Keller Roberta L, Feng Rui, DeMauro Sara B, Ferkol Thomas, Hardie William, Rogers Elizabeth E, Stevens Timothy P, Voynow Judith A, Bellamy Scarlett L, Shaw Pamela A, Moore Paul E
Pediatrics/Neonatology, University of California San Francisco, Benioff Children's Hospital, San Francisco, CA.
Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA.
J Pediatr. 2017 Aug;187:89-97.e3. doi: 10.1016/j.jpeds.2017.04.026. Epub 2017 May 17.
To assess the utility of clinical predictors of persistent respiratory morbidity in extremely low gestational age newborns (ELGANs).
We enrolled ELGANs (<29 weeks' gestation) at ≤7 postnatal days and collected antenatal and neonatal clinical data through 36 weeks' postmenstrual age. We surveyed caregivers at 3, 6, 9, and 12 months' corrected age to identify postdischarge respiratory morbidity, defined as hospitalization, home support (oxygen, tracheostomy, ventilation), medications, or symptoms (cough/wheeze). Infants were classified as having postprematurity respiratory disease (PRD, the primary study outcome) if respiratory morbidity persisted over ≥2 questionnaires. Infants were classified with severe respiratory morbidity if there were multiple hospitalizations, exposure to systemic steroids or pulmonary vasodilators, home oxygen after 3 months or mechanical ventilation, or symptoms despite inhaled corticosteroids. Mixed-effects models generated with data available at 1 day (perinatal) and 36 weeks' postmenstrual age were assessed for predictive accuracy.
Of 724 infants (918 ± 234 g, 26.7 ± 1.4 weeks' gestational age) classified for the primary outcome, 68.6% had PRD; 245 of 704 (34.8%) were classified as severe. Male sex, intrauterine growth restriction, maternal smoking, race/ethnicity, intubation at birth, and public insurance were retained in perinatal and 36-week models for both PRD and respiratory morbidity severity. The perinatal model accurately predicted PRD (c-statistic 0.858). Neither the 36-week model nor the addition of bronchopulmonary dysplasia to the perinatal model improved accuracy (0.856, 0.860); c-statistic for BPD alone was 0.907.
Both bronchopulmonary dysplasia and perinatal clinical data accurately identify ELGANs at risk for persistent and severe respiratory morbidity at 1 year.
ClinicalTrials.gov: NCT01435187.
评估极早早产儿(ELGANs)持续性呼吸道疾病临床预测指标的效用。
我们纳入出生后7天内胎龄小于29周的极早早产儿,并收集产前和新生儿临床数据直至孕龄36周。我们在矫正年龄3、6、9和12个月时对照顾者进行调查,以确定出院后呼吸道疾病,定义为住院、家庭支持(吸氧、气管造口术、通气)、药物治疗或症状(咳嗽/喘息)。如果呼吸道疾病在至少2份问卷中持续存在,则婴儿被分类为患有早产后期呼吸道疾病(PRD,主要研究结果)。如果有多次住院、使用全身类固醇或肺血管扩张剂、3个月后家庭吸氧或机械通气,或尽管使用吸入性皮质类固醇仍有症状,则婴儿被分类为患有严重呼吸道疾病。使用出生1天(围产期)和孕龄36周时可用的数据生成的混合效应模型评估预测准确性。
在724例被分类为主要结局的婴儿(918±234g,胎龄26.7±1.4周)中,68.6%患有PRD;704例中的245例(34.8%)被分类为严重。在围产期和36周模型中,男性、宫内生长受限、母亲吸烟、种族/民族、出生时插管和公共保险均与PRD及呼吸道疾病严重程度相关。围产期模型准确预测了PRD(c统计量0.858)。36周模型或在围产期模型中加入支气管肺发育不良均未提高预测准确性(0.856,0.860);单独支气管肺发育不良的c统计量为0.907。
支气管肺发育不良和围产期临床数据均能准确识别1岁时存在持续性和严重呼吸道疾病风险的极早早产儿。
ClinicalTrials.gov:NCT01435187。