Thomas Alderliesten, Emad Arasteh, Anne van Alphen, Floris Groenendaal, Jeroen Dudink, Manon Jnl Benders, Frank van Bel, Pma Lemmers
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Outcome assessors were blinded.</p><p><strong>Setting: </strong>Single centre.</p><p><strong>Patients: </strong>Infants <30 weeks gestational age (GA) with MABP in mm Hg <GA in weeks during the first 72 hours after birth, without overt signs of sepsis.</p><p><strong>Intervention: </strong>Random assignment to PH, initiating treatment on signs of low perfusion and/or a MABP 5 mm Hg below their GA in weeks, or standard treatment (ST), initiating treatment when MABP was <GA in weeks.</p><p><strong>Main outcome measures: </strong>Death, NDO at 24 months, and composite adverse outcome (death <i>or</i> cognitive <i>and/or</i> motor NDO below -1 SD).</p><p><strong>Results: </strong>86 infants were included, 57.3% of projected inclusions. Both cognitive NDO (PH-ST mean difference 0.8 (95% CI -5.6 to 7.3)) and motor NDO (mean difference 3.7 (-3.3 to 10.7)) were comparable. The relative risks for death (1.4 (0.6 to 3.7)) and composite adverse outcome (0.8 (0.5 to 1.3)) were comparable. The number of infants with inotropic support (n=19 (42.5%) vs 7 (15.2%), p=0.004) and duration of support (median 48.0 hours (IQR 26.8 to 77.5) vs 17.0 (14.0 to 37.0)) was lower in the PH group, with comparable MABPs.</p><p><strong>Conclusion: </strong>A PH approach in preterm infants is feasible. It leads to comparable blood pressures with less inotrope administration. 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引用次数: 0
摘要
目的：评估无明显脓毒症的早产儿出生后72小时特发性低平均动脉血压（MABP）的灌注方法（允许性低血压，PH）是否会影响24月龄时的神经发育结局（NDO）。设计：随机对照试验。结果评估者采用盲法。设置：单中心。干预措施：随机分配PH值，在低灌注和/或MABP在数周内低于GA 5毫米汞柱时开始治疗，或标准治疗（ST），在MABP达到时开始治疗。主要结局指标：死亡，24个月时NDO，和复合不良结局（死亡或认知和/或运动NDO低于-1 SD）。结果：纳入86例患儿，预计纳入率为57.3%。认知NDO （PH-ST平均差0.8 (95% CI -5.6至7.3)）和运动NDO（平均差3.7(-3.3至10.7)）具有可比性。死亡的相对风险（1.4(0.6 - 3.7)）和综合不良结局（0.8(0.5 - 1.3)）具有可比性。PH组接受肌力支持的婴儿数量(n=19 （42.5%) vs 7 (15.2%), p=0.004）和支持持续时间（中位数48.0小时（IQR 26.8至77.5）vs 17.0小时（14.0至37.0））较低，MABPs可比较。结论：PH入路治疗早产儿是可行的。它可以在减少肌力作用的情况下导致相当的血压。虽然动力不足，但我们没有发现PH对短期或长期结果的主要负面影响。试验注册号：NCT01434251。
Treatment of Hypotension of Prematurity: a randomised trial.
Objective: To evaluate whether a perfusion-based approach (permissive hypotension, PH) for idiopathic low mean arterial blood pressure (MABP) during the first 72 hours after birth in preterm infants without overt sepsis affects neurodevelopmental outcome (NDO) at 24 months of age.
Design: Randomised controlled trial. Outcome assessors were blinded.
Setting: Single centre.
Patients: Infants <30 weeks gestational age (GA) with MABP in mm Hg
Intervention: Random assignment to PH, initiating treatment on signs of low perfusion and/or a MABP 5 mm Hg below their GA in weeks, or standard treatment (ST), initiating treatment when MABP was
Main outcome measures: Death, NDO at 24 months, and composite adverse outcome (death or cognitive and/or motor NDO below -1 SD).
Results: 86 infants were included, 57.3% of projected inclusions. Both cognitive NDO (PH-ST mean difference 0.8 (95% CI -5.6 to 7.3)) and motor NDO (mean difference 3.7 (-3.3 to 10.7)) were comparable. The relative risks for death (1.4 (0.6 to 3.7)) and composite adverse outcome (0.8 (0.5 to 1.3)) were comparable. The number of infants with inotropic support (n=19 (42.5%) vs 7 (15.2%), p=0.004) and duration of support (median 48.0 hours (IQR 26.8 to 77.5) vs 17.0 (14.0 to 37.0)) was lower in the PH group, with comparable MABPs.
Conclusion: A PH approach in preterm infants is feasible. It leads to comparable blood pressures with less inotrope administration. Though underpowered, we did not detect a major negative impact of PH on short-term or long-term outcomes.
期刊介绍：
Archives of Disease in Childhood is an international peer review journal that aims to keep paediatricians and others up to date with advances in the diagnosis and treatment of childhood diseases as well as advocacy issues such as child protection. It focuses on all aspects of child health and disease from the perinatal period (in the Fetal and Neonatal edition) through to adolescence. ADC includes original research reports, commentaries, reviews of clinical and policy issues, and evidence reports. Areas covered include: community child health, public health, epidemiology, acute paediatrics, advocacy, and ethics.
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