Respiratory Syncytial Virus Prophylaxis With Palivizumab Is Not Associated With Improved Lung Function in Infants of Very Low Birth Weight at Early School Age

Ingmar Fortmann , Marie-Theres Dammann , Alexander Humberg , Hannah Kraft , Alexander Herz , Kathrin Hanke , Kirstin Faust , Isabell Ricklefs , Michael Zemlin , Johannes Liese , Geraldine Engels , Christoph Härtel , Carsten Fortmann-Grote , Matthias Volkmar Kopp , Folke Brinkmann , Egbert Herting , Wolfgang Göpel , Guido Stichtenoth , for the German Neonatal Network
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Abstract

Background

Prematurity and infection with respiratory syncytial virus (RSV) are major risk factors for impaired lung function beyond the neonatal period.

Research Question

What are the long-term effects of palivizumab immunoprophylaxis in the first year of life on lung function and frequency of bronchitis episodes in 5- to 6-year-old preterm infants?

Study Design and Methods

Preterm infants with a birth weight < 1,500 g (very low-birth weight infants [VLBWIs]) were enrolled in a German Neonatal Network cohort study between 2009 and 2016. Children were examined by a single follow-up team at 5 to 6 years of age. VLBWIs who received at least five doses of palivizumab were compared with children who never received palivizumab. Analyses were stratified by bronchopulmonary dysplasia (BPD) and gestational age. We analyzed FVC, FEV1, FEV1 to FVC ratio, and the risk of respiratory tract infections at 5 to 6 years of age via univariate analyses and linear and logistic regression models.

Results

Of 1,986 VLBWIs with follow-up at 5 to 6 years of age, 951 infants (48%) received immunoprophylaxis with palivizumab. Children with BPD (n = 1,019) showed a much lower FEV1 than children without BPD (median FEV1 z score, –1.51 vs –1.09; P < .001). However, FEV1 in children with BPD was not altered by palivizumab (median FEV1 z score in 698 children with BPD who received palivizumab, –1.57 [interquartile range, –0.75 to –2.43] vs in 320 children with BPD who did not receive palivizumab, –1.37 [interquartile range, –0.69 to –2.25]; P = .1). As for FEV1, we did not find any protective effects of palivizumab for other end points or in other risk groups.

Interpretation

Palivizumab immunoprophylaxis in VLBWIs is not associated with improved lung function or lower rates of respiratory tract infections in early school-age infants.

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使用帕利珠单抗预防呼吸道合胞病毒与学龄前极低出生体重儿肺功能的改善无关
研究背景早产和感染呼吸道合胞病毒(RSV)是新生儿期后肺功能受损的主要风险因素。研究问题帕利珠单抗免疫预防在出生后第一年对 5-6 岁早产儿肺功能和支气管炎发作频率的长期影响如何?研究设计与方法2009年至2016年间,一项德国新生儿网络队列研究对出生体重为1500克的早产儿(极低出生体重儿[VLBWIs])进行了登记。儿童在5至6岁时由一个随访小组进行检查。接受过至少五次帕利珠单抗治疗的超低体重儿与从未接受过帕利珠单抗治疗的儿童进行了比较。根据支气管肺发育不良(BPD)和胎龄进行分层分析。我们通过单变量分析、线性回归模型和逻辑回归模型分析了 5-6 岁时的 FVC、FEV1、FEV1 与 FVC 比值以及呼吸道感染风险。患有 BPD 的儿童(n = 1,019)的 FEV1 远低于未患 BPD 的儿童(FEV1 z 评分中位数,-1.51 vs -1.09; P <.001)。然而,帕利珠单抗并未改变BPD患儿的FEV1(接受帕利珠单抗治疗的698名BPD患儿的FEV1 z评分中位数为-1.57[四分位距范围为-0.75至-2.43],而未接受帕利珠单抗治疗的320名BPD患儿的FEV1 z评分中位数为-1.37[四分位距范围为-0.69至-2.25];P = .1)。至于 FEV1,我们没有发现帕利珠单抗对其他终点或其他风险组有任何保护作用。
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