribonuclease (rhDNase) has been used during CF bronchoscopies, but efficacy data are scarce.
Methods: A retrospective review of all bronchoscopies performed in pediatric CF patients in our hospital in the past 15 years.
Aims of the Study: To evaluate indications for and safety of bronchoscopy in pediatric CF patients, to describe the findings of bronchoscopy and the contribution of these findings to clinical management, and to evaluate the application of bronchoscopic lavage with rhDNase.
Results: Between 1992 and 2007, 66 bronchoscopies were performed in 48 CF patients (25 males) at a median (range) age of 8.3 (0.1 to 20.4) years. Indications for bronchoscopy were persistent atelectasis (42%), refractory symptoms (29%), need for microbiologic culture (11%), suspected anatomic abnormality (11%), and bronchial toilet (7%). Relevant new information with therapeutic consequences was obtained in 28 (42%) bronchoscopies, including a first Pseudomonas aeruginosa infection (n=3), infection with atypical mycobacteria (n=3), or Aspergillus fumigatus (n=5), and severe tracheo(broncho)malacia (n=4). In patients with atelectasis, rhDNase lavage was associated with improved chest radiograph scores and a transient decline in forced vital capacity. In 7 of 11 patients with refractory symptoms, lung function tended to improve after rhDNase lavage. No serious complications were observed after bronchoscopy and rhDNase lavage.
Conclusions: Bronchoscopy provides clinically relevant information in about 40% of these pediatric CF patients. Lavage with rhDNase seemed safe, and was associated with improved chest radiographs in patients with therapy resistant atelectasis.
Journal of Bronchology & Interventional Pulmonology. 09/2008; 15(4):240-246.
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ABSTRACT: Mucoactive agents are used to treat a variety of lung diseases involving impaired mucociliary clearance or mucus hypersecretion. The mucoactive agents studied most frequently are N-acetylcysteine (NAC), recombinant human DNase (rhDNase), and hypertonic saline. Studies on the efficacy of these have been mainly conducted in adults, and in patients with cystic fibrosis (CF). The exact role of mucoactive agents in children with non-CF lung disease is not well established. We present an overview of the current literature reporting clinical outcome measures of treatment with NAC, rhDNase, and hypertonic saline in children.
Pediatric Pulmonology 12/2007; 42(11):989-1001. · 2.53 Impact Factor
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Ruben Boogaard,
Anthon R Hulsmann,
Leoniek van Veen,
Anja A P H Vaessen-Verberne,
Yen Ni Yap,
Arwen J Sprij,
Govert Brinkhorst,
Barbara Sibbles,
Tom Hendriks,
Sander W W Feith,
Carsten R Lincke,
Annelies E Brandsma,
Paul L P Brand,
Wim C J Hop,
Matthijs de Hoog, Peter J F M Merkus
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ABSTRACT: Treatment of hospitalized infants with respiratory syncytial virus (RSV) bronchiolitis is mainly supportive. Bronchodilators and systemic steroids are often used but do not reduce the length of hospital stay. Because hypoxia and airways obstruction develop secondary to viscous mucus in infants with RSV bronchiolitis, and because free DNA is present in RSV mucus, we tested the efficacy of the mucolytic drug recombinant human deoxyribonuclease (rhDNase).
In a multicenter, randomized, double-blind, controlled clinical trial, 225 oxygen-dependent infants admitted to the hospital for RSV bronchiolitis were randomly assigned to receive 2.5 mg bid of nebulized rhDNase or placebo until discharge. The primary end point was length of hospital stay. Secondary end points were duration of supplemental oxygen, improvement in symptom score, and number of intensive care admissions.
There were no significant differences between the groups with regard to the length of hospital stay (p = 0.19) or the duration of supplemental oxygen (p = 0.07). The ratio (rhDNase/placebo) of geometric means of length of stay was 1.12 (95% confidence interval, 0.96 to 1.33); for the duration of supplemental oxygen, the ratio was 1.28 (95% confidence interval, 0.97 to 1.68). There were no significant differences in the rate of improvement of the symptom score or in the number of intensive care admissions.
Administration of rhDNase did not reduce the length of hospital stay or the duration of supplemental oxygen in oxygen-dependent infants with RSV bronchiolitis.
Chest 04/2007; 131(3):788-95. · 5.25 Impact Factor
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ABSTRACT: Guidelines for the measurement of fractional exhaled nitric oxide (FE(NO)) recommend refraining from lung function tests (LFT) and certain foods and beverages before performing FE(NO) measurements, as they may lead to transiently altered FE(NO) levels. Little is known of such factors in infants. The aim of the present study was to evaluate whether forced expiratory maneuvers, sedation, nasal contamination, and breastfeeding affect FE(NO) values in infants. FE(NO) was measured off-line during tidal breathing by means of a facemask covering nose and mouth. FE(NO) measurements were performed in 45 sedated infants (mean age 12.1 months) who underwent LFT because of airway diseases and in 83 unsedated healthy infants (mean age 4.3 months). In infants with airway diseases, no difference was found in FE(NO) values before and 5 min after LFT (n = 19 infants, p = 0.7) and FE(NO) values before sedation did not differ from FE(NO) values during sedation (n = 10 infants, p = 0.2). Oral FE(NO) values were significantly lower than mixed (nasal + oral) FE(NO) (n = 42 infants, p < 0.001). FE(NO) values before and 5 min after breastfeeding were not different (n = 11 healthy infants, p = 0.57). The short-term reproducibility in healthy infants (n = 54) was satisfactory (intraclass correlation coefficient = 0.94). We conclude that, in infants with airway diseases, LFT prior to FE(NO) measurement did not influence FE(NO) values and FE(NO) values did not change after sedation. Oral FE(NO) values were significantly lower than mixed (oral + nasal) FE(NO), and breastfeeding did not influence FE(NO). Short-term reproducibility in awake healthy infants was good.
Pediatric Allergy and Immunology 03/2007; 18(1):36-41. · 2.46 Impact Factor
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Transplantation 12/2006; 82(10):1386. · 4.00 Impact Factor
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ABSTRACT: Fractional exhaled nitric oxide (FE(NO)) levels are increased in children and adults with asthma, whereas low levels have been found in cystic fibrosis and primary ciliary dyskinesia. The aim of this study was to investigate whether FE(NO) measurements could distinguish between children below the age of 2 with different airway diseases. FE(NO) measurements were performed in 118 infants aged between 4.6 and 25.2 mo: 74 infants with recurrent wheezing (RW), 24 with bronchopulmonary dysplasia (BPD), and 20 with cystic fibrosis (CF). FE(NO) was measured also in 100 healthy controls aged between 1.1 and 7.7 mo. Geometric mean (95% confidence interval) FE(NO) values were 10.4 (9.1-12.0) parts per billion (ppb) in healthy infants, 18.6 (15.6-22.2) ppb in wheezy infants, 11.7 (8.2-16.8) ppb in BPD infants and 5.9 (3.4-10.1) ppb in CF infants. FE(NO) in wheezers was higher than in controls, BPD, and CF (p = 0.009, p = 0.038, and p < 0.001, respectively). Atopic wheezers showed higher FE(NO) than nonatopic wheezers (p = 0.04). CF infants had lower FE(NO) than healthy controls and BPD infants (p = 0.003 and p = 0.043, respectively). FE(NO) values in BPD and control infants were not different. We conclude that FE(NO) is helpful to differentiate various airway diseases already in the first 2 y of life.
Pediatric Research 11/2006; 60(4):461-5. · 2.70 Impact Factor
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ABSTRACT: During the analysis of interrupter resistance (R(int))-measurements, most authors reject post-interruption tracings based on the shape of the pressure-time and flow-time curves. However, objective criteria for rejection are lacking. We aimed to formulate explicit rejection criteria that correspond to eyeballing the curve pattern (daily practice), in order to simplify the analysis. Inter-observer agreement within and between both methods was studied. Results obtained with the developed rejection criteria were compared to those of current practice (eyeballing) using 54 measurements (807 interruptions) of children with severe neurological impairment. Inter-observer agreement on rejection was similar using the criteria or eyeballing (85.6% vs. 82.8%). Using the criteria, more individual interruptions were rejected (43.4% vs. 29.8% using eyeballing), while discarding total measurements (<5 remaining interruptions) was similar (9.2% vs. 7.4% using eyeballing). Results using only the criteria for pressure-time curves were comparable to eyeballing. Outcome values were comparable between any of the used rejection methods and not rejecting at all. In this first detailed study on rejection of post-interruption tracings, explicit rejection criteria were developed. None of the rejection methods influenced the outcome value relevantly. However, rejection criteria can contribute to the standardization of the R(int) technique and simplify decision-making in daily practice.
Pediatric Pulmonology 10/2006; 41(10):937-46. · 2.53 Impact Factor
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ABSTRACT: The evidence for effectiveness of currently used asthma medication for wheeze in young children is reviewed.
The management of the infant and preschool child with wheezing is complicated by the uncertainty with respect to the aetiology. Difficulties in defining phenotypes and objective outcome parameters combined with the transient nature of symptoms which often resolve spontaneously have confounded many therapeutic studies. Recent studies on the effect of pharmacotherapy in wheezing infants have tried to define a more homogeneous phenotype as well as make a selection of patients that are likely to respond to the studied drug. In addition, these studies have used lung function parameters and nitric oxide as one of the outcome measurements. Studies on the nature of inflammation and the development of airway remodelling in infants and young children are done to further define phenotypes.
Currently, there are no evidence-based guidelines and not even consensus statements on the right approach in pharmacological treatment of wheezing in infants and preschool children. The main issue still is the difficulty in coming to a correct diagnosis. Further studies are needed on the nature and the diagnostics of phenotypes and on the effect of early intervention.
Current opinion in pulmonary medicine 02/2006; 12(1):34-41. · 3.08 Impact Factor
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ABSTRACT: Airway malacia is present in a small proportion of wheezing infants. The usefulness of infant lung-function testing (ILFT) in ruling out malacia in wheezy infants is unknown. We assessed the predictive value of ILFT parameters for airway malacia diagnosed by flexible bronchoscopy. Thirty-two term infants (mean (SD) age, 11.0 (4.6) months) with chronic wheeze unresponsive to asthma treatment underwent ILFT prior to bronchoscopy. Functional residual capacity measured by plethysmograph (FRCp), maximal flow at FRC (V'max(FRC)), and tidal breathing parameters were obtained. Expiratory flow-volume curves were visually examined for tidal flow limitation. Malacia was observed during bronchoscopy in 20 infants. V'max(FRC) (Z-score) was significantly lower in the group with malacia as compared with the group without malacia. Lung-function measurements had a low negative predictive value and sensitivity. While flow limitation during tidal breathing was highly predictive and 100% specific for airway malacia, only half of the infants with malacia had tidal flow limitation. In this selected group of infants, routine lung function testing could not discriminate between infants with and without airway malacia. However, the presence of tidal flow limitation was 100% predictive and specific for airway malacia.
Pediatric Pulmonology 12/2005; 40(5):431-6. · 2.53 Impact Factor
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ABSTRACT: Congenital airway malacia is one of the few causes of irreversible airways obstruction in children, but the incidence in the general population is unknown. Severe airway malacia or malacia associated with specific syndromes is usually recognized and diagnosed early in infancy, but information about clinical features of children with primary malacia, often diagnosed only later in childhood, is scarce.
We analyzed all flexible bronchoscopies performed between 1997 and 2004 in the Sophia Children's Hospital, summarized clinical features of children with primary airway malacia, estimated the incidence of primary airway malacia, and calculated the predictive value of a clinical diagnosis of airway malacia by pediatric pulmonologists.
In a total of 512 bronchoscopies, airway malacia was diagnosed in 160 children (94 males) at a median age of 4.0 years (range, 0 to 17 years). Airway malacia was classified as primary in 136 children and secondary in 24 children. The incidence of primary airway malacia was estimated to be at least 1 in 2,100. When pediatric pulmonologists expected to find airway malacia (based on symptoms, history, and lung function) prior to bronchoscopy, this was correct in 74% of the cases. In 52% of the airway malacia diagnoses, the diagnosis was not suspected prior to bronchoscopy. Presenting clinical features of children with airway malacia were variable and atypical, showing considerable overlap with features of allergic asthma. Peak expiratory flow was more reduced than FEV(1).
Primary airway malacia is not rare in the general population, with an estimated incidence of at least 1 in 2,100 children. Airway malacia is difficult to recognize based on clinical features that show overlap with those of more common pulmonary diseases. We recommend bronchoscopy in patients with impaired exercise tolerance, recurrent lower airways infection, and therapy-resistant, irreversible, and/or atypical asthma to rule out airway malacia.
Chest 12/2005; 128(5):3391-7. · 5.25 Impact Factor
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American Journal of Respiratory and Critical Care Medicine 11/2005; 172(8):1058-9; author reply 1059. · 11.08 Impact Factor
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ABSTRACT: No evidence based treatment is available for atelectasis. We aimed to evaluate the clinical and radiologic changes in pediatric patients who received DNase for persistent atelectasis that could not be attributed to cardiovascular causes, and who were unresponsive to treatment with inhaled bronchodilators and physiotherapy.
All non-cystic fibrosis pediatric patients who received nebulised or endotracheally instilled DNase for atelectasis between 1998 and 2002, with and without mechanical ventilation, were analysed in a retrospective descriptive study. The endpoints were the blood pCO2, the heart rate, the respiratory rate, the FiO2 and the chest X-ray scores before and after treatment.
In 25 of 30 patients (median [range] age, 1.6 [0.1-11] years) who met inclusion criteria, paired data of at least three endpoints were available. All clinical parameters improved significantly within 2 hours (P < 0.01), except for the heart rate (P = 0.06). Chest X-ray scores improved significantly within 24 hours after DNase treatment (P < 0.001). Individual improvement was observed in 17 patients and no clinical change was observed in five patients. Temporary deterioration (n = 3) was associated with increased airway obstruction and desaturations. No other complications were observed.
After treatment with DNase for atelectasis of presumably infectious origin in non-cystic fibrosis pediatric patients, rapid clinical improvement was observed within 2 hours and radiologic improvement was documented within 24 hours in the large majority of children, and increased airway obstruction and ventilation-perfusion mismatch occurred in three children, possibly due to rapid mobilisation of mucus. DNase may be an effective treatment for infectious atelectasis in non-cystic fibrosis pediatric patients.
Critical care (London, England) 09/2005; 9(4):R351-6. · 4.61 Impact Factor
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ABSTRACT: The role of inhaled corticosteroids in the treatment of recurrent or persistent wheeze in infancy remains unclear. We evaluated the effect of 3 months of treatment with inhaled fluticasone propionate, 200 microg daily (FP200), on lung function and symptom scores in wheezy infants. Moreover, we evaluated whether infants with atopy and/or eczema respond better to FP200 as compared with non-atopic infants. Forced expiratory flow (Vmax(FRC)) was measured at baseline and after treatment. Sixty-five infants were randomized to receive FP200 or placebo, and 62 infants (mean age, 11.3 months) completed the study. Mean Vmax(FRC), expressed as a Z score, was significantly below normal at baseline and after treatment in both groups. The change from baseline of Vmax(FRC) was not different between the two treatment arms. After 6 weeks of treatment, and not after 13 weeks, the FP200 group had a significantly higher percentage of symptom-free days and a significant reduction in mean daily cough score compared with placebo. Separate analysis of treatment effect in infants with atopy or eczema showed no effect modification. We conclude that in wheezy infants, after 3 months of treatment with fluticasone, there was no improvement in lung function and no reduction in respiratory symptoms compared with placebo.
American Journal of Respiratory and Critical Care Medicine 03/2005; 171(4):328-33. · 11.08 Impact Factor
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Rebekka Veugelers,
Elsbeth A C Calis,
Corine Penning,
Arianne Verhagen,
Roos Bernsen,
Jan Bouquet,
Marc A Benninga, Peter J F M Merkus,
Hubertus G M Arets,
Dick Tibboel,
Heleen M Evenhuis
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ABSTRACT: In children with severe generalized cerebral palsy, pneumonias are a major health issue. Malnutrition, dysphagia, gastro-oesophageal reflux, impaired respiratory function and constipation are hypothesized risk factors. Still, no data are available on the relative contribution of these possible risk factors in the described population. This paper describes the initiation of a study in 194 children with severe generalized cerebral palsy, on the prevalence and on the impact of these hypothesized risk factors of recurrent pneumonias.
A nested case-control design with 18 months follow-up was chosen. Dysphagia, respiratory function and constipation will be assessed at baseline, malnutrition and gastro-oesophageal reflux at the end of the follow-up. The study population consists of a representative population sample of children with severe generalized cerebral palsy. Inclusion was done through care-centres in a predefined geographical area and not through hospitals. All measurements will be done on-site which sets high demands on all measurements. If these demands were not met in "gold standard" methods, other methods were chosen. Although the inclusion period was prolonged, the desired sample size of 300 children was not met. With a consent rate of 33%, nearly 10% of all eligible children in The Netherlands are included (n = 194). The study population is subtly different from the non-participants with regard to severity of dysphagia and prevalence rates of pneumonias and gastro-oesophageal reflux.
Ethical issues complicated the study design. Assessment of malnutrition and gastro-oesophageal reflux at baseline was considered unethical, since these conditions can be easily treated. Therefore, we postponed these diagnostics until the end of the follow-up. In order to include a representative sample, all eligible children in a predefined geographical area had to be contacted. To increase the consent rate, on-site measurements are of first choice, but timely inclusion is jeopardized. The initiation of this first study among children with severe neurological impairment led to specific, unexpected problems. Despite small differences between participants and non-participating children, our sample is as representative as can be expected from any population-based study and will provide important, new information to bring us further towards effective interventions to prevent pneumonias in this population.
BMC Pediatrics 02/2005; 5:25. · 1.88 Impact Factor
