Walsh Michele C, Wilson-Costello Deanna, Zadell Arlene, Newman Nancy, Fanaroff Avroy
Rainbow Babies and Children's Hospital, Case Western Reserve University, Mailstop 6010, 11100 Euclid Avenue, Cleveland, OH 44106, USA.
J Perinatol. 2003 Sep;23(6):451-6. doi: 10.1038/sj.jp.7210963.
Bronchopulmonary dysplasia (BPD) is the focus of many intervention trials, yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians. Thus, we wished to define BPD by a standardized oxygen saturation monitoring at 36 weeks corrected age, and compare this physiologic definition with the standard clinical definition of BPD based solely on oxygen administration.
A total of 199 consecutive very low birthweight infants (VLBW, 501 to 1500 g birthweight) were assessed prospectively at 36+/-1 weeks corrected age. Neonates on positive pressure support or receiving >30% supplemental oxygen were assigned the outcome BPD. Those receiving < or =30% oxygen underwent a stepwise 2% reduction in supplemental oxygen to room air while under continuous observation and oxygen saturation monitoring. Outcomes of the test were "no BPD" (saturations > or =88% for 60 minutes) or "BPD" (saturation < 88%). At the conclusion of the test, all infants were returned to their baseline oxygen. Safety (apnea, bradycardia, increased oxygen use), inter-rater reliability, test-retest reliability, and validity of the physiologic definition vs the clinical definition were assessed.
A total of 199 VLBW were assessed, of whom 45 (36%) were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks corrected age. The physiologic definition identified 15 infants treated with oxygen who successfully passed the saturation monitoring test in room air. The physiologic definition diagnosed BPD in 30 (24%) of the cohort. All infants were safely studied. The test was highly reliable (inter-rater reliability, kappa=1.0; test-retest reliability, kappa=0.83) and highly correlated with discharge home in oxygen, length of hospital stay, and hospital readmissions in the first year of life.
The physiologic definition of BPD is safe, feasible, reliable, and valid and improves the precision of the diagnosis of BPD. This may be of benefit in future multicenter clinical trials.
支气管肺发育不良（BPD）是许多干预试验的重点，但仅基于氧疗的结局指标可能会因医生之间不同的氧疗标准而产生混淆。因此，我们希望通过在矫正年龄36周时进行标准化的血氧饱和度监测来定义BPD，并将这种生理学定义与仅基于氧疗的BPD标准临床定义进行比较。
对199例连续的极低出生体重儿（VLBW，出生体重501至1500克）在矫正年龄36±1周时进行前瞻性评估。接受正压支持或接受>30% 补充氧气的新生儿被判定为BPD结局。那些接受≤30% 氧气的新生儿在持续观察和血氧饱和度监测下，补充氧气以2% 的幅度逐步降至室内空气。测试结果为“无BPD”（血氧饱和度≥88% 持续60分钟）或“BPD”（血氧饱和度<88%）。测试结束时，所有婴儿恢复至基线氧疗。评估安全性（呼吸暂停、心动过缓、氧用量增加）、评分者间信度、重测信度以及生理学定义与临床定义的效度。
共评估了199例VLBW，其中45例（36%）根据矫正年龄36周时氧疗的临床定义被诊断为BPD。生理学定义确定了15例接受氧疗的婴儿在室内空气中成功通过了饱和度监测测试。生理学定义在该队列中的30例（24%）中诊断出BPD。所有婴儿均安全完成研究。该测试具有高度可靠性（评分者间信度，kappa = 1.0；重测信度，kappa = 0.83），并且与出院时吸氧、住院时间以及出生后第一年再次入院高度相关。
BPD的生理学定义安全、可行、可靠且有效，提高了BPD诊断的准确性。这可能对未来的多中心临床试验有益。
