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Effect of Maternal Docosahexaenoic Acid Supplementation on Bronchopulmonary Dysplasia–Free Survival in Breastfed Preterm Infants
JAMA ( IF 120.7 ) Pub Date : 2020-07-14 , DOI: 10.1001/jama.2020.8896
Isabelle Marc 1 , Bruno Piedboeuf 1 , Thierry Lacaze-Masmonteil 2 , William Fraser 3 , Benoît Mâsse 4, 5 , Ibrahim Mohamed 5 , Mosarrat Qureshi 6 , Jehier Afifi 7 , Brigitte Lemyre 8 , Georges Caouette 1 , Julie Bartholomew 9 , Anne Monique Nuyt 5 , Pierre Julien 10 , Anne Synnes 11 , Michel Lucas 12 , Thérèse Perreault 13 , Lannae Strueby 14 , Zenon Cieslak 15 , Kamran Yusuf 16 , Gustavo Pelligra 17 , Edith Massé 18 , Bodil Larsen 19 , Cecilia de Cabo 20 , Chelsea Ruth 20 , Faiza Khurshid 21 , Pascal M Lavoie 11
Affiliation  

Importance Maternal docosahexaenoic acid (DHA) supplementation may prevent bronchopulmonary dysplasia, but evidence remains inconclusive. Objective To determine whether maternal DHA supplementation during the neonatal period improves bronchopulmonary dysplasia-free survival in breastfed infants born before 29 weeks of gestation. Design, Setting, and Participants Superiority, placebo-controlled randomized clinical trial at 16 Canadian neonatal intensive care units (June 2015-April 2018 with last infant follow-up in July 2018). Lactating women who delivered before 29 weeks of gestation were enrolled within 72 hours of delivery. The trial intended to enroll 800 mothers, but was stopped earlier. Interventions There were 232 mothers (273 infants) assigned to oral capsules providing 1.2 g/d of DHA from randomization to 36 weeks' postmenstrual age and 229 mothers (255 infants) assigned to placebo capsules. Main Outcomes and Measures The primary outcome was bronchopulmonary dysplasia-free survival in infants at 36 weeks' postmenstrual age. There were 22 secondary outcomes, including mortality and bronchopulmonary dysplasia. Results Enrollment was stopped early due to concern for harm based on interim data from this trial and from another trial that was published during the course of this study. Among 461 mothers and their 528 infants (mean gestational age, 26.6 weeks [SD, 1.6 weeks]; 253 [47.9%] females), 375 mothers (81.3%) and 523 infants (99.1%) completed the trial. Overall, 147 of 268 infants (54.9%) in the DHA group vs 157 of 255 infants (61.6%) in the placebo group survived without bronchopulmonary dysplasia (absolute difference, -5.0% [95% CI, -11.6% to 2.6%]; relative risk, 0.91 [95% CI, 0.80 to 1.04], P = .18). Mortality occurred in 6.0% of infants in the DHA group vs 10.2% of infants in the placebo group (absolute difference, -3.9% [95% CI, -6.8% to 1.4%]; relative risk, 0.61 [95% CI, 0.33 to 1.13], P = .12). Bronchopulmonary dysplasia occurred in 41.7% of surviving infants in the DHA group vs 31.4% in the placebo group (absolute difference, 11.5% [95% CI, 2.3% to 23.2%]; relative risk, 1.36 [95% CI, 1.07 to 1.73], P = .01). Of 22 prespecified secondary outcomes, 19 were not significantly different. Conclusions and Relevance Among breastfed preterm infants born before 29 weeks of gestation, maternal docosahexaenoic acid supplementation during the neonatal period did not significantly improve bronchopulmonary dysplasia-free survival at 36 weeks' postmenstrual age compared with placebo. Study interpretation is limited by early trial termination. Trial Registration ClinicalTrials.gov Identifier: NCT02371460.

中文翻译:

母体二十二碳六烯酸补充剂对母乳喂养早产儿无支气管肺发育不良存活率的影响

重要性 母体二十二碳六烯酸 (DHA) 补充剂可以预防支气管肺发育不良,但证据仍然不确定。目的 确定在新生儿期母体补充 DHA 是否能改善妊娠 29 周前出生的母乳喂养婴儿的无支气管肺发育不良存活率。设计、设置和参与者 在加拿大 16 个新生儿重症监护病房(2015 年 6 月至 2018 年 4 月,最后一次婴儿随访时间为 2018 年 7 月)的优势、安慰剂对照随机临床试验。在妊娠 29 周前分娩的哺乳期妇女在分娩后 72 小时内入组。该试验计划招募 800 名母亲,但提前停止。干预措施 有 232 位母亲(273 名婴儿)被分配到从随机化到 36 周期间提供 1.2 g/d DHA 的口服胶囊 经后年龄和 229 位母亲(255 名婴儿)被分配到安慰剂胶囊。主要结果和措施 主要结果是经后 36 周婴儿的无支气管肺发育不良存活率。有 22 个次要结局,包括死亡率和支气管肺发育不良。结果 根据本试验和本研究过程中发表的另一项试验的中期数据,出于对伤害的担忧,提前停止招募。在 461 名母亲及其 528 名婴儿(平均胎龄,26.6 周 [SD,1.6 周];253 名 [47.9%] 女性)中,375 名母亲 (81.3%) 和 523 名婴儿 (99.1%) 完成了试验。总体而言,DHA 组 268 名婴儿中的 147 名 (54.9%) 与安慰剂组 255 名婴儿中的 157 名 (61.6%) 存活下来,没有支气管肺发育不良(绝对差异,-5.0% [95% CI,-11.6% 至 2.6%] ; 相对风险,0.91 [95% CI,0.80 至 1.04],P = .18)。DHA 组婴儿的死亡率为 6.0%,安慰剂组为 10.2%(绝对差异,-3.9% [95% CI,-6.8% 至 1.4%];相对风险,0.61 [95% CI,0.33到 1.13],P = .12)。DHA 组存活婴儿的支气管肺发育不良发生率为 41.7%,安慰剂组为 31.4%(绝对差异,11.5% [95% CI,2.3% 至 23.2%];相对风险,1.36 [95% CI,1.07 至 1.73] ],P = .01)。在 22 个预先指定的次要结果中,19 个没有显着差异。结论和相关性 在妊娠 29 周之前出生的母乳喂养早产儿中,与安慰剂相比,在新生儿期补充二十二碳六烯酸的母亲在 36 周后没有显着改善支气管肺发育不良的存活率。研究解释受到提前终止试验的限制。试验注册 ClinicalTrials.gov 标识符:NCT02371460。
更新日期:2020-07-14
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