Short term effects of adrenaline in bronchiolitis: a randomised controlled trial.

BACKGROUND: Airway narrowing in acute bronchiolitis does not respond to inhaled bronchodilators but does to adrenaline when compared to bronchodilators. Influences of supportive care were not considered in previous treatment studies. METHODS: Short term effects of nebulised adrenaline and saline placebo were compared in infants with moderately severe acute bronchiolitis. Thirty eight infants were recruited, 19 in each treatment group. After stabilisation, infants received a single 3 ml dose of either levo-adrenaline (3 mg) or 0.9% saline placebo via Pari-BABY nebuliser driven with 6 l/min oxygen for three minutes. Changes in respiratory rate (RR), heart rate (HR), oxygen saturation (SpO(2)), Respiratory Distress Assessment Instrument (RDAI), and activity levels were assessed at 20 minutes intervals at times -20, 0, 20, 40, and 60 minutes around treatment. Respiratory virology and chest x ray were performed. RESULTS: Supportive therapy prior to study treatment resulted in significant reductions in RR (by 4.3 breaths/min) and HR (by 4.6 beats/min); there were no changes in SpO(2) or RDAI. There were no further changes in any parameter in either treatment group at any assessment time after treatment. CONCLUSION: No improvement was shown with inhaled adrenaline in acute bronchiolitis, when compared with supportive care or placebo. Improvements noted pretreatment question whether prior noted improvements were through supportive care or pharmacological interventions.     

Short term effects of adrenaline in bronchiolitis: a randomised controlled trial

Background: Airway narrowing in acute bronchiolitis does not respond to inhaled bronchodilators but does to adrenaline when compared to bronchodilators. Influences of supportive care were not considered in previous treatment studies. Methods: Short term effects of nebulised adrenaline and saline placebo were compared in infants with moderately severe acute bronchiolitis. Thirty eight infants were recruited, 19 in each treatment group. After stabilisation, infants received a single 3 ml dose of either levo-adrenaline (3 mg) or 0.9% saline placebo via Pari-BABY nebuliser driven with 6 l/min oxygen for three minutes. Changes in respiratory rate (RR), heart rate (HR), oxygen saturation (SpO₂), Respiratory Distress Assessment Instrument (RDAI), and activity levels were assessed at 20 minutes intervals at times -20, 0, 20, 40, and 60 minutes around treatment. Respiratory virology and chest x ray were performed. Results: Supportive therapy prior to study treatment resulted in significant reductions in RR (by 4.3 breaths/min) and HR (by 4.6 beats/min); there were no changes in SpO₂ or RDAI. There were no further changes in any parameter in either treatment group at any assessment time after treatment. Conclusion: No improvement was shown with inhaled adrenaline in acute bronchiolitis, when compared with supportive care or placebo. Improvements noted pretreatment question whether prior noted improvements were through supportive care or pharmacological interventions.     

Antibiotic treatment of pneumonia and bronchiolitis. A prospective randomised study.

Routine administration of antibiotics in the treatment of pneumonia and bronchiolitis in infants and small children was evaluated in an open randomised prospective trial. From 1979-82 136 children between the age of 1 month and 6 years were allocated to one of two treatment groups shortly after their admission to a paediatric ward. Group A patients were to be given antibiotics but those in group B were not. None of the children had received antibiotics before hospital admission. A viral infection was diagnosed in 38 of the 72 patients from group A and in 34 of the 64 patients from group B. Respiratory syncytial virus was detected in 84% of these patients. Samples of tracheal secretions showed no differences between the groups in respect of cytology and bacterial flora. Nor were there any significant differences in the course of acute disease, the frequency of fever relapse and pulmonary complications. Fifteen patients from group B were subsequently treated with antibiotics: two of these developed secondary purulent infections of the middle ear and one showed a slight pleural effusion. These results do not support the routine use of antibiotics in infants and small children admitted to hospital with pneumonia and bronchiolitis.     

Oral salbutamol for symptomatic relief in mild bronchiolitis a double blind randomized placebo controlled trial

OBJECTIVES: To determine the efficacy of oral salbutamol for providing symptomatic relief in mild bronchiolitis. DESIGN: Randomized double-blind placebo controlled trial. SETTING: Pediatric Outpatient Department of a tertiary care hospital. SUBJECTS: 140 infants (of 310 approached) with a clinical diagnosis of acute bronchiolitis. I N T E R V E N T I O N : Oral salbutamol (0.1 mg/kg/dose) (n=70) or placebo (n=70) three times a day for 7 days or till complete resolution of symptoms, whichever was earlier. OUTCOME VARIABLES: Time for resolution of illness (ROI), duration of fever, cough, coryza, noisy breathing, time to achieve normal feeding and normal sleep, and frequency of hospitalization and adverse effects. RESUltS: Median (SE, 95% CI) duration of resolution of overall illness was similar in the two groups [6 (0, 5 to 7) d in the salbutamol group vs. 5 (1, 4 to 6) days in placebo group; P=0.21]. There was no significant difference in mean duration of fever, cough, coryza, noisy breathing, time to achieve normal feeding and normal sleep; and frequency of hospitalization or adverse effects, between the two groups. However, tremors were observed in 5 infants in the salbutamol group. CONCLUSION: Oral salbutamol is not superior to placebo in reducing the duration of symptoms in mild cases of acute bronchiolitis in children.     

Chest physiotherapy using passive expiratory techniques does not reduce bronchiolitis severity: a randomised controlled trial

Chest physiotherapy (CP) using passive expiratory manoeuvres is widely used in Western Europe for the treatment of bronchiolitis, despite lacking evidence for its efficacy. We undertook an open randomised trial to evaluate the effectiveness of CP in infants hospitalised for bronchiolitis by comparing the time to clinical stability, the daily improvement of a severity score and the occurrence of complications between patients with and without CP. Children <1 year admitted for bronchiolitis in a tertiary hospital during two consecutive respiratory syncytial virus seasons were randomised to group 1 with CP (prolonged slow expiratory technique, slow accelerated expiratory flow, rarely induced cough) or group 2 without CP. All children received standard care (rhinopharyngeal suctioning, minimal handling, oxygen for saturation ≥92%, fractionated meals). Ninety-nine eligible children (mean age, 3.9 months), 50 in group 1 and 49 in group 2, with similar baseline variables and clinical severity at admission. Time to clinical stability, assessed as primary outcome, was similar for both groups (2.9 ± 2.1 vs. 3.2 ± 2.8 days, P = 0.45). The rate of improvement of a clinical and respiratory score, defined as secondary outcome, only showed a slightly faster improvement of the respiratory score in the intervention group when including stethoacoustic properties (P = 0.044). Complications were rare but occurred more frequently, although not significantly (P = 0.21), in the control arm. In conclusion, this study shows the absence of effectiveness of CP using passive expiratory techniques in infants hospitalised for bronchiolitis. It seems justified to recommend against the routine use of CP in these patients.     

Inhaled salbutamol for wheezy infants: a randomised controlled trial.

BACKGROUND: Salbutamol is frequently used as a bronchodilator for infants who wheeze. Many single dose studies have questioned its effectiveness. AIMS: To investigate the response of wheezy infants to salbutamol over an extended time period in order to elucidate either symptomatic relief or a protective effect. METHODS: Eighty infants under 1 year, with persistent or recurrent wheeze and a personal or family history of atopy, were recruited to a randomised, double blind, cross over, placebo controlled trial. Salbutamol (200 microg three times daily) or placebo were administered regularly over two consecutive treatment periods of four weeks via a spacer and mask. Symptoms of wheeze and cough were recorded in a diary. At the end of the study pulmonary function tests were performed before and after salbutamol (400 microg). RESULTS: Forty eight infants completed the diary study; 40 infants underwent pulmonary function testing. No difference in mean daily symptom score was observed between the salbutamol and placebo periods. There was no difference in the number of symptom free days. Compliance and forced expiratory flows remained unchanged and resistance increased following salbutamol. There was no relation between the response measured by symptom score or pulmonary function in individual patients. CONCLUSION: In wheezy infants with an atopic background, there was no significant beneficial effect of salbutamol on either clinical symptoms or pulmonary function. Clinical effects could not be predicted from pulmonary function tests. Salbutamol cannot be recommended as the bronchodilator of choice in this age group.     

Inhaled salbutamol for wheezy infants: a randomised controlled trial

BACKGROUND—Salbutamol is frequently used as a bronchodilator for infants who wheeze. Many single dose studies have questioned its effectiveness.AIMS—To investigate the response of wheezy infants to salbutamol over an extended time period in order to elucidate either symptomatic relief or a protective effect.METHODS—Eighty infants under 1 year, with persistent or recurrent wheeze and a personal or family history of atopy, were recruited to a randomised, double blind, cross over, placebo controlled trial. Salbutamol (200 µg three times daily) or placebo were administered regularly over two consecutive treatment periods of four weeks via a spacer and mask. Symptoms of wheeze and cough were recorded in a diary. At the end of the study pulmonary function tests were performed before and after salbutamol (400 µg).RESULTS—Forty eight infants completed the diary study; 40 infants underwent pulmonary function testing. No difference in mean daily symptom score was observed between the salbutamol and placebo periods. There was no difference in the number of symptom free days. Compliance and forced expiratory flows remained unchanged and resistance increased following salbutamol. There was no relation between the response measured by symptom score or pulmonary function in individual patients.CONCLUSION—In wheezy infants with an atopic background, there was no significant beneficial effect of salbutamol on either clinical symptoms or pulmonary function. Clinical effects could not be predicted from pulmonary function tests. Salbutamol cannot be recommended as the bronchodilator of choice in this age group.     

Prednisolone versus dexamethasone in croup: a randomised equivalence trial.

BACKGROUND: Croup remains a common respiratory problem presenting to emergency departments. A single oral treatment of oral dexamethasone results in improved outcome. Prednisolone has similar pharmacokinetic properties and has a significant advantage in that it is commercially available in liquid preparations. OBJECTIVE: To ascertain whether a single oral dose of prednisolone was equivalent to a single oral dose of dexamethasone (matched for potency) in children with mild to moderate croup. DESIGN: A double blind, randomised, controlled equivalence trial. SETTING: Tertiary paediatric emergency department. Patients: 133 children aged 3 to 142 months presenting with mild to moderate croup. INTERVENTIONS: Children received either a single oral dose of dexamethasone 0.15 mg/kg or single oral dose of prednisolone 1 mg/kg. Outcome: The main outcome measure was unscheduled re-presentation to medical care as determined by telephone follow up at 7 to 10 days. Croup score, adrenaline (epinephrine) use, time spent in the emergency department, and duration of croup and viral symptoms were secondary outcome measures. RESULTS: Children treated with prednisolone were more likely to re-present: 19 of 65 children (29%) reattended medical care compared with 5 of 68 (7%) from the dexamethasone group. The confidence intervals around this 22% difference in outcome were 8% to 35%, outside the 0% to 7.5% range of equivalence. There were no significant differences in other outcome measures. CONCLUSION: A single oral dose of prednisolone is less effective than a single oral dose of dexamethasone in reducing unscheduled re-presentation to medical care in children with mild to moderate croup.     

Nurse management of intractable functional constipation: a randomised controlled trial.

AIMS: To evaluate the effectiveness of a nurse led clinic (NLC) compared with a consultant led paediatric gastroenterology clinic (PGC) in the management of chronic constipation. METHODS: Children (age 1-15 years) with functional constipation were randomised following a detailed medical assessment to follow up in either the NLC or PGC. An escalating algorithm of treatment was used as the basis of management in both the NLC and PGC. Main outcome measures were: time to cure at last visit or later confirmed by telephone; time to cure at last visit; and time to prematurely leaving the study. RESULTS: A total of 102 children were recruited, of whom 52 were randomly assigned to NLC and 50 to PGC. Outcome assessment showed that 34 children in the NLC and 25 children in the PGC were confirmed cured at their last visit or later confirmed by telephone. The median time to cure was 18.0 months in the NLC and 23.2 months in the PGC. The probability of being cured was estimated as 33% higher in the NLC compared to PGC (hazard ratio 1.33). Attending the NLC hastened time to cure by an estimated 18.4%. CONCLUSION: Children who attend an NLC are equally as, if not more likely to be cured of intractable constipation, than those attending a PGC and on average their cure will occur sooner. Results suggest that an NLC can significantly improve follow up for children with intractable constipation and highlight the important role for clinic nurse specialists in management of children with gastrointestinal disease.     

Effects of probiotics on atopic dermatitis: a randomised controlled trial.

BACKGROUND: The aim of the study was to investigate the effects of probiotics on moderate or severe atopic dermatitis (AD) in young children. METHODS: Fifty six children aged 6-18 months with moderate or severe AD were recruited into a randomised double blind placebo controlled trial in Perth, Western Australia; 53 children completed the study. The children were given a probiotic (1x10(9)Lactobacillus fermentum VRI-033 PCC; Probiomics) or an equivalent volume of placebo, twice daily for 8 weeks. A final assessment at 16 weeks was performed. RESULTS: The main outcome measures were severity and extent of AD at the end of the study, as measured by the Severity Scoring of Atopic Dermatitis (SCORAD) index. The reduction in the SCORAD index over time was significant in the probiotic group (p = 0.03) but not the placebo group. Significantly more children receiving probiotics (n = 24, 92%) had a SCORAD index that was better than baseline at week 16 compared with the placebo group (n = 17, 63%) (p = 0.01). At the completion of the study more children in the probiotic group had mild AD (n = 14, 54%) compared to the placebo group (n = 8, 30%). CONCLUSION: Supplementation with probiotic L fermentum VRI-003 PCC is beneficial in improving the extent and severity of AD in young children with moderate or severe disease.     

Weaning preterm infants: a randomised controlled trial

OBJECTIVE: To assess the effect on growth and iron status in preterm infants of a specially devised weaning strategy compared with current best practices in infant feeding. The preterm weaning strategy recommended the early onset of weaning and the use of foods with a higher energy and protein content than standard milk formula, and foods that are rich sources of iron and zinc. Subjects and design: In a blinded, controlled study, 68 preterm infants (mean (SD) birth weight 1470 (430) g and mean (SD) gestational age 31.3 (2.9) weeks) were randomised to either the preterm weaning strategy group (n = 37) or a current best practice control group (n = 31), from hospital discharge until 1 year gestation corrected age (GCA). MAIN OUTCOME MEASURES: Weight, supine length, occipitofrontal head circumference, and intakes of energy, protein, and minerals were determined at 0, 6, and 12 months GCA. Levels of haemoglobin, serum iron, and serum ferritin were assayed at 0 and 6 months GCA. RESULTS: Significant positive effects of treatment included: greater increase in standard deviation length scores and length growth velocity; increased intake of energy, protein, and carbohydrate at 6 months GCA and iron at 12 months GCA; increased haemoglobin and serum iron levels at 6 months GCA. CONCLUSIONS: The preterm weaning strategy significantly influenced dietary intakes with consequent beneficial effects on growth in length and iron status. This strategy should be adopted as the basis of feeding guidelines for preterm infants after hospital discharge.     

An improved urine collection pad method: a randomised clinical trial.

AIM: To evaluate a modified urine collection pad (UCP) method for its ability to reduce heavy mixed growth bacterial contamination of UCP samples in young children with suspected urinary tract infection (UTI).Method: Febrile children under 2 years of age were randomised to two UCP METHODS: the same UCP kept in the nappy until urine was passed (single UCP group), or the UCP replaced with a fresh one every 30 minutes until urine was passed (replaced UCP group). In both groups a moisture sensitive audio alarm was used to signal passage of urine. RESULTS: Eighty children were enrolled and a satisfactory sample was obtained in 68 (37 in the single UCP group and 31 in the replaced UCP group). In 12 children (15%), collection failed, mainly because of faecal soiling of the pad. UTI occurred in three children (4%). In the remaining 65 samples, heavy mixed growth (> 10(5) organisms/ml) occurred in 1/31 (3%) in the replaced UCP group compared with 10/35 (29%) in the single UCP group (p = 0.008). There were no adverse effects from the use of the moisture sensitive audio alarm. CONCLUSION: Changing the UCP every 30 minutes almost eliminates heavy mixed growth contamination of UCP samples and substantially increases the proportion of UCP results that confidently exclude UTI. This represents a simple and clinically important improvement to the UCP method which is reliable for diagnosing and excluding UTI in young children still in nappies. It has potential for use in outpatient clinics, in the primary healthcare setting, or at home.