Partially hydrolysed guar gum supplemented comminuted chicken diet in persistent diarrhoea: a randomised controlled trial.

BACKGROUND: Partially hydrolysed guar gum (Benefiber) added to a diet is fermented in the colon, producing short chain fatty acids, which improve intestinal function, including colonic salt and water absorption. AIMS: To evaluate the effect of Benefiber supplemented comminuted chicken diet in the treatment of persistent diarrhoea. METHODS: One hundred and sixteen children (aged 5-24 months), presenting to Dhaka Hospital with a history of watery diarrhoea for more than 14 days (persistent diarrhoea), were randomised to receive either: (1) comminuted chicken diet with Benefiber (study diet); or (2) comminuted chicken diet without Benefiber (control diet). The study period was seven days. RESULTS: Of 116 children, 57 received the study diet and 59 received the control diet. Diarrhoea resolved in a greater number of children with the study than with the control diet (46/55 (84%) v 36/58 (62%); odds ratio 3.12, 95% CI 1.19 to 8.4). Survival analysis for the duration of diarrhoea also showed a reduced duration of diarrhoea in children receiving the study diet. There was also a trend in daily stool reduction in children receiving the study diet, significant on days 4-7. CONCLUSION: Results show that Benefiber supplemented comminuted chicken diet enhances recovery of children with persistent diarrhoea, indicating its therapeutic potential.     

Trimethoprim-sulphamethoxazole in the treatment of persistent diarrhoea: a double blind placebo controlled clinical trial.

The efficacy of an absorbable antimicrobial agent trimethoprim-sulphamethoxazole (TMP-SMX) in the management of children with persistent diarrhoea was evaluated in a double blind, randomised, and placebo controlled trial. Of the 55 patients studied, 28 received TMP-SMX, and 27 received placebo. A trend in stool weight reduction was observed from the third day after the drug was started, and the reduction was statistically significant on day 6 and day 7. However, the difference in total stool output (g/kg) up to day 7 was not significantly different between the two groups. The proportion of children whose diarrhoea resolved by day 7 (therapeutic success) was significantly more in the treatment group compared with the placebo group (23 v 15). Additionally, mean duration of diarrhoea in the group that received TMP-SMX was less compared with the placebo group (6.0 v 8.3 days); this difference, however, was not significant. Hospital infection (probably nosocomial infection) was significantly less in the TMP-SMX treated group (1 v 10). The results of our study indicate that TMP-SMX has a clinical benefit in respect of reducing the stool output, and higher recovery rate within seven days of treatment. In addition, it prevented possible hospital acquired infection.     

Alanine- and glucose-based hypo-osmolar oral rehydration solution in infants with persistent diarrhoea: a controlled trial

To evaluate the efficacy of a hypo-osmolar and a standard (World Health Organization) oral rehydration salt (ORS) solution in persistent diarrhoea, a randomized controlled clinical trial was conducted in 55 children. After a 1-day observation period the children were assigned to one of three solutions: standard ORS (WHO-ORS) (osmolality 311 mosmol/1), hypo-osmolar ORS containing L-alanine and glucose (osmolality 255 mosmol/1) and iv polyelectrolyte solutions (osmolality 293 mosmol/1) for ongoing replacement of stool loss for the next 4 days. Excellent acceptability of ORS (101-160 ml/kg body weight/day) by the children was observed. There were no significant differences in the total intake of solutions and food, and frequency of stools among the groups Stool outputs were significantly less in infants receiving hypo-osmolar ORS than in those receiving WHO-ORS for 0-24h (p = 0.04), 0-48h (p = 0.01), 0-72h (p = 0.04) and 0-96h (p = 0.03). The results indicate a sufficient scope of ORS practice in persistent diarrhoea. Furthermore, we found that a hypo-osmolar ORS containing L-alanine and glucose is as efficacious as an iv solution and more effective than WHO-ORS for replacement of ongoing stool loss in persistent diarrhoea. Alanine-glucose ORS, hypo-osmolar solution, oral rehydration solution, persistent diarrhoea     

Efficacy of Lactobacillus rhamnosus GG in acute watery diarrhoea of Indian children: a randomised controlled trial

AIM: To evaluate the role of Lactobacillus rhamnosus GG (LGG) as probiotic in acute watery diarrhoea (AWD). SETTING: Hospital-based study. DESIGN: Randomised, controlled, blinded trial. PATIENTS AND METHOD: All patients of AWD (n = 684) admitted over 1-year period were invited to participate in the study as per predefined inclusion and exclusion criteria and were randomised to intervention and control groups. After adequate rehydration the intervention group (n = 330) received ORS with probiotic powder containing 60 million cells of LGG, while the control group (n = 332) received ORS alone twice daily for a minimum period of 7 days or till diarrhoea ceased. During the study period all patients received ORS and/or IV fluids for ongoing losses, and nutritional supplementation. None of them received any antibiotic or antidiarrhoeal medication. After exclusion of 16 patients, 646 (323 in each arm) patients completed the study. The daily frequency and total duration of diarrhoea and vomiting and the length of hospital stay were studied. Data were analysed by SPSS-10 software. Statistical significance was calculated by Student's t-test and chi2-test. RESULTS: Rotavirus was isolated in 75.85%. There was no significant difference between treatment groups in the daily frequency or duration of diarrhoea or vomiting or in the length of hospital stay. No complication was observed from the use of LGG. CONCLUSION: LGG supplementation does not decrease the frequency and duration of diarrhoea and vomiting in children with AWD, and does not reduce hospital stay in these patients.     

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.     

Hypotonic oral rehydration solution in acute diarrhoea: a controlled clinical trial

In a controlled trial, a hypotonic oral rehydration solution (ORS) (Na⁺67, K⁺20, CP66, citrate 7, glucose 89mmol/1 osmolality 249 mosmol/kg) was compared with a standard WHO-ORS (Na⁺90, K⁺20, Cl^-80, citrate 10, glucose lllmmol/1, osmolality 311 mosmol/kg) in 60 children aged 5-24 months with acute watery diarrhoea. In the hypotonic ORS group, stool frequency, proportion of children who vomited, ORS requirements and purging rate over 24-48 h were reduced by 33% ( p = 0.01), 30% ( p = 0.02), 21% ( p = 0.067) and 21% ( p = 0.03), respectively. The proportion of children who vomited and the purging rate over 48 h were reduced by 23% ( p = 0.03) and 10% ( p = 0.097), respectively. Serum electrolytes after 48 h were comparable. The beneficial effect of hypotonic ORS was most marked in, and largely contributed by, the subgroup negative for rotavirus.     

Hypo-osmolar oral rehydration salts solution in dehydrating persistent diarrhoea in children: double-blind, randomized, controlled clinical trial

A double-blind, randomized, controlled trial was conducted to compare the clinical efficacy of hypo-osmolar oral rehydration salts (ORS) solution (224 mmol/L) and standard ORS solution (311 mmol/L) in children with persistent diarrhoea who were prone to develop dehydration. Initially, 95 children aged between 3 and 24 mo were included in the study for overnight observation. Of these, 70 children who passed stool more than 2 g/kg/h were finally enrolled in the study and were randomly assigned either standard ORS or hypo-osmolar ORS. After decoding the identity of ORS, it was observed that 37 children were in the standard ORS group and 33 in the hypo-osmolar ORS group. Clinical parameters and microbiological findings of stool samples were comparable in the two groups at the time of enrolment. Total stool output (2.5 ± 1.1 vs 3.2 ± 1.6 kg; p = 0.04), duration of diarrhoea (114.8 ± 38.3 vs 145.4 ± 40.0 h; p = 0.002), total intake of ORS (5.4 ± 1.6 vs 7.8 ± 1.8 l; p = 0.002) and total fluid intake (7.9 ± 2.6 vs 10.0 ± 4.1 l, p = 0.01) were significantly less in the hypo-osmolar ORS group compared to the standard ORS group. However, the percentage of weight gain on recovery in the hypo-osmolar group was less compared to that of the standard ORS group, though the difference was statistically insignificant. Thirty-five (95%) children in the standard ORS and 33 (100%) children in the hypo-osmolar group recovered within 10 d of initiation of therapy and modified dietary management. Conclusion: Our findings suggest that hypo-osmolar ORS has beneficial effects on the clinical course of dehydrating persistent diarrhoea.     

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.     

Vitamin C supplementation in very preterm infants: a randomised controlled trial

OBJECTIVE: To determine whether regulating vitamin C (ascorbic acid: AA) intake to achieve higher or lower plasma concentrations was associated with improved clinical outcome. DESIGN: A double blind, randomised controlled trial. SETTING: Neonatal intensive care unit at Christchurch Women's Hospital. PATIENTS: Infants with birth weight <1500 g or gestation <32 weeks, admitted to the unit within 48 hours of birth. INTERVENTION: Infants were randomised to one of three protocols with regard to AA supplementation for the first 28 days of life: group LL received low supplementation throughout; group LH received low until day 10 and then high: group HH received high throughout. MAIN OUTCOME MEASURES: Primary outcome measures were oxygen requirement at 28 days and 36 weeks postmenstrual age, total days supplemental oxygen, and retinopathy of prematurity. AA concentrations were measured at study entry (day 2), and days 10, 21, and 28. RESULTS: A total of 119 infants were enrolled over 24 months (mean gestation 28.4 weeks; birth weight 1161 g). Six infants died, and these had significantly higher AA concentrations before randomisation than surviving infants (116 micromol/l (95% confidence interval 90 to 142) v 51 micromol/l (45 to 58), p<0.0001). There were no significant differences in primary outcomes between the groups. However, the proportion of surviving infants with an oxygen requirement at 36 weeks postmenstrual age in group HH (19%) was half that in group LL (41%) (p=0.06). CONCLUSIONS: In a randomised controlled trial, no significant benefits or harmful effects were associated with treatment allocation to higher or lower AA supplementation throughout the first 28 days of life.     

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.     

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.     

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.     

Nebulised amiloride in respiratory exacerbations of cystic fibrosis: a randomised controlled trial

OBJECTIVE: To assess the benefit of nebulised amiloride added to the standard inpatient treatment of a respiratory exacerbation in cystic fibrosis. DESIGN: Prospective, randomised, double blind, placebo controlled trial. SUBJECTS: 27 cystic fibrosis patients (mean age 12.8 years). SETTING: Two hospitals in Leeds, UK. RESULTS: Both forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) showed improvements over the course of treatment, although there was no difference in respiratory function between the two groups at any of three time periods during the study. The time to reach peak FVC was significantly reduced in the amiloride group (4.2 v 7.6 days; 95% CI 0.4 to 6.4 days), but not in the time to reach peak FEV1 (5.7 v 7.9 days; 95% CI -1.2 to 5.6 days). CONCLUSIONS: Amiloride did not result in a greater overall improvement in respiratory function. There was a suggestion that it may have an effect on the rate of improvement, and thus may possibly influence the duration of treatment. This hypothesis deserves further evaluation.     

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.     

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.