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随机分配至不同动脉导管未闭(PDA)治疗目标的极低出生体重儿的神经发育结局:PHELBI随访研究

Neurodevelopmental outcomes of extremely low birthweight infants randomised to different PCO targets: the PHELBI follow-up study.

作者信息

Thome Ulrich H, Genzel-Boroviczeny Orsolya, Bohnhorst Bettina, Schmid Manuel, Fuchs Hans, Rohde Oliver, Avenarius Stefan, Topf Hans-Georg, Zimmermann Andrea, Faas Dirk, Timme Katharina, Kleinlein Barbara, Buxmann Horst, Schenk Wilfried, Segerer Hugo, Teig Norbert, Bläser Annett, Hentschel Roland, Heckmann Matthias, Schlösser Rolf, Peters Jochen, Rossi Rainer, Rascher Wolfgang, Böttger Ralf, Seidenberg Jürgen, Hansen Gesine, Zernickel Maria, Bode Harald, Dreyhaupt Jens, Muche Rainer, Hummler Helmut D

机构信息

Division of Neonatology, University Hospital for Children and Adolescents, University of Leipzig, Leipzig, Germany.

Division of Neonatology, IS Dr. von Hauner University Children's Hospital, Ludwig Maximilian University of Munich, München, Germany.

出版信息

Arch Dis Child Fetal Neonatal Ed. 2017 Sep;102(5):F376-F382. doi: 10.1136/archdischild-2016-311581. Epub 2017 Jan 13.

DOI:10.1136/archdischild-2016-311581
PMID:28087725
Abstract

BACKGROUND

Tolerating higher partial pressures of carbon dioxide (PCO) in mechanically ventilated extremely low birthweight infants to reduce ventilator-induced lung injury may have long-term neurodevelopmental side effects. This study analyses the results of neurodevelopmental follow-up of infants enrolled in a randomised multicentre trial.

METHODS

Infants (n=359) between 400 and 1000 g birth weight and 23 0/7-28 6/7 weeks gestational age who required endotracheal intubation and mechanical ventilation within 24 hours of birth were randomly assigned to high PCO or to a control group with mildly elevated PCO targets. Neurodevelopmental follow-up examinations were available for 85% of enrolled infants using the Bayley Scales of Infant Development II, the Gross Motor Function Classification System (GMFCS) and the Child Development Inventory (CDI).

RESULTS

There were no differences in body weight, length and head circumference between the two PCO target groups. Median Mental Developmental Index (MDI) values were 82 (60-96, high target) and 84 (58-96, p=0.79). Psychomotor Developmental Index (PDI) values were 84 (57-100) and 84 (65-96, p=0.73), respectively. Moreover, there was no difference in the number of infants with MDI or PDI <70 or <85 and the number of infants with a combined outcome of death or MDI<70 and death or PDI<70. No differences were found between results for GMFCS and CDI. The risk factors for MDI<70 or PDI<70 were intracranial haemorrhage, bronchopulmonary dysplasia, periventricular leukomalacia, necrotising enterocolitis and hydrocortisone treatment.

CONCLUSIONS

A higher PCO target did not influence neurodevelopmental outcomes in mechanically ventilated extremely preterm infants. Adjusting PCO targets to optimise short-term outcomes is a safe option.

TRIAL REGISTRATION NUMBER

ISRCTN56143743.

摘要

背景

在机械通气的极低出生体重儿中耐受更高的二氧化碳分压(PCO₂)以减少呼吸机诱导的肺损伤可能会产生长期的神经发育副作用。本研究分析了一项随机多中心试验中纳入婴儿的神经发育随访结果。

方法

出生体重在400至1000克之间且胎龄为23⁰/₇至28⁶/₇周、在出生后24小时内需气管插管和机械通气的婴儿(n = 359)被随机分配至高PCO₂组或PCO₂目标轻度升高的对照组。使用贝利婴儿发育量表第二版、粗大运动功能分类系统(GMFCS)和儿童发育量表(CDI)对85%的纳入婴儿进行了神经发育随访检查。

结果

两个PCO₂目标组之间的体重、身长和头围无差异。平均智力发育指数(MDI)值分别为82(60 - 96,高目标组)和84(58 - 96,p = 0.79)。精神运动发育指数(PDI)值分别为84(57 - 100)和84(65 - 96,p = 0.73)。此外,MDI或PDI < 70或< 85的婴儿数量以及死亡或MDI < 70和死亡或PDI < 70联合结局的婴儿数量无差异。GMFCS和CDI的结果之间未发现差异。MDI < 70或PDI < 70的危险因素为颅内出血、支气管肺发育不良、脑室周围白质软化、坏死性小肠结肠炎和氢化可的松治疗。

结论

较高的PCO₂目标对机械通气的极早产儿的神经发育结局无影响。调整PCO₂目标以优化短期结局是一种安全的选择。

试验注册号

ISRCTN56143743。

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