Investigating N-3 Fatty Acids to prevent Neonatal Tobacco-related outcomeS (INFANTS): study protocol for a double-blind, randomized, placebo-controlled parallel clinical trial of n-3 polyunsaturated fatty acids in pregnant smokers.
Investigating N-3 Fatty Acids to prevent Neonatal Tobacco-related outcomeS (INFANTS): study protocol for a double-blind, randomized, placebo-controlled parallel clinical trial of n-3 polyunsaturated fatty acids in pregnant smokers.
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DOI：
10.1186/s13063-021-05865-7
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发表时间：
2021-12-14
期刊：
影响因子：
2.5
通讯作者：
Tindle HA
中科院分区：
文献类型：
--
作者：
Murff HJ;Greevy RA;Sanghani RS;Hartmann KE;Hartert TV;Graves CR;Lee SS;Tindle HA
怀孕期间吸烟是与不良妊娠结局相关的最重要的可改变危险因素，增加早产、宫内生长受限和婴儿猝死综合症的风险。不到一半的怀孕吸烟者可以自行戒烟。确定安全有效的疗法来预防与烟草相关的不良妊娠结局和/或促进孕妇戒烟将对公共卫生产生重大影响。吸烟与循环 n-3 长链多不饱和脂肪酸 (n-3 LCPUFA) 水平相对缺乏有关。最近的一项分析发现，与不吸烟者相比，在怀孕期间服用 n-3 LCPUFA 的吸烟者早产风险降低。研究表明，补充 n-3 LCPUFA 还可以减少对尼古丁的渴望和日常吸烟。因此，吸烟者可以通过补充 n-3 LCPUFA 来降低早产风险和/或提高戒烟率，从而受益。为了解决重要的知识空白，我们建议研究 N-3 脂肪酸以预防新生儿烟草相关后果（婴儿）。 INFANTS 研究是一项多中心、随机、双盲、安慰剂对照研究，将随机将 400 名怀孕吸烟者随机分配到补充 n-3 LCPUFA 或安慰剂组。参与者将在妊娠 12 至 24 周之间入组，并跟踪至产后 6 周。我们将从整个田纳西州中部的临床中心招募人员。我们将使用自我报告和经过验证的烟草暴露生物标志物来评估补充 12 周后的吸烟行为。我们将使用 n-3 LCPUFA 状态的生物标记来测量对补充的反应。我们的主要终点是早产，如分娩时的胎龄所反映的。我们的次要终点是 12 周时每天吸烟量相对基线的变化。本研究检验了以下假设：吸烟引起的 n-3 LCPUFA 缺乏会导致与烟草相关的不良妊娠结局，而怀孕吸烟者补充 n-3 LCPUFA 可能会预防这些并发症。如果我们的研究表明补充 n-3 LCPUFA 可以有效降低与烟草相关的不良新生儿结局的风险和/或减少怀孕期间的烟草使用，那么我们的结果可能会对妊娠护理和新生儿结局产生直接而重大的影响。 ClinicalTrials.gov NCT04417595。 2020年4月21日注册
Tobacco use during pregnancy is the most important modifiable risk factor associated with adverse pregnancy outcomes, increasing the risk of preterm birth, intrauterine growth restriction and sudden infant death syndrome. Fewer than half of pregnant smokers can quit on their own. Identifying safe and effective therapies to prevent tobacco-related adverse pregnancy outcomes and/or increase smoking cessation in pregnant women would have a substantial public health impact. Cigarette smoking is associated with a relative deficiency in circulating n-3 long-chain polyunsaturated fatty acid (n-3 LCPUFA) levels. A recent analysis found that smokers taking n-3 LCPUFAs during pregnancy had a reduction in preterm labor risk when compared to non-smokers. Studies have shown that supplemental n-3 LCPUFAs may also reduce nicotine cravings and daily cigarette use. Thus, smokers may benefit from supplemental n-3 LCPUFAs by lowering the risk of preterm labor and/or increased smoking cessation. To address important remaining knowledge gaps, we propose the Investigating N-3 Fatty Acids to prevent Neonatal Tobacco related outcomeS (INFANTS). The INFANTS study is a multicenter, randomized, double-blind, placebo-controlled study that will randomize 400 pregnant smokers to either supplemental n-3 LCPUFAs or placebo. Participants will be enrolled between 12 and 24 weeks’ gestation and followed until 6 weeks after delivery. We will recruit from clinical centers throughout Middle Tennessee. We will assess smoking behavior after 12 weeks of supplementation using self-report and validated biomarkers of tobacco exposure. We will measure response to supplementation using biological markers of n-3 LCPUFA status. Our primary endpoint will be preterm labor as reflected by gestational age at delivery. Our secondary endpoint will be change from baseline in cigarettes per day at 12 weeks. This study tests the hypothesis that smoking-induced n-3 LCPUFA deficiencies contribute to tobacco-related adverse pregnancy outcomes and that supplementation of n-3 LCPUFAs in pregnant smokers may prevent these complications. If our study demonstrates that supplemental n-3 LCPUFAs are effective at reducing the risk of tobacco-related adverse neonatal outcomes and/or reducing tobacco use during pregnancy, our results could have an immediate and major impact on pregnancy care and neonatal outcomes. ClinicalTrials.gov NCT04417595. Registered on April 21, 2020
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影响因子：
4.7
作者：
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通讯作者：
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DOI：
10.1016/s0002-9378(12)90878-9
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