Maternite Regionale Universitaire, EA 3450 Devah, Université de Lorraine, Nancy, France.
Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France.
JAMA Pediatr. 2016 Apr;170(4):365-72. doi: 10.1001/jamapediatrics.2015.4617.
Although immature neonate survival has improved, there is an increased risk of developing bronchopulmonary dysplasia, leading to significant respiratory morbidity. Measures to reduce bronchopulmonary dysplasia are not always effective or have important adverse effects.
To evaluate the effect of late surfactant administration in infants with prolonged respiratory distress on ventilation duration, respiratory outcome at 36 weeks' postmenstrual age, and at 1 year postnatal age.
DESIGN, SETTING, AND PARTICIPANTS: Double-blind randomized clinical trial at 13 level III French perinatal centers. Participants included 118 neonates at less than 33 weeks' gestation who still required mechanical ventilation on day 14 (SD, 2) with fraction of inspired oxygen of more than 0.30. All survivors were eligible for follow-up. We performed an intent-to-treat analysis.
Infants received 200 mg/kg of poractant alfa (surfactant) or air after randomization. At 1 year, after parents' interview, infants underwent physical examination by pediatricians not aware of the randomization.
The duration of ventilation was the primary outcome. The combined outcome of death or bronchopulmonary dysplasia at 36 weeks' postmenstrual age and respiratory morbidity at 1 year of age were the main secondary outcome measures.
Of the 118 infants who participated in the study, 65 (55%) were male. Fraction of inspired oxygen requirements dropped after surfactant, but not air, for up to 24 hours after instillation (0.36 [0.11] vs 0.43 [0.18]; P < .005). Severe bronchopulmonary dysplasia/death rates at 36 weeks' postmenstrual age were similar (27.1% vs 35.6%; P = .32). Less surfactant-treated infants needed rehospitalization for respiratory problems after discharge (28.3% vs 51.1%; P = .03); 39.5% vs 50% needed respiratory physical therapy (P = .35). No difference was observed for weight (7.8 [1.2] kg vs 7.6 [1.1] kg), height (69 [5] cm vs 69 [3] cm), and head circumference (44.4 [1.7] cm vs 44.2 [1.7] cm) measured at follow-up, nor for neurodevelopment outcome.
Late surfactant administration did not alter the early course of bronchopulmonary dysplasia. However, surfactant-treated infants had reduced respiratory morbidity prior to 1 year of age.
clinicaltrials.gov Identifier: NCT01039285.
尽管不成熟新生儿的存活率有所提高，但患支气管肺发育不良的风险增加，导致显著的呼吸系统发病率。减少支气管肺发育不良的措施并不总是有效或有重要的不良反应。
评估对延长呼吸窘迫的 118 名胎龄小于 33 周的婴儿在第 14 天（标准差[SD]，2）时给予晚期表面活性剂治疗对通气持续时间、36 周龄时的呼吸结局以及 1 岁时的呼吸结局的影响。
设计、地点和参与者：在法国 13 个三级围产期中心进行的双盲随机临床试验。纳入标准为：仍需机械通气的 118 名胎龄小于 33 周的新生儿，在第 14 天（SD，2）时，吸入氧分数（FiO2）仍大于 0.30。所有幸存者均有资格进行随访。我们进行了意向治疗分析。
婴儿在随机分组后接受 200 mg/kg 的猪肺磷脂（表面活性剂）或空气。在 1 岁时，在父母接受访谈后，儿科医生对接受随机分组的婴儿进行体格检查。
通气持续时间是主要结局。36 周龄时死亡或支气管肺发育不良和 1 岁时呼吸系统发病率的联合结局是主要次要结局。
在参与研究的 118 名婴儿中，65 名（55%）为男性。表面活性剂组在给药后 24 小时内 FiO2 需求下降，但空气组没有下降（0.36[0.11]比 0.43[0.18]；P<0.005）。36 周龄时严重支气管肺发育不良/死亡的发生率相似（27.1%比 35.6%；P=0.32）。接受表面活性剂治疗的婴儿出院后因呼吸系统问题再次住院的比例较低（28.3%比 51.1%；P=0.03）；需要呼吸物理治疗的比例分别为 39.5%和 50%（P=0.35）。随访时，体重（7.8[1.2]kg 比 7.6[1.1]kg）、身高（69[5]cm 比 69[3]cm）和头围（44.4[1.7]cm 比 44.2[1.7]cm）以及神经发育结局无差异。
晚期表面活性剂给药并未改变支气管肺发育不良的早期病程。然而，接受表面活性剂治疗的婴儿在 1 岁之前呼吸系统发病率较低。
clinicaltrials.gov 标识符：NCT01039285。
