Singh Prashant, Wadhwa Nitya, Lodha Rakesh, Sommerfelt Halvor, Aneja Satinder, Natchu Uma Chandra Mouli, Chandra Jagdish, Rath Bimbadhar, Sharma Vinod Kumar, Kumari Mohini, Saini Savita, Kabra Sushil Kumar, Bhatnagar Shinjini, Strand Tor A
Translational Health Science and Technology Institute, Gurgaon, India; Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.
PLoS One. 2015 Apr 24;10(4):e0124594. doi: 10.1371/journal.pone.0124594. eCollection 2015.
Serious bacterial infections continue to be an important cause of death and illness among infants in developing countries. Time to recovery could be considered a surrogate marker of severity of the infection. We therefore aimed to identify clinical and laboratory predictors of time to recovery in infants with probable serious bacterial infection (PSBI).
We used the dataset of 700 infants (7-120 days) enrolled in a randomised controlled trial in India in which 10mg of oral zinc or placebo was given to infants with PSBI. PSBI was defined as signs/symptoms of possible serious bacterial infection along with baseline C-reactive protein(CRP) level >12mg/L. Time to recovery was defined as time from enrolment to the end of a 2-day period with no symptoms/signs of PSBI and daily weight gain of at least 10g over 2 succesive days on exclusive oral feeding. Cox proportional hazard regression was used to measure the associations between relevant variables and time to recovery.
Infants who were formula fed prior to illness episode had 33% longer time to recovery (HR-0.67, 95%CI-0.52, 0.87) than those who were not. Being underweight (HR-0.84, 95%CI-0.70, 0.99), lethargic (HR-0.77, 95%CI-0.62, 0.96) and irritable (HR-0.81, 95%CI-0.66, 0.99) were independent predictors of time to recovery. Baseline CRP was significantly associated with time to recovery (P<0.001), higher CRP was associated with longer time to recovery and this association was nearly linear.
Simple clinical and laboratory parameters such as formula feeding prior to the illness, being underweight, lethargic, irritable and having elevated CRP levels could be used for early identification of infants with PSBI at risk for protracted illness and could guide prompt referral to higher centers in resource limited settings. This also provides prognostic information to clinicians and family as longer recovery time has economic and social implications on the family in our setting.
ClinicalTrials.gov NCT00347386.
在发展中国家，严重细菌感染仍是婴儿死亡和患病的重要原因。恢复时间可被视为感染严重程度的替代指标。因此，我们旨在确定可能患有严重细菌感染（PSBI）的婴儿恢复时间的临床和实验室预测因素。
我们使用了印度一项随机对照试验中700名婴儿（7至120天）的数据，该试验中，给患有PSBI的婴儿口服10毫克锌或安慰剂。PSBI被定义为可能存在严重细菌感染的体征/症状，同时基线C反应蛋白（CRP）水平>12毫克/升。恢复时间定义为从入组到连续2天无PSBI症状/体征且纯母乳喂养时连续2天每日体重增加至少10克的时间段结束。采用Cox比例风险回归来衡量相关变量与恢复时间之间的关联。
发病前采用配方奶喂养的婴儿恢复时间比未采用配方奶喂养的婴儿长33%（风险比-0.67，95%置信区间-0.52，0.87）。体重不足（风险比-0.84，95%置信区间-0.70，0.99）、嗜睡（风险比-0.77，95%置信区间-0.62，0.96）和易激惹（风险比-0.81，95%置信区间-0.66，0.99）是恢复时间的独立预测因素。基线CRP与恢复时间显著相关（P<0.001），CRP水平越高，恢复时间越长，且这种关联几乎呈线性。
一些简单的临床和实验室参数，如发病前采用配方奶喂养、体重不足、嗜睡、易激惹以及CRP水平升高，可用于早期识别有患长期疾病风险的PSBI婴儿，并可在资源有限的环境中指导及时转诊至上级医疗机构。这也为临床医生和家庭提供了预后信息，因为在我们的环境中，恢复时间较长对家庭有经济和社会影响。
ClinicalTrials.gov NCT00347386。
