Efficacy and safety of a new apple-flavoured oral rehydration solution in children with acute gastroenteritis: a double-blind randomized controlled trial

Aim: To assess the efficacy and safety of a new oral rehydration solution (ORS) with improved flavour in the management of children with acute gastroenteritis (AGE). Methods: Children 4 to 48 months of age with AGE (≥3 loose or watery stools per day for >1 but <5 days) with mild‐to‐moderate dehydration (3% to 9% loss of body weight) according to the World Health Organization criteria randomly received regular hypotonic ORS (Na 60 mmol/L, glucose 78 mmol/L) or the same hypotonic ORS with an apple taste. Results: Of the 147 children randomized, 130 (88.4%) were available for intention‐to‐treat analysis. The proportion of children with the resolution of signs of dehydration in the experimental group compared with the control group was similar at 24 h (49/63 vs. 57/67, respectively, p = 0.28). There were also no significant differences in adequate weight gain (p = 0.48) and urine production at 24 h (p = 0.95) between groups. There were no differences between groups in any of the secondary outcome measures, including ORS intake. No adverse events were observed in the study groups. Conclusions: In an outpatient setting, there was no difference in efficacy between the study products. Both ORSs were equally effective and may be used interchangeably.     

猪肺表面活性物质治疗胎粪吸入综合征的多中心随机对照研究

目的在中国19家新生儿重症监护病房开展猪肺表面活性物质治疗足月儿或近足月儿重症胎粪吸入综合征(MAS)多中心随机对照临床试验,判断其疗效和安全性。方法61例重症MAS患儿在生后36h内入选试验,随机分为表面活性物质治疗组(PS,n=31)和对照组(C,n=30)。PS首剂给药量为200mg/(kg·w),重复给药时追加剂量为200、100、100mg/kg。主要疗效评估指标为PS治疗后24h氧合指数(OI)小于10,动脉/肺泡氧分压比值(a/APO2)较用药前基础值增加100%;次要评估指标为机械通气时间、并发症发生率和存活出院的患儿数。结果两组患儿一般临床特征相似。在随机化治疗后24h,与C组相比,PS组平均OI值降低(10.9vs.8.1)、有较多患儿a/APO2较基础值增加100%(48%vs.83%,P<0.01)、PaO2/FiO2曲线下面积更大[(3762±1877)vs.(2715±1644)mmHg·h(P<0.05,1mmHg=0.133kPa)]。在治疗的3、7天,上述参数PS组仍优于C组。两组间在机械通气时间、主要并发症发生率和存活率上差异无统计学意义。结论表面活性物质治疗重症MAS能改善氧合,不增加并发症的发生。     

儿童原发性夜间遗尿症治疗的临床随机对照研究

目的对3种遗尿症治疗方法进行临床随机对照研究,比较各种治疗方法的特点以及对原发性夜间遗尿症儿童的疗效。方法以138例确诊为原发性单一症状性夜间遗尿症的患儿为研究对象,在家长和患儿同意进行4个月的治疗并坚持随访情况下,将其随机分为3组：（1）生理．心理治疗组52例,使用报警器的条件反射训练与其他心理行为治疗整合的一体化方法;（2）药物治疗组46例,口服去氨加压素片剂;（3）综合治疗组40例,同时应用前两种方法治疗。家长和患儿决定暂不治疗或延期治疗的45例患儿归为对照组,并定期随访。对4组患儿4个月治疗结束时,和停止治疗3个月后遗尿的缓解情况进行比较分析。结果生理-心理治疗组的近期和远期治愈率分别为75．0％、71．2％;药物治疗组的近期和远期治愈率分别为47．8％、28．3％;综合治疗组的近期和远期治愈率分别为85．0％、80．0％。生理-心理治疗组与综合治疗组的近期、远期疗效均显著优于药物治疗组（P〈0．01）,生理-心理治疗组与综合治疗组的近期远期疗效差异无统计学意义（P〉0．05）。生理．心理治疗组起效慢、疗效巩固;药物治疗组起效快,停药后复发率高。结论 生理-心理治疗和药物去氨加压素治疗对我国儿童具有良好疗效。生理-心理治疗立足于发展儿童的夜间排尿控制能力,较药物治疗疗效更好,且复发率明显低于药物治疗,值得在国内遗尿症治疗中推广应用。     

肝素预防过敏性紫癜性肾炎肾损害的临床随机对照研究

目的　观察肝素预防过敏性紫癜性肾炎 (HSPN)的临床有效性和安全性。方法　采用前瞻性随机对照方法 ,将 2 2 8例过敏性紫癜 (HSP)患儿分为肝素治疗组 (119例 )和对照组 (10 9例 ) ,肝素治疗组患儿在起病和每次复发时给予肝素钠 12 0～ 15 0U/kg加入 10 %葡萄糖水 10 0ml中静脉滴注 ,每天 1次 ,连续 5d ;或肝素钙 10IU/kg皮下注射 ,每天 2次 ,连续 7d。对照组患儿在起病和每次复发时给予 10 %葡萄糖 10 0ml静脉滴注 ,每日 1次 ,连续 5d。两组患儿均同时给予基础治疗 (口服维生素C和芦丁治疗 ) ,直至临床症状消失。以后每 2周观察尿常规至患儿首次治疗后≥ 3个月。结果　平均随访 6个月 ,肝素治疗组发生肾炎 9例 (7 6 %) ,对照组发生肾炎 30例 (2 7 5 %) ,肝素治疗组肾炎的发生率明显低于对照组 (P <0 0 1)。肝素治疗组患儿肾炎出现的时间为 (82± 6 4)d ,对照组为(34± 32 )d(P <0 0 1) ;肝素治疗组在起病 3个月内出现肾炎者 4例 (4 4%) ,对照组 3个月内出现肾炎者 2 8例 (93%) ,其中 15例患儿是在 1个月内出现肾损害的。肝素治疗组中HSPN表现为单纯血尿 2例 ,血尿 +蛋白尿 6例 ,血尿 +肾病 1例 ;对照组单纯血尿 12例 (4 0 %) ,血尿 +蛋白尿 15例 (5 0 %) ,血尿 +肾病 3例 (10 %) ,两组间差异无显著意     

阻断乙型肝炎病毒宫内传播的随机对照研究

目的 最近10多年的研究表明，用乙肝疫苗主被动联合免疫能阻断母婴间乙肝病毒（HBV）传播，保护效果达到70％－90％，而宫内已感染HBV是生后免疫接种失败的主要原因，我们研究用乙肝免疫球蛋白（HBIG）多次产前注射，观察阻断HBV宫内传播的效果。方法 980例携带HBsAg孕妇随机分成两组，一组孕妇产前3个月（妊娠28周起）每4周肌注HBIG 200IU－400IU，直至临产，称HBIG组；另一组不注射为对照，称对照组。所有对象和其所生孩子出生时即采外周血，检测HBsAg、HBeAg，部分测HBV DNA，所有新生儿随访1年。结果 496例新生儿为对照组母亲所生，生后仅接种乙肝疫苗和HBIG；491例新生儿为HBIG组母亲所生，生后同样给予主被动联合免疫。结果显示对照组婴儿的宫内感染率为难4．3％；而HBIG组婴儿的宫内感染率为5．7％（x^2＝20．11，P＜0．001），宫内感染HBV的高危因素是母亲呈HBsAg、HBeAg双阳性或HBV DNA阳性。结论 研究提出产前多次肌注HBIG可有效减少HBV的宫内传播，未发现任何副作用。     

健康教育对轻中度铅中毒儿童干预作用的随机临床对照研究

目的评价健康教育对轻、中度儿童铅中毒的干预效果.方法血铅水平在100 μg/L以上的儿童200名,随机分为2组实验组107名,对照组93名.研究开始阶段,两组均要求儿童父母填写一份KABP问卷和家庭社会环境与健康问卷,随后对实验组采取健康教育进行干预,而对照组不采取任何措施.干预的时间为3个月,随后对2组的全部儿童进行血铅水平复测.结果实验组干预后父母的铅中毒知识均有所提高,前后比较差异均有高度统计学意义;而对照组对儿童铅中毒的概念和预防知识也有部分提高.实验组在健康教育后,儿童及父母多种接触铅高危行为也有显著改善;而对照组只有少数改善.两组儿童血铅水平均有所下降,血铅下降值分别为55 μg/L和33 μg/L,具有统计学意义(t=4.979, 3.398, P<0.01);但实验组比对照组多下降22 μg/L(t=3.531, P<0.01).采用多元逐步回归分析排除可能的混杂因素后,有14个变量最终进入血铅水平变化的逐步回归方程,这些变量有父母预防儿童铅中毒知识的提高、对儿童铅中毒态度的转变及儿童吃零食习惯的改变等.结论对父母进行健康教育可明显提高家长对儿童铅中毒预防知识的了解,有效降低轻中度铅中毒儿童的血铅水平.健康教育可作为轻中度儿童铅中毒临床处理的常规手段之一.     

Facilitation of neonatal nasotracheal intubation with premedication: a randomized controlled trial

OBJECTIVES: To determine if premedication reduces the time and number of attempts by junior medical staff to achieve nasotracheal intubation in neonates. The experimental design was a non-blinded randomized controlled pilot trial. The setting was a perinatal centre in a university teaching hospital. METHODS: Twenty infants (within the ranges of 25-40 weeks gestation, 650-3660 g and 1 h to 81 days of age) requiring semi-urgent intubation were randomized to either premedication with morphine, atropine and suxamethonium, or to awake intubation. RESULTS: There were no significant differences between the two groups in regard to prior intubation experience of the staff or infant weight or gestation. The intubation procedure, including intervening events, to completion was significantly faster in premedicated infants (median 60 s vs 595 s; P = 0.002) who were intubated at a younger postnatal age. It took twice as many attempts to intubate a conscious infant (median 2 vs 1; P = 0.010). There was a greater decrease in heart rate from the baseline in the unpremedicated group (mean 68 b.p.m. vs 29 b.p.m.; P = 0.017), but decreases in oxygen saturation were not different. Blood was observed in the oral and nasal passages after intubation in five of the awake infants and in one of the premedicated infants. CONCLUSIONS: The use of premedication reduces the total time and number of attempts taken to achieve successful nasotracheal intubation of neonates by junior medical staff under supervision.     

模拟随机对照试验——一种新的用于疗效比较研究的统计分析方法

目的 本研究旨在通过探索处理混杂因素的手段,创造一种新的用于观察性数据疗效比较研究的统计分析方法。方法 本方法基于以下原理：针对诊断为同种疾病接受不同治疗的一组患者,采用反复多次模拟随机化分组并根据RCT的统计分析策略进行疗效比较,以拒绝H0的试验频率和不拒绝H0的试验频率之比（odds值）及其95%CI作为判断不同治疗方法间疗效差异的依据。采用计算机模拟的方法获得统计量odds值的分布。对包含结局变量和混杂因素变量的模拟数据库进行随机化分组,对根据符合方案集分析(PP)策略保留下来的样本进行结局变量比较。重复100次随机化分组,并对每次随机化分组后结局变量进行比较,同时也对混杂因素变量的组间均衡性进行分析。计算100次结局变量比较分析结果中拒绝H0与不拒绝H0的比值,即odds值,重复100次odds值的计算过程得到odds值的点估计值及其95%CI。根据样本量（n1=n2=50,100,500和1 000）、组间差异的把握度和效应量产生多个模拟数据库,观察分析得到的odds值及其95%CI的一致性和稳定性。同时验证混杂因素在根据PP策略保留下来的样本的组间均衡性。结果 ①对不同样本量下疗效有差异数据库分析得到的odds值均>1,odds值及其95%CI均随把握度的增加呈上升趋势;②对不同样本量下疗效无差异数据库分析得到的odds值均<1,odds值及其95%CI均随把握度的增加呈下降趋势,二者变化均呈现良好的线性关系;③同时验证样本量相等和不相等的情况下,混杂因素组间均衡的概率均>95%。结论 将本文发明的方法命名为模拟随机对照试验方法,简称sRCT。运用sRCT对模拟数据库分析得到结果的一致性和稳定性高,实现了在均衡混杂因素的基础上,创建了一种用于观察性数据疗效比较研究的新方法。     

环孢素A治疗儿童难治性肾病综合征随机对照试验的系统评价

目的 评价环孢素A(CsA)治疗儿童难治性肾病综合征(RNS)的疗效和安全性.方法 按系统评价的要求全面检索了 Cochrane图书馆、PubMed、EMBASE、中国生物医学文献光盘数据库(CBMdisk)、中国期刊全文数据库(CNKI)和中国维普数据库(VIP),对符合纳入标准的文献按临床类型及干预措施分亚组进行Meta分析.结果 共纳入9篇文献(n=293),6篇4～7分,3篇1-3分.(1)在激素(GC)效应组中,CsA联合GC的近期疗效优于单用GC[OR值0.14,95%CI(0.03,0.71)],但与环磷酰胺、麦考酚酸酯的差异无统计学意义,比苯丁酸氮芥疗效差且易复发[OR值和95%CI分别为6.93(1.53,31.38)、0.06(0.01,0.58)],维持治疗期间保持CsA血药浓度在60～80 μg/L能降低远期复发率[OR值6.43,95%CI(1.21,34.19)],两组终末期肾病(ESRD)的发生率和病死率均为0.(2)在激素耐药组中,CsA的近期疗效优于安慰剂或支持治疗及环磷酰胺[OR值和95%CI分别为0.15(0.02,0.96)、0.41(0.03,5.00)],但复发率、ESRD的发生率和病死率的差异均无统计学意义.(3)CsA的安全性:CsA组的肾毒性、多毛和牙龈增生的发生率均高于对照组[OR值和95%CI分别为0.19(0.05,0.79)、0.06(0.02,0.19)、0.05(0.02,0.18)],但两组间高血压和肝毒性发生率的差异无统计学意义.结论 已有证据提示CsA能提高儿童RNS的近期疗效,但不能提高其远期和终点疗效,是治疗儿童RNS较理想的二线药物,其安全性较好,从总体趋势上看,CsA对儿童激素效应Ns的疗效优于激素耐药NS.此外,在维持治疗期间,保持CsA的血药浓度在60～80 ug/L能减少远期的复发率.     

硫酸镁和/或沙丁胺醇雾化吸入对哮喘患儿吸入乙酰胆碱激发后肺功能影响的随机对照研究

目的观察硫酸镁雾化能否改善哮喘患儿吸入乙酰胆碱激发后的肺功能,并与雾化吸入沙丁胺醇和硫酸镁＋沙丁胺醇进行比较。方法330例乙酰胆碱激发试验阳性的哮喘患儿随机分为3组,3组分别给予雾化吸入硫酸镁,沙丁胺醇,硫酸镁+沙丁胺醇,观察用药后2个时点（10 和20 min）第1秒用力呼气量（FEV1）、最大呼气流速(PEF）的肺功能指标。结果①3组患儿用药后2个时点的FEV1、PEF值均较激发值显著上升（P<0.05）,但3组2个时点的FEV1、PEF值两两比较差异无统计学意义（P>0.05）;②沙丁胺醇组及硫酸镁+沙丁胺醇组2个时点的FEV1、PEF值占预计值的百分比高于硫酸镁组（P<0.05）;③硫酸镁组和硫酸镁+沙丁胺醇组用药后20 min时点的FEV1及PEF值占预计值的百分比高于用药后10 min时点的百分比（P<0.05）。 结论硫酸镁雾化吸入能改善哮喘患儿吸入乙酰胆碱激发后的肺功能,但其效果不如单用沙丁胺醇;硫酸镁+沙丁胺醇联合应用不具有协同效应。     

中国儿科领域随机对照试验报告质量横断面调查

摘要目的评估CONSORT声明自1997年引入中国以来,中国儿科杂志发表RCT的报告质量是否得到提高。方法手工检索中国大陆被中国科学引文数据库（CSCD）收录的6种国内儿科杂志（《中华儿科杂志》、《中华小儿外科杂志》、《中国当代儿科杂志》、《中国实用儿科杂志》、《中国循证儿科杂志》和《临床儿科杂志》）,检索时间均为创刊至2010年12月。对照CONSORT声明的评价条目清单,设计标准的资料提取表格,评估纳入文献的报告质量,使用SPSS 18.0软件进行统计分析。结果619篇RCT文献进入分析。1997至2010年与1997年前发表的RCT相比,其在文题、摘要、引言、受试者招募、基线资料和辅助分析等方面的报告质量有一定的改善（P<0.05）,但在方法学的报告方面存在报告不充分或不准确的问题,如确定样本量的方法（0.6% vs 1.1%）、随机序列产生的方法（3.2% vs 7.6%）、分配隐藏（0 vs 1.1%）、盲法（0 vs 2.6%）等。进一步对稿约中要求CONSORT声明的《中国循证儿科杂志》发表的9篇RCT进行评估,其CONSORT条目符合率均高于其他儿科杂志,特别在方法学的报告方面,如确定样本量的方法、随机序列产生的方法、分配隐藏和盲法等。结论总体而言,CONSORT声明的引入并没有使中国儿科领域RCT的报告质量从根本上提高。在稿约中要求CONSORT声明的杂志可显著提高RCT的报告质量。     

Efficacy of a home-made spacer with acute exacerbation of bronchial asthma : A randomized controlled trial

Metered dose inhaler (MDI) with spacer is the preferred method for administration of aerosolized medications in pediatric asthma. The expense of commercial spacers limits their use and indigenous alternatives have therefore been developed. Information on the clinical efficacy of home-made spacers is limited. This study was conducted to compare the efficacy of a valve-less home-made spacer with a commercial spacer in delivering salbutamolvia MDI in acute asthma. Asthmatic children aged 5–15 years who presented with an acute exacerbation to the pediatric chest clinic of a tertiary care hospital were enrolled in a single blinded randomized parallel group study. The study patients received 10 puffs of salbutamol (100(igJ puff)via MDI-home-made spacer or MDI-commercial spacer. Pre and post inhalation measurements of peak expiratory flow rate (PEFR), oxygen saturation (SaO2), respiratory rate (RR), pulse rate (PR) were made and compared. Sixty children were enrolled in the study, 31 were administered salbutamolvia the home-made spacer and 29via the commercial spacer. The median increase in PEFR was similar in both the groups (20.8% vs22.2%, p=0.4), clinical improvement being satisfactory in all patients. The valve-less home-made spacer is equally efficacious and cheaper than the commercial spacer in administering bronchodilators in acute exacerbations of asthma. Further studies on the efficacy of home-made spacer in delivery of inhaled steroids are needed.     

A randomized controlled clinical trial of zinc, vitamin A or both in undernourished children with persistent diarrhea in Bangladesh

In a double-blind randomized controlled clinical trial, moderately malnourished Bangladeshi children (61-75% of the median weight/age) were studied for the effect of zinc and/or vitamin A supplementation on the clinical outcome of persistent diarrhea. Children 6 mo to 2 y of age with diarrhea for more than 14 d were randomly allocated into 4 groups of 24 receiving a multivitamin syrup and (i) zinc (20 mg elemental), (ii) vitamin A, (iii) both zinc and vitamin A, or (iv) neither, in 2 doses daily for 7 d. Clinical data on recovery and on stool output, consistency and frequency were recorded for 7 d, and weight change from day 1 to day 7 was assessed. The baseline characteristics of the four study groups were comparable. The mean daily stool outputs from days 2 to 7 of therapy were significantly less in the zinc and zinc plus vitamin A groups, but not in the vitamin A group, in comparison with the control group. In children receiving zinc, the cumulative stool weight in the 7 d was 39% less than in the control group (p < 0.001) and 32% less than in the vitamin A group (p = 0.006). The cumulative stool weight in the zinc plus vitamin A group was 24% less than in the control group (p < 0.001), but the 14% lower output than in the vitamin A group was not statistically different. The change in body weight over the 7 d study period was significantly different between the group receiving zinc and the control group (+111 g vs -90 g, p = 0.045). The rate of clinical recovery of children within 7 d was significantly greater in the zinc group (88%) compared with the control group (46%, p = 0.002) or vitamin A group (50%, p = 0.005), but not statistically different from the zinc plus vitamin A group (67%, p = 0.086). Conclusion: The results indicate that zinc, but not vitamin A, supplementation in persistent diarrhea reduces stool output, prevents weight loss and promotes earlier recovery.     

一氧化氮吸入治疗新生儿胎粪吸入综合征的随机对照研究

目的 观察吸入低浓度一氧化氮(NO)治疗胎粪吸入综合征(MAS)的疗效和安全性.方法 46名氧合指数(OI)≥15的重症MAS患儿入选试验,采用随机数字法随机分为NO组(NO,n=21)和对照组(C,n=25),所有患儿均在本院NICU接受机械通气同步间歇指令模式(SIMV)治疗.NO组吸入NO初始剂量15 ppm,吸入1 h如血氧饱和度(SpO2)提高＞10%,动脉血PaO2提高＞10 mm Hg(1 mm Hg=0.133 kPa)判定为有效(否则判定为无效,增加吸入NO的浓度,最多不超过20 ppm).两组均监测0、1、24 h的动脉血气和体循环血压、肺动脉压,记录吸氧浓度、氧合指数、呼吸机参数、呼吸机应用时间、氧暴露时间,吸入NO 12～24 h测定血高铁血红蛋白浓度.结果 NO组和对照组在1 h和24 h,OI差异有统计学意义(F=181.77,P＜0.01);NO组患儿在吸入NO后1 h氧合指数即与0 h时对照差异有统计学意义(F=35.27,P＜0.01),而对照组直至24 h与0 h比较,差异才有统计学意义(F=20.16,P＜0.01);随着NO的持续吸入,NO组肺动脉压力逐渐下降,而体循环收缩压无明显改变(P＞0.05),两组间肺动脉压力在1 h(t=2.41,P＜0.05)、24 h(t=3.11,P＜0.01)差异均有统计学意义;血高铁血红蛋白浓度未发现异常增高;两组间住院天数(t=2.86,P＜0.05)、氧暴露时间(t=2.53,P＜0.05)、机械通气时间(t=2.41,P＜0.05)差异均有统计学意义,而死亡率(χ2=0.21,P＞0.05),和颅内出血的发生率(χ2=0.00,P＞0.05)差异无统计学意义.结论 吸入NO治疗重症MAS能较迅速改善氧合,缩短呼吸机应用时间、氧暴露时间及住院天数,并未增加主要并发症的发生.     

Children diagnosed with type 1 diabetes: a randomized controlled trial comparing hospital versus home-based care

Aim: To compare two different regimens for children diagnosed with type 1 diabetes: hospital‐based care or hospital‐based home care (HBHC), referring to specialist care in a home‐based setting. Method: The trial took place in Sweden with a randomized controlled design and included 60 children, aged 3–15 years. After 2–3 days with hospital‐based care, children were randomized to either continued hospital‐based care or to HBHC for 6 days. The primary outcome was the child’s metabolic control after 2 years. Secondary outcomes were set to evaluate the family and child situation as well as the healthcare services. This article presents data 6 months after diagnosis. Results: Results showed equivalence between groups in terms of metabolic control, insulin dose, parents’ employment and working hours as well as parents’ and significant others’ absence from work related to the child’s diabetes. Parents in the HBHC were more satisfied with the received health care and showed less subsequent healthcare resource use. The level of risk for the family’s psychosocial distress assessed at diagnosis was associated with the subsequent use of resources, but not with metabolic control. Conclusion: HBHC was found to be an equally safe and effective way of providing care as hospital‐based care at the onset of type 1 diabetes for children who are medically stable.     

Web-based consultations for parents of children with atopic dermatitis: results of a randomized controlled trial

Aim: To analyse how web-based consultations for parents of children with atopic dermatitis affect self-management behaviour, health outcome, health resource use and family costs.
Methods: Ninety-eight children with atopic dermatitis were randomly assigned to intervention and control groups. The intervention group received remote dermatology consultations through a secure web-based communication system. The control group was encouraged to seek treatment through traditional means such as general practitioner visits and hospital care. Both groups received an extensive individual educational session prior to the intervention.
Results: Thirty-eight percent of the intervention group used web-based consultations 158 times ranging from 1 to 38 consultations per patient. We found no change in self-management behaviour, health outcome or costs. The intervention group tended to have fewer visits to practitioners offering complementary therapies than the control group, and we found a positive correlation between emergency visits at baseline and messages sent. Both groups, however, reduced the mean number of skin care treatments performed per week and had fewer total health care visits after the intervention.
Conclusion: We found no effect of supplementing traditional treatment for childhood dermatitis with web-based consultations. This study showed that web consultations is feasible, but more research is needed to determine its effect on self-management skills, health outcome and resource use.     

Cost-effectiveness analysis of a system-based approach for managing neonatal jaundice and preventing kernicterus in Ontario

OBJECTIVE:

To evaluate the incremental cost-effectiveness of a system-based approach for the management of neonatal jaundice and the prevention of kernicterus in term and late-preterm (≥35 weeks) infants, compared with the traditional practice based on visual inspection and selected bilirubin testing.

STUDY DESIGN:

Two hypothetical cohorts of 150,000 term and late-preterm neonates were used to compare the costs and outcomes associated with the use of a system-based or traditional practice approach. Data for the evaluation were obtained from the case costing centre at a large teaching hospital in Ontario, supplemented by data from the literature.

RESULTS:

The per child cost for the system-based approach cohort was $176, compared with $173 in the traditional practice cohort. The higher cost associated with the system-based cohort reflects increased costs for predischarge screening and treatment and increased postdischarge follow-up visits. These costs are partially offset by reduced costs from fewer emergency room visits, hospital readmissions and kernicterus cases. Compared with the traditional approach, the cost to prevent one kernicterus case using the system-based approach was $570,496, the cost per life year gained was $26,279, and the cost per quality-adjusted life year gained was $65,698.

CONCLUSION:

The cost to prevent one kernicterus case using the system-based approach is much lower than previously reported in the literature.