在一项针对低出生体重男婴的随机试验中，出生时补充维生素A与一系列死亡事件以及早期生长发育不良有关，该试验比较了维生素A与口服脊髓灰质炎疫苗的效果。
Neonatal vitamin A supplementation associated with a cluster of deaths and poor early growth in a randomised trial among low-birth-weight boys of vitamin A versus oral polio vaccine at birth.
作者信息
Lund Najaaraq, Biering-Sørensen Sofie, Andersen Andreas, Monteiro Ivan, Camala Luis, Jørgensen Mathias Jul, Aaby Peter, Benn Christine Stabell
机构信息
Research Center for Vitamins and Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark.
出版信息
BMC Pediatr. 2014 Aug 28;14:214. doi: 10.1186/1471-2431-14-214.
BACKGROUND
The effect of oral polio vaccine administered already at birth (OPV0) on child survival was not examined before being recommended in 1985. Observational data suggested that OPV0 was harmful for boys, and trials have shown that neonatal vitamin A supplementation (NVAS) at birth may be beneficial for boys. We set out to test this research question in a randomised trial.
METHODS
The trial was carried out at the Bandim Health Project, Guinea-Bissau. We planned to enrol 900 low-birth weight (LBW) boys in a randomised trial to investigate whether NVAS instead of OPV0 could lower infant mortality for LBW boys. At birth, the children were randomised to OPV (usual treatment) or VAS (intervention treatment) and followed for 6 months for growth and 12 months for survival. Hazard Ratios (HR) for mortality were calculated using Cox regression. We compared the individual anthropometry measurements to the 2006 WHO growth reference. We compared differences in z-scores by linear regression. Relative risks (RR) of being stunted or underweight were calculated in Poisson regression models with robust standard errors.
RESULTS
In the rainy season we detected a cluster of deaths in the VAS group and the trial was halted immediately with 232 boys enrolled. The VAS group had significantly higher mortality than the OPV0 group in the rainy season (HR: 9.91 (1.23 - 80)). All deaths had had contact with the neonatal nursery; of seven VAS boys enrolled during one week in September, six died within two months of age, whereas only one died among the six boys receiving OPV (p = 0.05). Growth (weight and arm-circumference) in the VAS group was significantly worse until age 3 months.
CONCLUSION
VAS at birth instead of OPV was not beneficial for the LBW boys in this study. With the premature closure of the trial it was not possible to answer the research question. However, the results of this study call for extra caution when testing the effect of NVAS in the future.
TRIAL REGISTRATION
http://www.clinicaltrials.gov NCT00625482. Registered 18 February 2008.
背景
1985年口服脊髓灰质炎疫苗（OPV0）在出生时即接种对儿童生存的影响在被推荐使用前未进行过研究。观察性数据表明OPV0对男孩有害，而试验显示出生时补充维生素A（NVAS）可能对男孩有益。我们开展了一项随机试验来验证这一研究问题。
方法
该试验在几内亚比绍的班迪姆健康项目中进行。我们计划在一项随机试验中招募900名低体重男孩，以研究NVAS而非OPV0是否能降低低体重男孩的婴儿死亡率。出生时，将儿童随机分为OPV组（常规治疗）或VAS组（干预治疗），随访6个月观察生长情况，随访12个月观察生存情况。使用Cox回归计算死亡率的风险比（HR）。我们将个体人体测量数据与2006年世界卫生组织生长标准进行比较。通过线性回归比较z评分的差异。在具有稳健标准误的泊松回归模型中计算发育迟缓或体重不足的相对风险（RR）。
结果
在雨季，我们在VAS组中发现了一组死亡病例，试验立即停止，共招募了232名男孩。在雨季，VAS组的死亡率显著高于OPV0组（HR：9.91（1.23 - 80））。所有死亡病例都曾接触过新生儿病房；9月的一周内招募的7名VAS组男孩中，6名在2个月龄内死亡，而接受OPV的6名男孩中只有1名死亡（p = 0.05）。VAS组在3个月龄前的生长情况（体重和臂围）明显较差。
结论
在本研究中，出生时接种VAS而非OPV对低体重男孩并无益处。由于试验提前结束，无法回答研究问题。然而，本研究结果提示未来在测试NVAS的效果时需格外谨慎。
试验注册
http://www.clinicaltrials.gov NCT00625482。2008年2月18日注册。
Zotero 插件