美芬那敏铵糖浆消除或缓解儿童急性上呼吸道感染症状有效性和安全性的临床研究

目的以愈美甲麻敏糖浆为对照,评价美芬那敏铵糖浆消除或缓解儿童急性上呼吸道感染症状的有效性和安全性。方法应用随机、盲法、平行对照方法,在11个临床研究中心共纳入FAS分析患儿253例,试验组127例,最终纳入符合方案集(PPS)分析118例;对照组126例,纳入PPS分析116例。试验组服用美芬那敏铵糖浆,对照组服用愈美甲麻敏糖浆,遵医嘱连续服用不超过7 d,至少服用3 d。结果入组时两组的年龄、性别、急性上呼吸道感染评分等的差异均无统计学意义(P0.05)。试验组急性上呼吸道感染症状缓解中位时间为51.0 h(95%CI:43.0~62.0 h),对照组为56.0 h(95%CI:48.0~64.0 h),差异无统计学意义(P0.05);校正中心和基线影响后,试验组非劣效于对照组;试验组与对照组急性上呼吸道感染症状积分差异无统计学意义(F=0.14,P=0.710);急性上呼吸道感染单项症状消失率,两组间差异均无统计学意义(P0.05);两组间依从性评价的差异无统计学意义(P0.05);试验组和对照组均各有7例不良事件,且均有1例判断为药物不良反应,不良反应发生率均为0.8%。结论美芬那敏铵糖浆在治疗儿童急性上呼吸道感染时能有效快速缓解症状,其疗效和安全性非劣效于传统药物愈美甲麻敏糖浆。     

黄龙止咳颗粒联合孟鲁司特钠咀嚼片治疗儿童咳嗽变异性哮喘多中心随机对照临床研究北大核心CSCD

目的评价黄龙止咳颗粒联合孟鲁司特钠咀嚼片治疗儿童咳嗽变异性哮喘(CVA)肺肾气虚、痰热郁肺证的临床疗效及安全性。方法采用分层区组随机、双盲、平行对照的临床研究方法,于2018年3月至2019年9月纳入8个研究中心(天津中医药大学第一附属医院、山东省千佛山医院、北京中医药大学东方医院、中国医科大学附属盛京医院、河南中医药大学第一附属医院、天津市儿童医院、上海市中医医院、深圳市儿童医院)160例病例,其中试验组和对照组各80例。试验组予黄龙止咳颗粒和孟鲁司特钠咀嚼片;对照组予孟鲁司特钠咀嚼片及黄龙止咳颗粒模拟剂,用法用量同试验组。两组均连续治疗4周。观察两组疾病控制情况及中医疗效,比较两组咳嗽症状严重程度评分、中医证候评分和、肺功能及安全性指标。结果160例进入全分析集(FAS)、安全性数据集(SS)、152例进入符合方案数据集(PPS)。试验组治疗4周控制73例、部分控制3例、未控制1例,对照组控制63例、部分控制11例、未控制1例,试验组与对照组病情控制情况比较,差异有统计学意义(P<0.05),PPS、FAS分析结论一致。治疗4周,试验组中医证候疗效优于对照组,日间咳嗽症状严重评分、夜间咳嗽症状程度评分、中医证候积分和均低于对照组,两组比较差异有统计学意义(P<0.05),PPS、FAS分析结论一致。该研究发生不良事件2例,其中1例判断为不良反应。两组不良事件及不良反应发生率比较差异无统计学意义(P>0.05)。结论黄龙止咳颗粒联合孟鲁司特钠咀嚼片治疗儿童CVA肺肾气虚、痰热郁肺证疾病控制情况、中医证候疗效优于单独使用孟鲁司特钠咀嚼片,并可减轻患儿咳嗽症状严重程度,改善相关症状,安全性较好。     

13C-尿素呼吸试验对儿童幽门螺杆菌感染根除后1年的随访

目的　探讨洛赛克、克拉霉素、阿莫西林三联根除儿童幽门螺杆菌 (Hp)感染的远近期疗效。 方法　经1 3C尿素呼吸试验 (1 3C UBT)及血清Hp IgG测定 2项阳性的反复腹痛儿 95例 ,随机分为治疗组 (60例 )与安慰剂组 (35例 ) ,治疗组接受洛赛克 0 .8mg/ (kg·d) ,每天一次 ,克拉霉素 1 5mg/ (kg·d) ,每天 2次 ,阿莫西林 30mg/ (kg·d) ,每天 3次 ,三联口服治疗 ;疗程 1周。停药后 1 ,3 ,6 ,1 2个月门诊随访 ,复查1 3C UBT及Hp IgG。 结果　 1 .治疗组停药后 4周腹痛的总有效率 96 .7% ,而安慰剂组仅 34 .6 % ;治疗组Hp根除率为 90 % ,明显高于安慰剂组 1 4 .3 %。 2 .治疗组Hp根除后 3 ,6 ,1 2个月复查Hp再感染率分别为 1 .85 %、1 .85 %、3 .57%。 结论　 1 .洛赛克等三联根除反复腹痛儿Hp感染临床效果显著 ,Hp根除率高 ,远近期疗效均好 ,1年再感染率低。2 .1 3C UBT监测Hp根除情况快捷准确。     

双歧杆菌BB-12治疗婴幼儿腹泻临床疗效对照研究

目的评估双歧杆菌BB-12对婴幼儿腹泻治疗的有效性和安全性。方法对2015年12月至2016年8月吉林大学白求恩第一医院小儿消化内科诊治的120例腹泻患儿,采用随机、单盲方法,分为双歧杆菌BB-12治疗组、枯草杆菌二联活菌阳性对照组、未添加益生菌的安慰剂组,各40例。均配合蒙脱石散及补液等对症治疗,比较各组病例临床资料并进行分析。结果治疗组的显效率及有效率分别为37.50%、52.50%,阳性对照组为42.50%、42.50%,安慰剂组为17.50%、52.50%,差异有统计学意义(P0.05),治疗组与阳性对照组相比,差异无统计学意义(P0.05)。3组大便次数:第4天治疗组(3.10±1.41)次/d、阳性对照组(3.05±1.63)次/d、安慰剂组(3.93±1.91)次/d;第7天治疗组(1.45±0.64)次/d、阳性对照组(1.43±0.90)次/d、安慰剂组(1.95±1.30)次/d,3组较治疗前均明显减少,差异有统计学意义(P0.05)。但治疗组与阳性对照组相比,差异无统计学意义(P0.05),与安慰剂组比较差异有统计学意义(P0.05)。3组患儿治疗后腹泻好转所需天数方面,治疗组、阳性对照组及安慰剂组分别为(4.20±1.32)d、(4.40±1.37)d、(5.18±1.57)d,3组差异有统计学意义(P0.05),但治疗组与阳性对照组相比,差异无统计学意义(P0.05)。结论双歧杆菌BB-12治疗婴幼儿腹泻安全有效。     

大剂量甲基强的松龙治疗特发性血小板减少性紫癜的疗效观察

为探讨不同方法给予大剂量甲基强的松龙 (MP)治疗特发性血小板减少性紫癜 (ITP)的疗效。通过A、B两组大剂量MP与C组常规剂量强的松治疗ITP的疗效对照进行研究。其中A组予MP 2 0～ 3 0mg kg·d ,连用三天后改为强的松口服 ;B组予MP2 0～ 3 0mg kg·d ,连用三天后减半量再用三天 ,后改为强的松口服 ;C组予强的松 1～ 2mg kg·d口服。结果 ,有效率比较 ,治疗B组 ( 95 8% )与A组 ( 89 4% )比较无显著性差异 ,两治疗组与对照C组 ( 72 % )比较有显著性差异。治疗后血小板计数变化比较 ,治疗后 7天和 14天 ,B组血小板数明显高于A、C二组 ,B、A二组及B、C二组均有显著性差异。结果示 :治疗B组治疗ITP能迅速减轻出血症状 ,升高血小板数 ,有效率高 ,偶见副作用 ,是治疗ITP的一种安全有效的方法 ,值得临床推广。     

HBsAg阳性孕妇的婴儿阻断有效后继续随访和治疗的研究

目的探讨HBsAg阳性孕妇的婴儿阻断有效后继续随访和治疗的必要性和临床意义。方法2001-01—2004-01对南京第二医院HBsAg阳性孕妇及婴儿实施联合免疫,婴儿于12月龄抽血检测乙肝病毒标志物(HBVm)、HBV-DNA和肝功能。将获阻断有效的4种HBVm模式(抗HBs<100mIU/mL,抗HBs、抗HBc两项阳性,抗HBs、抗HBe、抗HBc三项阳性,HBsAg或HBeAg低滴度)的婴儿分为A、B1、C1、D1四组,后三组设B2、C2、D2对照组,对A、B1、C1组婴儿再予乙肝疫苗(HBVac)20μg接种3次,D1组予同剂量HBVac治疗12次,对照组不作任何治疗。24月龄时随访HBVm、HBV-DNA和肝功能。结果治疗有效率A组为100%(24/24),B1组57.1%(20/35),C1组66.7%(10/15),D1组70.0%(7/10)。B1、C1、D1组婴儿治疗后抗HBs平均滴度分别为(745.34±238.81)、(691.65±153.76)、(602.56±212.83)mIU/mL,明显高于对照组,P<0.05。B1、C1、D1组婴儿治疗前后HBV-DNA阳性率和丙氨酸氨基转移酶(ALT)差异无显著性,P>0.05。结论获阻断有效的婴儿有必要继续随访,多次予HBVac免疫治疗可以提高抗HBs滴度,清除乙肝病毒的低水平感染。     

不同剂量克拉霉素三联疗法根除儿童消化性溃疡幽门螺杆菌的疗效观察

目的　研究克拉霉素不同剂量的三联疗法对消化性溃疡患儿的幽门螺杆菌 (HP)根除和疼痛缓解的疗效及不良反应。方法　采用含大剂量 (A组 )和小剂量 (B组 )克拉霉素的PPI三联疗法并与含羟氨苄青霉素 (C组 )的PPI三联疗法组进行对比的前瞻性研究。结果　HP根除率A组为 96 % (2 4/ 2 5 ) ,B组为 91 3 % (2 1/ 2 3) ,C组为 90 % (18/ 2 0 ) ,3组间无显著性差异 (P >0 0 5 )。A、B和C各组治疗后 3天及 1周时腹痛缓解程度与治疗前相比均有显著性差异 (P <0 0 5 ) ;但 3组之间在治疗后腹痛缓解程度均无显著性差异 (P >0 0 5 )。主要不良反应是恶心、呕吐、纳差和轻度腹泻 ,个别可有异味感。不良反应总的发生率为 19 1% ,其中A组为 2 8% ,B组为4% ,C组为 2 5 % ,B组与A组、C组间均有显著性差异 ,P <0 0 5。结论　根除HP的PPI三联疗法中 ,均以含克拉霉素的根除率高 ,且含小剂量克拉霉素的PPI三联疗法是在儿童中较佳的根除方案。     

三联短程疗法治疗幽门螺杆菌现症感染的疗效观察

目的探讨洛赛克、克拉仙、阿莫仙三联短程疗法根除儿童幽门螺杆菌(HP)现症感染的疗效。方法经13C尿素呼吸试验(13C-UBT)及血清HP-IgG测定2项阳性的反复腹痛患儿63例,分为治疗组36例与安慰剂组27例。治疗组接受洛赛克、克拉仙、阿莫仙三联治疗,安慰剂组口服安慰剂;疗程均为1周。停药后4周门诊复诊并复查13C-UBT。结果治疗组与安慰剂组临床总有效率分别为100％和22.2％,HP根除率分别为83.3％和11.1％。结论部分小儿反复腹痛与HP现症感染密切相关;洛赛克、克拉仙、阿莫仙三联1周短程疗法根除反复腹痛儿童HP现症感染临床效果好,HP根除率高,副作用少。     

伪麻美芬滴剂治疗上呼吸道感染患儿鼻部症状的疗效和安全性

目的评价小儿伪麻美芬滴剂治疗由上呼吸道感染(上感)引起的鼻部症状的疗效和安全性。方法将120例确诊为上感伴鼻部症状的患儿随机分为治疗组和对照组。治疗组60例。男36例,女24例;服用小儿伪麻美芬滴剂。对照组60例。男34例,女26例;服用臣功再欣。两组年龄均为3个月~3岁。观察两组疗效和不良反应。结果治疗组总有效率98.3%,对照组总有效率86.67%,两组疗效比较有显著性差异(P<0.05)。结论小儿伪麻美芬滴剂对由上感引起的鼻部症状有明显疗效,起效迅速,不良反应小。     

自拟通腑泻热汤防治小儿高热惊厥30例疗效观察

目的观察自拟通腑泻热汤防治小儿高热惊厥的疗效。方法将有高热惊厥史的急性上呼吸道感染患儿60例随机分为观察组和对照组各30例。对照组常规抗感染、对症处理;观察组在对照组基础上口服自拟通腑泻热汤治疗,每日1剂,3 d为1个疗程,观察治疗效果。结果观察组显效率86.66%(26/30)和总有效率93.33%(28/30),均高于对照组60.00%(18/30)、73.33%(22/30),差异有统计学意义(P<0.05)。结论自拟通腑泻热汤预防高热惊厥有良好效果。     

Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized,controlled clinical trials

BACKGROUND: Previous studies have shown a positive treatment effect of individualized homeopathic treatment for acute childhood diarrhea, but sample sizes were small and results were just at or near the level of statistical significance. Because all three studies followed the same basic study design, the combined data from these three studies were analyzed to obtain greater statistical power. METHODS: Three double blind clinical trials of diarrhea in 242 children ages 6 months to 5 years were analyzed as 1 group. Children were randomized to receive either an individualized homeopathic medicine or placebo to be taken as a single dose after each unformed stool for 5 days. Parents recorded daily stools on diary cards, and health workers made home visits daily to monitor children. The duration of diarrhea was defined as the time until there were less than 3 unformed stools per day for 2 consecutive days. A metaanalysis of the effect-size difference of the three studies was also conducted. RESULTS: Combined analysis shows a duration of diarrhea of 3.3 days in the homeopathy group compared with 4.1 in the placebo group (P = 0.008). The metaanalysis shows a consistent effect-size difference of approximately 0.66 day (P = 0.008). CONCLUSIONS: The results from these studies confirm that individualized homeopathic treatment decreases the duration of acute childhood diarrhea and suggest that larger sample sizes be used in future homeopathic research to ensure adequate statistical power. Homeopathy should be considered for use as an adjunct to oral rehydration for this illness.     

微创扩清联合支气管灌洗术治疗小儿急性脓胸的效果观察

目的探讨微创扩清联合支气管灌洗术治疗小儿急性脓胸的效果。方法选取本院2011年4月至2015年4月收治的68例小儿急性脓胸患儿,随机分为试验组和对照组,两组各34例,对照组采用微创扩清治疗,试验组采用微创扩清联合支气管灌洗术治疗。比较两组治疗效果。结果试验组总有效率(97.1%)明显高于对照组(79.4%),差异有统计学意义(x~2=6.248,P0.05);两组治疗后PO2、PCO2及WBC指标明显优于治疗前;试验组治疗后PO2为(80.30±9.26)mmHg,PCO2为(45.53±4.27)mmHg,WBC为(8.85±3.62)G·L~(-1);对照组PO2为(70.33±8.75)mmHg,PCO2为(51.61±5.40)mmHg,WBC为(10.81±4.00)G·L~(-1),差异有统计学意义,P0.05。试验组住院时间(8.8±2.4)d,明显短于对照组的(15.9±2.6)d,差异有统计学意义(t=5.246,P0.05)。结论采用微创扩清联合支气管灌洗术治疗小儿急性脓胸可以有效改善患者症状,康复快。     

亚低温联合促红细胞生成素治疗足月儿缺氧缺血性脑病的安全性观察

目的 研究亚低温联合促红细胞生成素（EPO）治疗中、重度足月儿缺氧缺血性脑病（HIE）的安全性,为开展多中心研究亚低温联合EPO治疗足月儿HIE的疗效奠定基础。方法 对2012年2月至2015年3月收住复旦大学附属儿科医院NICU满足亚低温治疗标准并知情同意下的中、重度足月儿HIE随机分组。实验组给予亚低温治疗72 h联合EPO(1 000 U·kg-1,静脉滴注, 隔天1次,14 d);对照组给予亚低温治疗72 h和与EPO同等剂量、同样给药方法的生理盐水。监测患儿治疗期间的生命体征,治疗期间放弃治疗事件,记录亚低温治疗前、亚低温治疗结束时、EPO疗程结束后的血生化指标,观察严重心律失常、大静脉血栓、不可纠正的低血压、死亡等严重不良事件,低血压、凝血功能障碍、肾功能异常等一般不良事件。比较两组间不良事件发生率的差异。结果 44例足月儿HIE进入本文安全性观察,其中实验组25例,对照组19例。3例重度HIE足月儿（实验组2例,对照组1例）亚低温治疗期间主动放弃治疗。两组在EPO相关不良事件血生化指标Hb、RBC、 Hct和 PLT差异均无统计学意义;两组在HIE并发症及其治疗严重和一般不良事件的发生率差异均无统计学意义。结论 亚低温联合EPO治疗中、重度足月儿HIE未发生与治疗相关的严重不良事件,安全可行。     

Assessing the efficacy of the recombinant human granulocyte colony-stimulating factor "rhG-CSF" in the treatment of early neonatal sepsis in premature neonates

OBJECTIVE: To evaluate the efficacy of the recombinant human granulocyte colony-stimulating factor (rhG-CSF) in the treatment of early-onset neonatal sepsis among premature infants.MATERIALS AND METHODS: A double-blind, randomized, placebo-controlled trial was performed among forty-four preterm neonates who had "clinical diagnosis" of early-onset sepsis. The treatment group (n=22) received 10 micro g/kg/d of rhG-CSF, IV once daily for three consecutive days, and the placebo group (n=22) received the same volume of a visually-indistinguishable vehicle. Prior to the first dose, and prior to the second and third doses, and again 10 days after the first dose, we measured tumor necrosis factor-a, interleukin-6, granulocyte-macrophagocyte colony-stimulating factor, G-CSF, leukocyte count, absolute neutrophil count, immature/total neutrophil ratio, platelet count, and hemoglobin concentration. A bone marrow aspiration was performed seven days after the first dose, and both the neutrophil storage pool (NSP) percent and the NSP/NPP (neutrophil proliferative pool) ratios were tabulated.RESULTS: The treatment and placebo groups were of similar gestational age (29-/+ 3 vs 31-/+ 3 weeks) and birth weight (1376 -/+ 491 vs 1404 -/+ 508 grams). They had similar Apgar scores and 24 hour SNAP scores. No deaths occurred during the first week of life among the treatment group while three deaths occurred in the placebo group. RhG-CSF treatment did not alter the serum concentrations of the cytokines measured (except for G-CSF). Serum G-CSF levels, blood leukocyte counts, absolute neutrophil counts, NSP percentages, and NSP/NPP ratios were higher in the treatment group 24 hours and 72 hours after dosing. The occurrence of a subsequent infection over the two week period following dosing was significantly lower in the treatment group (n=2) than in the placebo group (n=9; p<0.02, RR 0.19 [0.05-0.78]). The overall mortality rate during the entire hospitalization was not different between treatment and placebo groups.CONCLUSIONS: Administration of rhG-CSF to premature neonates with the clinical diagnosis of early-onset sepsis was associated with lower incidence of nosocomial infection over the ensuing three weeks period, but it did not change the overall mortality rate.     

Salbutamol or mist in acute bronchiolitis

Abstract Background : The role of bronchodilators in the treatment of bronchiolitis remains controversial.
Methods : A double-blind, placebo controlled trial was performed to evaluate the clinical response to nebulized salbutamol. One hundred and fifty-six infants aged between 7 weeks and 24 months who had had an episode of wheezing and other signs and symptoms of bronchiolitis were randomized to three groups as follows: (i) nebulized salbutamol was administered to 52 patients in group I at a dose of 0.15 mg/kg in 2 mL saline; (ii) saline was nebulized to 52 patients in group II and (iii) in group III 52 patients received mist in a tent. All three groups were administered oxygen during the procedures. Treatment was repeated with the same agent after 30 min if the respiratory score was 5 or more. Respiratory rate, heart rate, oxygen saturation and presence of cyanosis, wheezing, retractions were recorded before and after each treatment.
Results : The decrease in the respiratory score was 5.2 ± 1.8, 0.82 ± 2.4 and 1.7 ± 1.3 in group I, II and III, respectively. The decrease in group I was significantly higher than in the other groups. Heart rate was similar between groups. Oxygen saturation decreased in group I without reaching statistical significance.
Conclusions: Salbutamol was shown to be effective and safe in the treatment of acute bronchiolitis.     

Low‐dose budesonide improves exercise‐induced bronchospasm in schoolchildren

The aim of this study was to compare the clinical efficacy of low‐dose inhaled budesonide (once or twice daily) and placebo, administered via Turbuhaler^®, on exercise‐induced bronchoconstriction (EIB) in children with mild asthma. Fifty‐seven steroid‐naive children (7–16 years old; 41 boys, 16 girls) with EIB participated in this sub‐population study according to the following inclusion criterion: a maximum fall in forced expiratory volume in 1 s ( FEV ₁) ≥ 10% after a standardized treadmill test. Mean baseline FEV ₁ was 100.3% of predicted, and mean maximum fall in FEV ₁ after the standardized exercise test was 22%. The study was a double‐blind, randomized, parallel‐group design. After 2 weeks of run‐in, the children received inhaled budesonide 100 µg or 200 µg once daily in the morning, 100 µg twice daily, or placebo, for 12 weeks. After 12 weeks of treatment, the fall in FEV ₁ after the exercise test was significantly less in all three budesonide groups (7.2–7.8%) vs. placebo (16.7%). Daytime symptom scores were significantly lower in all three budesonide groups compared with placebo (p < 0.02). The three budesonide groups did not differ significantly, and no significant change in lung function was found in any group. Therefore children with mild asthma, but with significant EIB, improved their exercise tolerance and symptom control after 3 months of treatment with a low dose of inhaled budesonide given once or twice daily.     

布地奈德干预治疗重度新生儿急性呼吸窘迫综合征的临床分析

目的探讨布地奈德对重度新生儿急性呼吸窘迫综合征(neonatal acute respiratory distress syndrome,NARDS)的治疗效应。方法选择2017年12月31日至2019年11月30日在解放军总医院第七医学中心八一儿童医院NICU住院的70例重度NARDS为研究对象,随机分为干预组和对照组,每组35例。干预组经气管插管导管内滴入布地奈德,每次0.5 mg/kg,每8小时一次,连用2 d;对照组以同样方式给予相同体积的生理盐水。收集两组患儿的围产期孕母资料、新生儿资料和血气分析指标等。采用两独立样本t检验、χ^2检验或Fisher精确概率法进行统计学分析。结果两组围产期孕母资料比较,差异无统计学意义(P>0.05)。干预组HFOV使用的比例(74.3%)高于对照组(51.4%)(χ^2=3.916,P<0.05)。干预组使用肺表面活性物质的比例(45.7%)低于对照组(71.4%)(χ^2=4.769,P<0.05));干预组气漏发生的比例(2.9%)低于对照组(20.0%)(P<0.05);干预组气道高反应性(咳嗽)发生的比例(14.3%)低于对照组(48.6%)(χ^2=9.545,P<0.05)。两组间的住院时间、死亡和体外膜肺氧合(ECMO)治疗的比例差异无统计学意义(P值均>0.05);两组间高血压、水肿、低钾血症、高钠血症发生的比例比较差异无统计学意义(P值均>0.05)。干预组与对照组比较,治疗前和治疗后7 d两组的二氧化碳分压(PaCO2)、氧分压(PaO2)和氧合指数(OI),3项指标差异均无统计学意义(P值均>0.05)。结论布地奈德能减少气漏、阻止或减轻气道高反应性的发生,对NARDS具有治疗效应。     

Establishing enteral feeding in preterm infants with feeding intolerance: a randomized controlled study of low-dose erythromycin

OBJECTIVE: A prospective, double-blind, randomized, controlled trial was conducted to evaluate the effect of low-dose erythromycin on the time taken to attain full enteral feedings in preterm infants with very low birth weight and feeding intolerance. METHODS: Two groups of preterm infants (birth weight 相似文献   

Multicenter randomized placebo controlled trial of therapy with intravenous immunoglobulin in decreasing mortality due to neonatal sepsis

OBJECTIVE: To determine whether therapy with intravenous immunoglobulin G (IVIG) would decrease mortality in neonatal sepsis. SETTING: Three tertiary care neonatal intensive care units in the city of Bangalore. METHODS: All neonates admitted to the Neonatal Intensive Care Units with the clinical diagnosis of sepsis and having at least C-reactive protein and one other rapid diagnostic criteria positive were enrolled. Neonates with a birth weight of less than 1000 g and those with any major congenital malformation were excluded. The neonates were randomized to receive 1 g/kg of IVIG on three consecutive days or an equivalent amount of placebo. The rest of the treatment including antibiotics and supportive care was as per the treating physician's decision. The main outcome variable was survival. RESULTS: The trial was carried out over a period of 8 months and recruited 58 neonates. Seven neonates who qualified but did not receive either IVIG or placebo were taken into a separate control group, and one baby who received only one dose of IVIG was excluded from the analysis. Twenty-five neonates were enrolled into the IVIG arm and 25 in the placebo arm. The neonates in the therapy and placebo groups were comparable in terms of birth weight (2144+/-675 g vs. 2072+/-682 g), gestation (37.0+/-3.56 vs. 35.8+/-3.52 weeks), sex distribution, duration of stay, and number requiring ventilation. The placebo group had a significantly higher number of babies with positive blood culture. Seven babies in each group died (p>0.05). There was no significant benefit in using IVIG (OR 1.0; 95% CI 0.25-4.07) (p = 0.74). CONCLUSION: In the sample studied therapy with IVIG did not reduce mortality in neonatal sepsis     

Comparative response in growth and bone status to three dexamethasone treatment regimens in infant piglets

The objectives of this study were 1) to determine whether a zenith in bone formation (indicated by circulating osteocalcin) existed at night in early life, and 2) to compare the effects of three different dexamethasone (DEX) treatment regimens on bone turnover, bone mineral content, and growth. Three DEX treatment regimens were tested in 8-d-old piglets (n = 8/group): 1) low evening dose of DEX (0.5 mg/kg/d) as 70% in the morning and 30% in the evening for 10 d; 2) tapering course of DEX (0.5, 0.3, and 0.2 mg/kg/d) as 50% in the morning and 50% in the evening for 14 d; and 3) constant dose of DEX (0.5 mg/kg/d) as 50% in the morning and 50% in the evening for 10 d. Oral water placebo groups were tested with the same time courses. At pretreatment, plasma osteocalcin was significantly higher (p < 0.05) at 0100 than at 0900 and 1700. At necropsy, measures for DEX groups were calculated as Z-scores using values from the placebo groups. The low evening DEX dose led to a significantly lower reduction in plasma osteocalcin compared with the tapered and constant dosing regimens (p < 0.05). The significant weight. reduction in the DEX group occurred at d 9 in the low evening dose regimen but at d 7 in the constant dosing regimen, compared with the placebo group. Bone mineral content Z-score was reduced similarly in all DEX-treated groups across the three dosing regimens. We conclude that a plasma osteocalcin zenith at night exists in early life. A high DEX dose in the morning and low DEX dose in the evening may partially attenuate corticosteroid-induced suppression of bone formation and growth restriction.